No time to read? Listen to this article:

Both QC and QA can help your organization be compliant with the necessary regulations and produce the best products possible.

Thus, understanding both terms is increasingly important, especially if you work with Quality Management Systems in Life Science industries like Pharmaceuticals, Biotech, or Medical Devices.

This article covers the definitions of QA and QC, their objectives, in an infographic format.

Furthermore, you will learn the main difference between Quality Assurance (QA) and Quality Control (QC), and the purpose of both QA and QC within an Electronic Quality Management System (eQMS).

• What is Quality Assurance (QA)?
• What is Quality Control (QC)?
• Difference Between Quality Control and Quality Assurance
• QA and QC Supporting System
• QA and QC in the Quality Management System

What is Quality Assurance (QA)?

The ISO 9000:2015 standard, clause 3.3.6 defines Quality Assurance as:

“part of quality management (3.3.4) focused on providing confidence that quality requirements (3.6.5) will be fulfilled”

Put differently, Quality Assurance (QA) relates to a set of planned activities within the product manufacturing process that ensure the safety and the quality of the product.

What is Quality Control (QC)?

The ISO 9000:2015 standard, clause 3.3.7 defines Quality Control as:

“part of quality management (3.3.4) focused on fulfilling quality requirements (3.6.5)”

In other words, Quality Control (QC) refers to the systematic set of processes used to ensure that the product meets the required quality standards.

Quality Assurance (QA) and Quality Control (QC) are necessary for your Quality Management System. Simply put, you cannot test for the quality of the output by focusing only on one or the other alone.

Difference Between Quality Control and Quality Assurance

The infographic “Quality Control VS Quality Assurance” below illustrates the main differences between the processes.

If you would like to use this infographic, use the embed code below:

Focus & Nature of QC and QA

The main objective of Quality Assurance (QA) is to prevent any defects before they occur when manufacturing the product. Quality Assurance (QA) is a proactive activity in nature – looking to reduce the number of defects by measuring the processes.

On the other hand, the main goal of Quality Control (QC) is to identify any possible issues, prevent them, if needed, and verify the quality of the product or output. By its nature Quality Control (QC) is a reactive activity, which you would want to complete after the Quality Assurance (QA).

Processes & Orientation of QC and QA

Examples of Quality Control (QC) activities are process-oriented, as they aim to prevent quality defects. Therefore, some of the Quality Assurance (QA) examples include processes like:

• Following Standard Operating Procedures (SOPs)
• Supplier Management
• Training Management
• Change control
• Project audits
• Documentation
• Process checklists

At the same time, Quality Control (QC) actions are product-oriented. Consequently, examples of Quality Control (QC) associated processes could be the following:

• Testing process
• Deliverable peer review
• Inspections
• Product sampling

Duration & Life Cycle of QA and QC

Typically, Quality Assurance (QA) is a medium to long-term process within the product design period. In contrast, Quality Control (QC) is a much shorter-term activity usually at the final stages when the output is produced. Therefore, you would want to plan such a set of QA activities throughout the whole development life cycle. While QC-related procedures you would typically place at the testing life cycle.

QA and QC as Tools

Another way of looking at Quality Assurance (QA) and Quality Control (QC) would be to recognize what type of tools those are. For example, you can perceive QA as a managerial tool for preventing various quality issues. At the same time, QC could be an operational tool, for identifying and correcting the defects before the product enters the market.

Responsibility

Further on, different kinds of personnel from your organization should be involved in both processes. Quality Assurance (QA) requires the whole team’s involvement. While only the designated testing team is responsible for the Quality Control (QC) procedures.

Your organization can achieve Quality Assurance (QA) by putting into practice a Quality Management System (QMS). This system will help with the prevention of quality issues in all departments of the firm. Furthermore, your company can attain Quality Control (QC) by finding & eliminating sources of quality problems via various activities and techniques like inspections, tests, and reviews, aimed to maintain and achieve quality.

QA and QC Supporting System

You can support Quality Assurance (QA) and Quality Control (QC) by implementing an Electronic Quality Management System (eQMS).

Such a system allows preventing, as well as identify and verify issues thanks to fundamental QMS elements like:

• Document Control
• eSignatures
• CAPA Management
• Supplier Management
• Training Management
• SOP Management
• Template Management
• Equipment Management

QA and QC in the Quality Management System

Quality Management System (QMS) focuses on optimizing the quality of the output and no wonder both Quality Assurance (QA) and Quality Control (QC) are the basis of a QMS. Moreover, together with the industry-specific quality legislations and standards, QA and QC make up the structure of the Quality Management System.

One of the fundamentals of ISO-9001, “continuous improvement” also suggests that the progress concerning Quality Assurance (QA) never stops. This means that you should always have a critical appraisal of your firm’s Quality Assurance (QA) System to ensure consistent improvements.

Final Thoughts

Both Quality Assurance (QA) and Quality Control (QC) are terms many people use interchangeably. However, the difference between the two is significant. You can see the main differences between QA and QC are visualized in the “Quality Assurance VS Quality Control” infographic.

Quality Assurance (QA) is a combination of activities throughout the manufacturing process that ensures the quality of the product. Consequently, Quality Control (QC) is a set of processes used to secure that the product meets the quality requirements. Although, both QA & QC use statistical tools that are explained in the book Quality Control with R (Cano et al. 2015).

The main point of Quality Assurance (QA) is to prevent any defects before they occur. Therefore, Quality Assurance (QA) is a proactive activity by its nature. On the contrary, Quality Control (QC) aims to identify any possible issues and verify the quality of the output. Inherently, Quality Control (QC) is a reactive activity and it is conducted only after the Quality Assurance (QA).

The post Quality Assurance (QA) vs Quality Control (QC) appeared first on SimplerQMS.

Experience of relevant consultants can help you with regulatory compliance, device design optimization and development, testing, and accessing the market quicker.

Nowadays, there is a wide variety of medical device consulting and manufacturing service companies, large and small, with a diversified set of offerings. This article helps answer some of the most important questions when selecting the right medical device consultant.

Here is what this article covers:

• What does a medical device consultant do?
• Tips for selecting the right consultant for your organization
• Role of the consultant
• Lists of medical device consulting firms

What Does a Medical Device Consultant Do?

A medical device consultant provides research, product development, regulatory services, and recommendations on a variety of other relevant areas.

A medical device consultant can guide you through several areas within medical device development and regulatory compliance.

Consultants can help you implement a medical device QMS software solution, choose the best pathway for regulatory compliance, improve the quality of your core processes, and create long-lasting value.

Typically, consultants have expertise in areas such as:

• Overall business strategy
• Quality Management System
• Regulatory Submissions
• Medical Device Classification
• Design & Development
• Clinical QMS
• Regulatory Affairs

Tips on Selecting the Right Consultant

Choosing the right consultant depends on several factors – project goals, company size, geographic location, budget, and more.

Ultimately, you want to pick the consultant that matches your needs the best. Here are some questions to ask yourself and things to keep in mind when selecting the right medical device consultant.

1. Decide if You Want To Work With a Consultancy or an Individual Consultant

If you decide to work with an individual consultant then you will need to do the due diligence of finding, evaluating, and choosing the right expert.

On the other hand, if you choose a consulting company, then the firm will likely assign one or more relevant consultants for you.

2. Identify Why You Need a Medical Device Consultant

Whether you hire an independent consultant or a medical device consultancy firm, you will want to be as specific as possible to match the competencies of the consultant to your needs. To find the right expert, define the project requirements, and ask yourself, “What needs to be done?”

At this stage, you also want to have a clearly defined project scope with outlined roles, deliverables, and timeline of the project.

The defined project scope will allow you to get the most out of the interview process and it will be useful during the design of the final consulting contract.

3. Does the Consultant’s Area of Expertise Match Your Project Goal?

The level of expertise for consultants can vary greatly, and typically the value that can be provided by the consultant drops once they get out of their area of expertise. Thus, you want to make sure that the consultant’s area of expertise matches the requirements of your project.

For example, a consultant might know all aspects of design controls or medical device complaint handling processes, but only has experience with orthopedic implants. However, you are trying to bring the new cardiac device to the market.

Although some processes might be similar both orthopedic implants and cardiac devices bring unique challenges.

Therefore, a consultant that is highly familiar with your industry and a specific product category, will be more likely to improve the overall quality of the project and take less amount of time to achieve those results.

4. Has the Consultant Worked With Your eQMS?

Whether or not the consultant has experience working with your current eQMS software should not be the most important factor when making the final decision.

Although, training your consultant on how to use your eQMS solution would only require you to invest more resources, making the real costs for the consultant even higher.

If the consultants have prior experience with your QMS software solution, they could also help you implement the best practices so that you could reap all the benefits of your eQMS.

5. Does the Consultant Have Experience With Similar Clients?

Smaller companies operate differently than larger companies. By nature, small companies, including medical device startups must be agile, which pushes them towards greater risks due to limited funding.

On the other hand, established companies have mature and advanced systems, which startups cannot implement so easily.

Consultants who worked in large medical device companies before providing independent consulting services may find it challenging to work with smaller companies.

At the same time, consultants who only have experience with smaller medical device companies might struggle with project deliverables for a large firm.

Therefore, make sure that the consultant has experience with companies of your size, so you can achieve the desired project outcome while using resources wisely.

6. Does the Consultant Work in a Favorable Geographical Location?

It is also important to consider the geographic location of the consultant. Especially if your project involves a consultant working at your location.

The consultant’s primary location might also be relevant when it comes to understanding local market conditions and requirements.

However, if your projects allow for remote work, then you should consider taking advantage of a wider talent selection. If you choose to work with a consultant remotely, project management might prove more challenging.

7. Interview the Consultants

Interviewing is an essential part of the selection process. During the interview, the consultant should be focused on the project scope and ask relevant questions about the project and the company.

Don’t just interview the consultancy’s owner or a lead consultant. Check the career background of each consultants’ team member, if possible. It might also be beneficial to include another person from your team who is highly knowledgeable of the subject, to challenge the expertise of the candidates.

8. Ask for References

Consultant’s references from past clients for whom they have done similar work is another way to ensure that the consultant is known for a high-quality service.

Make sure to check multiple references, not just one or two before making the final decision.

Bear in mind, that typically, consultants feature those clients that have a higher likelihood of giving a positive reference.

Therefore, consider connecting with some of the previous clients that are not listed as references and ask how it was to work with the consultant.

9. Pay Attention To Consultant’s Fees

At the end of the selection process, you want several consultants and/or consulting firms bidding for your project.

However, the total costs should not be the only determining factor when making the final decision. At the end of the day, the most important aspect is to get the highest possible value for your investment.

Low prices for consultancy may translate to high incurred costs later on. Therefore, choose a company that will deliver quality work even if you will have to pay more for it.

10. Does the Consultant Provide Other Services or Has an Established Network?

You might hire a consultant specifically for the upcoming FDA audit or seek help to get your medical device CE marked. Nevertheless, after the project completion, you don’t want to forget that the consultant exists and go searching for a new one whenever you have another project.

The consultant spent the time getting to know your company and the medical device you produce.

Therefore, you should consider what other useful competencies might be the consultant able to provide.

Besides, a consultant’s network is another asset you could benefit from. This is the case for consulting firms and especially for independent consultants.

Over the course of their careers, many consultants have probably worked with quite a few experts with different sets of skills. For this reason, you could benefit by choosing a medical device consultant that also has an established professional network.

This would allow you to easily get access to a particular expert you might need in future projects.

Role of the Consultant

Lastly, before you go ahead and hire a consultant, it is important to understand the consultant’s role.

The main reason why you would want to hire a medical device consultant is to provide you with valid and reliable information.

This way, a medical device consultant can supplement your knowledge and help you make better, more informed decisions.

At the end of the day, you must remember that the consultant is not a substitute for your responsibility. Therefore, you cannot solely rely on everything the consultants say.

Lists of Medical Device Consulting Firms

By now, you know that finding the right consultant for your medical device organization is not an easy task.

Fortunately, we have researched, and selected consulting firms located in different countries with experienced professionals in their respective specializations.

We included small to medium-sized consultancies specializing within areas such as Quality Assurance and Regulatory Affairs, as well as some other niche experts.

Access lists of medical device consultancies from different countries:

• Denmark
• Sweden
• Netherlands
• The United Kingdom and Ireland
• Switzerland

Final Thoughts

Many, small- to medium-sized medical device companies have great concepts.

However, they lack the experience and expertise in areas like Quality Assurance, Regulatory Affairs, Device Development, and others. Some of these tasks are usually outsourced to medical device consultants with expertise in such fields.

Although the best consultant will differ based on your specific needs, the article outlines some of the most important things you should be taking into consideration when selecting the right consultant for your medical device company.

Lastly, you have to understand that you should not entirely rely on the consultant, instead use the consultants to add to your knowledge and as a result make better decisions.

The post How To Choose the Right Consultant for Your Medical Device appeared first on SimplerQMS.

The relevant experience and expertise of a consultant can help with preparation for regulatory submissions, product development, clinical trials, and much more.

This article discusses the most important focus areas when selecting the right consultant for your pharmaceutical organization.

You will discover:

• What does a pharmaceutical consultant do?
• Key focus areas when selecting the right consultant for your company
• Lists of pharmaceutical Consulting Firms

What Does a Pharmaceutical Consultant Do?

A pharmaceutical consultant guides a company throughout all product lifecycle stages, including planning, designing, constructing, product testing, and commissioning processes.

Many consultants can also help you with very specific tasks like the implementation of eQMS software. They can also help you choose the best pathways for regulatory compliance and improve the quality of core drug development processes by providing guidance on GCP, GMP, and GLP.

Among areas where pharmaceutical consultants usually provide their expertise are:

• Pharmaceutical firm business strategy
• Pharmaceutical Quality Management System
• Product Design & Development
• Clinical Quality Management System
• Pharmacovigilance
• Regulatory Submissions

Key Focus Areas When Choosing the Right Pharmaceutical Consultant

The best pharmaceutical consultant for your company may be different depending on the goal of your project, company size, product lifecycle stage, and many other variables.

Therefore, you want to select the consultant that matches your specific needs most optimally. Below are listed the most important areas you should focus on when looking for the right pharmaceutical consultant for your firm.

Your Organization and Project Needs

Before you put consultants under the microscope, you should assess your needs and ask yourself the following questions.

Do We Want To Work With a Consulting Company or an Individual Consultant?

A consulting firm will help you by selecting the candidates for your project and present the most relevant consultants to you. On the other hand, if you want to work with an independent consultant you will have to do everything yourself – finding, evaluating, and choosing the right expert for your firm.

Why We Need a Pharmaceutical Consultant?

Nowadays, many pharmaceutical consultants provide a wide selection of services. At times such a variety of options can slow down your selection process. Therefore, you must specify all your project requirements from the start.

Ensure that roles, deliverables, and the timeline within your project scope are clearly defined. Explicitly defined project scope from the start will allow you to have a more meaningful interview process, and of course, will be useful when creating the consulting contract.

How Important Is Quality vs Speed in the Project?

If speed is the priority for your current project, then you will want to find a consultant who is used to addressing similar issues and who can get to work right away. If you have a complex project on your hands, the project scope becomes a much more important factor. Consider narrowing your project scope to complete a project within your timeline.

On the other hand, if quality is your success factor, then you will have to select a consultant who is highly competent and can deliver at the level you require.

Expertise and Experience of the Consultant

Once you have successfully answered the prior questions you should have a better idea of what kind of pharmaceutical consultant would be the right one for you. At his stage, you should start assessing individual consultants and their level of expertise.

Does the Consultant Have Relevant and Recent Experience?

Ensure that the consultant’s area of expertise and knowledge of an industry matches the requirements of your project. Besides, check if the consultant has direct experience working with projects that involve a similar type of pharmaceutical product.

The consultant that has relevant experience and knows all the ins and outs of your industry and the product category has a higher likelihood of delivering high-quality results in less amount of time.

Has the Consultant Worked With My eQMS?

Today, consultants must be familiar with modern eQMS software solutions. So, put an effort into finding out what types of systems did the consultant work with prior, and how did it help drive success in similar projects like yours.

If your project revolves around the implementation or upgrade of an Electronic Quality Management System (eQMS), you will want to work with a consultant who is knowledgeable of the best systems on the market currently. In this case, you can consider asking the consultant for eQMS recommendations.

If you already have a solid Pharmaceutical QMS software solution, consider asking your eQMS vendor for recommendations. A supplier may also know some pharmaceutical consultants who are highly competent in your software and can produce quality results.

Does the Consultant Work in a Favorable Geographical Location?

You might also want to consider the geographic location of the consultant. If your project involves the consultant working at the drug manufacturing site, then you would need he is from your country or neighboring countries.

If your project allows for remote work, then of course the geographic location is less relevant. Although, you might benefit greatly by hiring a consultant who has expert knowledge of the local market conditions and requirements. Especially if that is the country where you want to market your pharmaceutical product.

Interviews With the Consultants

Interviews are an essential part of the consultant selection process. Here are some critical questions you would want to answer when conducting the interviews.

Has the Consultant Worked With Firm at Our Product Lifecycle Stage?

There is a difference between companies who have released products to the market and the ones that are just preparing to release the first one. If you are a small company that is yet to release a product to market you would need a consultant that is used to working in similar situations.

Such a consultant should be willing to educate you about all the necessary aspects when releasing the product to market. On the other hand, if you have already released many pharmaceutical products to market, you will not need too much assistance from the consultant. Instead, the best consultant, in this case, would be the one who is ready to start the work and produce results immediately.

What Are the Consultant’s Success Criteria?

When you are getting closer to making the final hiring decision, it is important to keep the overall view in mind. Remember one of the previous questions from above – “How important is quality vs speed in the project?”

Are you looking for a consultant who can quickly help reach compliance with regulations or you are looking for a consultant who can be with you for the long-term and act as a strategic partner?

If your goal is to define quality in your organization to differentiate among the competitors, then you want a consultant with a desire to quality across all the project deliverables. So, make sure that the consultant’s success criteria are aligned with yours.

What Other Services Does the Consultant Provide?

Sometimes, you might want to hire a consultant to assist you with a short-term project, for example getting through the next pharmaceutical audit.

However, after the project closure, you would want to pharmaceutical consultant and/or his colleagues to be capable of helping you in future projects. Therefore, it is important to recognize what other competencies does the consultant or a consultancy firm brings to the table.

Examples here could be other skills that the consultant possesses, as well as an established professional network. Many pharmaceutical service providers offer not only consulting services but also manufacturing, labeling, packaging, and distribution services.

Consultants Fees

At the end of the day, consultants’ fees should not be the only determining factor for selecting an expert. Ultimately, you would want multiple consultancies and/or consultants bidding against your project scope and deliverables. However, choosing the cheapest option may cost you more in the long-term if the work is not done properly and/or completed in time.

Typically, if you are looking for short-duration assistance from the consultant, it will likely be more expensive. You may find that smaller consulting firms, usually, offer lower rates. However, recognize the disadvantage here. Even though lower business operating expenses allow smaller firms and individual consultants to offer their services for lower prices, they also have limited capacity. This can be a problem if you realize that the need for a consultant’s capacity is greater than anticipated, or you decide to accelerate your project schedule.

Lists of Pharmaceutical Consulting Firms

Finding the right consultant for your drug manufacturing company can be tough.

Fortunately, we have done some research, and picked consultancies as well as some individual consultants located in different countries with different specializations. For the most part, we included small to medium-sized consultancies specializing within areas such as Quality Assurance and Regulatory Affairs, which also provide have expertise in a variety of other areas.

See pharmaceutical consulting firms from different countries:

• Austria
• Denmark
• Sweden
• Netherlands
• The United Kingdom and Ireland
• Switzerland

Final Thoughts

Many pharma start-ups, as well as some small to medium companies, have great concepts but may lack experience in areas like Regulatory Affairs, Quality Assurance, Pharmacovigilance, and others. These tasks can easily be outsourced to specialized pharmaceutical consultants with expertise in such fields.

Although the right consultant will differ based on your specific needs, the article discusses the most important areas you should be focusing on when selecting the right consultant for your firm.

The post Key Areas When Selecting Pharmaceutical Consultant appeared first on SimplerQMS.

1. FiercePharma

About: FiercePharma covers the pharma waterfront, from late-stage drug development through the entire lifecycle—tracking regulatory approvals, payer negotiations, manufacturing, marketing, patent fights, government investigations, and regulation, M&A deals and beyond. 

Interesting posts: 

“Where do COVID-19 vaccine players stand on pricing? So far, it’s no profit, slight profit or undecided” (https://www.fiercepharma.com/pharma/where-do-covid-19-vaccine-players-stand-pricing-no-profit-slight-profit-or-discussions) 

“The top 10 drugs by sales increase in 2020” (https://www.fiercepharma.com/special-report/top-10-drugs-by-sales-increase-2020) 

Link: https://www.fiercepharma.com/ 

2. PharmaTimes

About: PharmaTimes offers a unique blend of news stories, interviews, features, case studies, analysis, and comment on the critical issues facing the pharma and healthcare sectors. 

Interesting posts: 

“The need for digitalisation of pharma R&D” (http://www.pharmatimes.com/web_exclusives/The_need_for_digitalisation_of_pharma_R_and_D_1342884) 

“Building a domestic manufacturing capacity” (http://www.pharmatimes.com/web_exclusives/Building_a_domestic_manufacturing_capacity_1341929) 

Link: http://www.pharmatimes.com/ 

3. Pharmaphorum

About: Pharmaphorum supports its pharmaceutical industry clients through both the reach and reputation of their publication, consultative and creative capabilities in marketing, medical, communications, and digital innovation. 

Interesting posts: 

“The Future of Oncology” (https://deep-dive.pharmaphorum.com/magazine/future-of-oncology-2020/cover/) 

“Patient Engagement” (https://deep-dive.pharmaphorum.com/magazine/patient-engagement/cover/) 

Link: https://pharmaphorum.com/ 

4. Elvesier

About: Elvesier helps institutions and professionals advance healthcare, open science, and improve performance for the benefit of humanity. Their blog reflects this, covering topics such as technology and operational efficiency. 

Interesting posts: 

“Readying Your Workforce for Digital Transformation” (https://pharma.elsevier.com/pharma-rd/readying-your-workforce-for-digital-transformation/) 

“How Are Regulatory Agencies Reacting to the Use of Real-World Evidence?” (https://pharma.elsevier.com/pharmacovigilance/how-are-regulatory-agencies-reacting-to-the-use-of-real-world-evidence/) 

Link: https://pharma.elsevier.com/ 

5. PharmTech 

About: PharmTech.com is an information source for all professionals in the global pharmaceutical manufacturing drug development community. They provide content on process development and manufacturing, formulation, drug delivery, ingredients, regulation, analytics, packaging, supply chain, and outsourcing. 

Interesting posts: 

“Global Regulatory Collaborations Aim to Speed Access to New Vaccines and Drugs” (http://www.pharmtech.com/global-regulatory-collaborations-aim-speed-access-new-vaccines-and-drugs-0) 

“The Evolving War on Drug Prices” (http://www.pharmtech.com/evolving-war-drug-prices-0) 

Link: http://www.pharmtech.com/ 

6. Pharmaceutical Commerce  

About: Pharmaceutical Commerce is written for biopharma commercial executive decision-makers focusing on business processes and the technologies involved in how approved drugs go to market.  

Link: https://pharmaceuticalcommerce.com/ 

7. European Pharmaceutical Review

About: European Pharmaceutical Review is the leading publication for up-to-the-minute information on all aspects of drug analysis, formulation, delivery, manufacturing, and regulation. 

Interesting posts:   

“Is global COVID-19 expertise accessible enough?” (https://www.europeanpharmaceuticalreview.com/article/123874/is-global-covid-19-expertise-accessible-enough/) 

“Comparison of new vaccine approaches – COVID-19” (https://www.europeanpharmaceuticalreview.com/article/122275/comparison-of-new-vaccine-approaches-covid-19/) 

Link: https://www.europeanpharmaceuticalreview.com/ 

8. The Catalyst 

About: The Catalyst by PhRA, offers the latest news and ideas of America`s biopharmaceutical companies. 

Interesting posts: 

“Study finds the pharmaceutical industry retains a smaller share of revenue than research-intensive industries” (https://catalyst.phrma.org/study-finds-the-pharmaceutical-industry-retains-a-smaller-share-of-revenue-than-research-intensive-industries) 

“It’s a good thing pharmaceutical manufacturing supply chains are spread out around the world” (https://catalyst.phrma.org/its-a-good-thing-pharmaceutical-manufacturing-supply-chains-are-spread-out-around-the-world) 

Link: https://catalyst.phrma.org/ 

9. Pharma Pathway 

About: Pharma Pathway is a Pharma & Health network. It is a destination for information related to pharmaceutical manufacturing and healthy livings. Pharma network provides Guidelines, Standard Operating Procedure, Validation, Calibration, and much more information. 

Interesting posts:  

“Quality By Design and It’s Essential Elements” (https://pharmapathway.com/quality-design-essential-elements/) 

“Corrective and Preventive Action” (https://pharmapathway.com/corrective-preventive-action/) 

Link: https://pharmapathway.com/ 

10. Certara

About: Certara is the leading drug development consultancy with solutions spanning the discovery, preclinical and clinical stages of drug development. The mission is to help our customers accelerate decision making and enable the cross-disciplinary approaches necessary for translational science. 

Interesting posts:  

“The Research to Accelerate Cures and Equity (RACE) for Children Act: Changing the Landscape of Pediatric Cancer Drug Development” (https://www.certara.com/blog/the-research-to-accelerate-cures-and-equity-race-for-children-act-changing-the-landscape-of-pediatric-cancer-drug-development/) 

“The Value of Modeling and Simulation in Vaccine Development” (https://www.certara.com/blog/the-value-of-modeling-and-simulation-in-vaccine-development/) 

Link: https://www.certara.com/ 

11. Pharma Voice  

About: PharmaVOICE is a resource for life-sciences executives and other healthcare-service related professionals. The primary audience is made up of executive and corporate management from pharmaceutical, biotechnology, drug delivery, marketing communications, clinical services, contract research, drug development, and information technology companies, as well as other industry sectors. 

Link: https://www.pharmavoice.com/ 

12. Pharmaceutical Microbiology   

About: Dr. Tim Sandle is a chartered biologist and holds a first–class honors degree in Applied Biology; a Master‘s degree in education; and has a doctorate from Keele University. In his blog, Pharmaceutical Microbiology, Dr. Tim Sandle explores several topics related to microbiology. 

Interesting posts:  

“Artificial intelligence finds new antibiotic” (https://www.pharmamicroresources.com/2020/06/artificial-intelligence-finds-new.html) 

“Communities of microbes found to have working memory” (https://www.pharmamicroresources.com/2020/06/communities-of-microbes-found-to-have.html) 

Link: https://www.pharmamicroresources.com/ 

13. World Pharma News  

About: World Pharma News is one of the world’s leading web-based pharmaceutical news publications, committed to providing and disseminating the most prominent pharmaceutical news and achievement 

Interesting posts: 

“Can bilingualism protect the brain even with early stages of dementia?” (https://www.worldpharmanews.com/research/5132-can-bilingualism-protect-the-brain-even-with-early-stages-of-dementia) 

“Personalized cancer vaccines” (https://www.worldpharmanews.com/research/5127-personalized-cancer-vaccines) 

Link: https://www.worldpharmanews.com/ 

14. Pharma Manufacturing 

About: Pharma Manufacturing serves the informational needs of pharma and biopharma professionals in manufacturing and operations, QA and QC, regulatory affairs, engineering and project management, packaging, and corporate management. 

Interesting posts: 

“The world’s next ‘most expensive drug’ could soon be approved” (https://www.pharmamanufacturing.com/industrynews/2020/the-worlds-next-most-expensive-drug-could-soon-be-approved/) 

“Which drugs did Big Pharma hike prices for this year?” (https://www.pharmamanufacturing.com/industrynews/2019/which-drugs-did-big-pharma-hike-prices-for-this-year/) 

Link: https://www.pharmamanufacturing.com/?nav=logo 

15. Pharma Tutor  

About: This blog provides important insights for pharma students. It contains discussions in the pharmaceutical industry. It also provides information on interesting areas for researchers in this industry in addition to describing some job opportunities. 

Interesting posts: 

“Orodispersible liquisolid compacts: A novel approach to enhance solubility and bioavailability” (https://www.pharmatutor.org/magazines/articles/june-2018/orodispersible-liquisolid-compacts-a-novel-approach-to-enhance-solubility-and-bioavailability) 

“Ketamine: A Magic Remedy” (https://www.pharmatutor.org/magazines/articles/june-2018/ketamine-a-magic-remedy) 

Link: https://www.pharmatutor.org/ 

16. In Vivo  

About: In Vivo is a source for life sciences business strategy, covering the biopharma, Medtech, and diagnostics industries, offering a unique understanding of the forces shaping global healthcare. In their blog, you can find insider interviews with top industry executives and thought–provoking features that help you anticipate future industry trends and keep abreast of the latest in dealmaking, marketing, R&D, regulatory, and finance strategies. 

Interesting posts: 

“Making Progress Against Rare Diseases” (https://invivo.pharmaintelligence.informa.com/IV124478/Making-Progress-Against-Rare-Diseases) 

“Scenic Aims To Move ‘Genetic Modifiers’ Science Forward” (https://invivo.pharmaintelligence.informa.com/IV124562/Scenic-Aims-To-Move-Genetic-Modifiers-Science-Forward) 

Link: https://invivo.pharmaintelligence.informa.com/ 

17. STAT  

About: STAT gives you an inside look at academic labs, biotech boardrooms, and political backrooms. They examine with a critical eye scientific discovery, scrutinize corporate strategies, and chronicle roiling battles for talent, money, and market share.  

Interesting posts: 

“‘Inactive’ drug ingredients are not always inactive, study finds” (https://www.statnews.com/2020/07/23/inactive-drug-ingredients-are-not-always-inactive/) 

“Up and down the ladder: The latest comings and goings” (https://www.statnews.com/pharmalot/2020/06/12/ladder-jobs-amag-fda/) 

Link: https://www.statnews.com/ 

18. Eye for Pharma 

About: Known for their transparency and transparency, Reuters also brings you the latest news on the pharma industry, providing a hub for senior-level pharma executives, patient groups, and other health stakeholders to exchange ideas and observe shifting trends and practices. 

Interesting posts: 

“What patients need right now” (https://social.eyeforpharma.com/patients-and-medical/what-patients-need-right-now) 

“The key to digital innovation: The human touch” (https://social.eyeforpharma.com/medical/key-digital-innovation-human-touch)

Link: https://social.eyeforpharma.com/ 

19. Pharma IQ  

About: Pharma IQ was created for the pharmaceutical community to continue their conversations beyond events. In the past decade, the portal has evolved to be a leading hub for analysis, resources, and tools for all aspects of the pharmaceutical field. 

Interesting posts: 

“Connecting and leveraging quality-driven data throughout the pharma product life cycle” (https://www.pharma-iq.com/business-development/whitepapers/connecting-and-leveraging-quality-driven-data-throughout-the-pharma-product-life-cycle) 

“Solving the major challenges of data integration and analytics for translational medicine applications” (https://www.pharma-iq.com/business-development/articles/solving-major-challenges-data-integration-analytics-translational-medicine-applications) 

Link: https://www.pharma-iq.com/ 

20. PharmExec   

About: PharmExec, provides feature articles by guest columnists and staff writers. It is written from an executives’ point of view on regulatory issues, technology news, and marketing trends. 

Interesting posts: 

“Strategic Realignment for a Better Future” (http://www.pharmexec.com/strategic-realignment-better-future) 

“Are You Ready for the Telemedicine Revolution?” (http://www.pharmexec.com/are-you-ready-telemedicine-revolution) 

Link: http://www.pharmexec.com/ 

The post 20 Pharma Blogs to Watch appeared first on SimplerQMS.

1. Easy Medical Device

About: Medical Device expert, Monir, founded Easy Medical Device to help Medical Device companies to place compliant products on the market. Its objective is to share my knowledge and experience with the community of people working in the Medical Device field. 

Interesting posts: 

“Complete Guide: Medical Device Classification EU MDR (Free PDF)” (https://easymedicaldevice.com/new-eu-medical-device-classification/) 

“Process Validation or Verification (Medical Device)?” (https://easymedicaldevice.com/medical-device-validation/) 

Link: https://easymedicaldevice.com/blog/ 

2. Medical Device HQ

About: Medical Device HQ offers world-class training for talented individuals within the Medical Device Industry, as well as high-quality articles. The training process and content on the site is tailored around the product development of medical devices and related areas such as design control, project management, design control, risk management, and quality management.

Interesting posts: 

• Risk management for medical device and ISO 14971:2019 infographic
• A proactive approach to managing safety for electrical medical devices

Link: Medical Device HQ

3. Medical Device News Magazine

About: Medical Device News Magazine, located in the United States, reports the latest medical device industry news, clinical trials and updates, product launches, FDA announcements, profiles of device companies, acquisitions, executives on the move, non-profit and medical society news and more. Medical Device News Magazine distributes industry news to medical specialists, medical device industry executives, investors, and other allied health professionals. 

Interesting posts: 

“ The Impact of COVID-19 on Clinical Trials: Challenges an Opportunities” (https://infomeddnews.com/the-impact-of-covid-19-on-clinical-trials-challenges-and-opportunities/) 

“World`s First FDA IDE Coronary Patient Treated with a DEB” (https://infomeddnews.com/worlds-first-fda-ide-coronary-patient-treated-with-a-deb/)  

Link: https://infomeddnews.com/ 

4. EMERGO

About: Emergo by UL is a leading regulatory consulting firm specializing in global medical device and IVD compliance, present on six continents. This blog provides short updates on quality and regulatory topics. 

Interesting posts: 

“MDR Watch: Are Regulatory Affairs departments in need of more adequate support?” (https://www.emergobyul.com/blog/2020/01/mdr-watch-are-regulatory-affairs-departments-need-more-adequate-support) 

“US FDA 2020 agenda includes ISO 13485 harmonization, De Novo classification scheme” (https://www.emergobyul.com/blog/2020/07/us-fda-2020-agenda-includes-iso-13485-harmonization-de-novo-classification-scheme) 

Link: https://www.emergobyul.com/blog/ 

5. StarFish Medical

About: StarFish Medical provides medical device development services ranging from strategic planning and technology development to engineering, manufacturing, and regulatory support. StarFish Medical blog focuses on medical device innovation best practices. 

Interesting posts: 

“Reference designs for medical device development” (https://starfishmedical.com/blog/reference-designs-for-medical-device-development/) 

“Which standards apply to your medical device?” (https://starfishmedical.com/blog/which-standards-apply-to-your-medical-device/?doing_wp_cron=1595421144.2243471145629882812500) 

Link: https://starfishmedical.com/blog/ 

6. Verdict Medical Devices

About: Medicaldevice-network.com is your one–stop for information on the medical device industry, covering everything along the supply chain from biomaterials and materials solutions to electronics, packaging, motors and motion control, outsourcing, and more. 

Interesting posts: 

“Adapting the assembly line: how manufacturers are repurposing for Covid-19” (https://www.medicaldevice-network.com/features/adapting-the-assembly-line-how-manufacturers-are-repurposing-for-covid-19/) 

“Nanotechnology in Medicine: Regulatory Trends” (https://www.medicaldevice-network.com/comment/nanotechnology-medicine-regulatory/) 

Link: https://www.medicaldevice-network.com/ 

7. Medical News Today

About: Medical News Today, part of Healthline Media UK is one of the fastest–growing health information sites in the United States. Every month, more than 70 million people come to Medical News Today for in-depth health content and the latest news in medical research. They unravel the complexities of health information and make it easy to understand. 

Interesting posts:   

“What is differential diagnosis?” (https://www.medicalnewstoday.com/articles/differential-diagnosis) 

“How to use a nebulizer for a baby” 

(https://www.medicalnewstoday.com/articles/nebulizer-for-baby) 

Link: https://www.medicalnewstoday.com/categories/medical_devices 

8. Medgadget

About: Since 2004, Medgadget has been reporting on medical technology from around the world. They cover the latest medical devices and approvals, technology breakthroughs and discoveries, conduct exclusive interviews with med tech leaders, and file reports from healthcare conferences. 

Interesting posts: 

“Scientists 3D-Print Human Heart Pump” (https://www.medgadget.com/2020/07/scientists-3d-print-human-heart-pump.html) 

“Breathalyzer to Detect COVID-19 in Seconds” “https://www.medgadget.com/2020/06/breathalyzer-to-detect-covid-19-in-seconds.html” 

Link: https://www.medgadget.com/ 

9. MedCity News

About: MedCity News offers insight into what’s next and what matters with a mix of breaking news and analysis on startups, and established industry leaders, personalities, policies, and the most important deals. 

Interesting posts:  

“Here’s how Covid-19 has affected funding, development in infectious diseases” (https://medcitynews.com/2020/07/heres-how-covid-19-has-affected-funding-development-in-infectious-diseases/) 

“Digital health funding hits another high mark for 2020” (https://medcitynews.com/2020/07/digital-health-funding-hits-another-high-mark-for-2020/) 

Link: https://medcitynews.com/ 

10. Science Daily

About: ScienceDaily features breaking news about the latest discoveries in science, health, the environment, technology, and more — from leading universities, scientific journals, and research organizations. Stories are posted daily, selected from press materials provided by hundreds of sources from around the world. Links to sources and relevant journal citations (where available) are included at the end of each post. 

Interesting posts:  

“Quantum body scanner? What happens when vector vortex beams meet scattering media” (https://www.sciencedaily.com/releases/2020/07/200714143046.htm) 

“AI techniques in medical imaging may lead to incorrect diagnoses” (https://www.sciencedaily.com/releases/2020/05/200512134541.htm) 

Link: https://www.sciencedaily.com/news/health_medicine/medical_devices/ 

11. The Medical Futurist

About: The Medical Futurist focused on combining the future and the present of healthcare. Dr. Bertalan Mesko, Ph.D. is The Medical Futurist and the Director of The Medical Futurist Institute analyzing how science fiction technologies can become a reality in medicine and healthcare. 

Interesting posts: 

“Your Smartphone As The Swiss Knife Of Digital Health” (https://medicalfuturist.com/your-smartphone-as-the-swiss-knife-of-digital-health/) 

“Milestones Of Digital Health: Infographic About Its Timeline” 

(https://medicalfuturist.com/milestones-of-digital-health-infographic-about-its-timeline/) 

Link: https://medicalfuturist.com/ 

12. IMARC

About: IMARC Research is a global medical device CRO with two decades of proven experience ensuring patient protection and regulatory compliance for clinical research. In their blog, you can learn more about clinical monitoring and training.

Link: https://www.imarcresearch.com/blog 

13. Medical Device and Diagnostic Industry

About: Medical Device + Diagnostic Industry (MD+DI) is a resource exclusively for original equipment manufacturers of medical devices and in vitro diagnostic products. The goal of MD+DI is to help industry professionals develop, design, and manufacture medical products that comply with complex and demanding regulations and market requirements. 

Interesting posts: 

”Three Ways Healthcare QA Helps Improve Patient Outcomes” (https://www.mddionline.com/qaqc/three-ways-healthcare-qa-helps-improve-patient-outcomes) 

“How Ready Are You for the Next Crisis?” 

(https://www.mddionline.com/regulatory-quality/how-ready-are-you-next-crisis) 

Link: https://www.mddionline.com/ 

14. Operon Strategist

About: Operon Strategist is a medical device regulatory consulting company that provides regulatory advisory & guidance to various manufacturers in the healthcare industry. In their blog, you can find regulatory information and news from the medical device industry. 

Interesting posts: 

“Understanding About The Quality And Regulatory Affairs Of Medical Devices” (https://www.operonstrategist.com/quality-and-regulatory-affairs-of-medical-devices/) 

“Understanding between the NIOSH Approval and Food & Drug Administration/Centre for Devices & Radiological Health” (https://www.operonstrategist.com/niosh-approval-and-food-drug-administration/) 

Link: https://www.operonstrategist.com/blog/ 

15. Forma

About: Forma does medical industrial design, with an exclusive focus on medical devices and life science products. Being experienced medical product designers, their blog focusses on the path of an idea to market. 

Interesting posts: 

“10 Guidelines for Defining Medical Products” (https://www.formamedicaldevicedesign.com/2020/02/10-guidelines-for-defining-medical-products/) 

“What Is Your Patent Worth?” 

(https://www.formamedicaldevicedesign.com/2020/06/what-is-your-patent-worth/) 

Link: https://www.formamedicaldevicedesign.com/blog/ 

16. MedTech Impact

About: Medtech Impact on Wellness is an annual educational symposium that explores the landscape of digital health. MedTech hosts digital health stakeholders including clinicians, health IT executives, entrepreneurs, and researchers to promote the development of patient-centered medical technology.  Speakers at MedTech cover a diverse range of topics to fully tackle the varied and complex problems facing the healthcare industry. 

Interesting posts: 

“MedTech Insider: FDA Clears First AI X-Ray System” (https://www.medtechimpact.com/fda-clears-first-artificial-intelligence-x-ray-system/) 

“Left-Pocket/Right-Pocket: The Systemic Challenge Facing Health Tech Disruption” (https://www.medtechimpact.com/left-pocket-right-pocket-the-systemic-challenge-facing-health-tech-disruption/) 

Link: https://www.medtechimpact.com/ 

17. MobiHealthNews

About: MobiHealthNews is the publication of record for digital health, providing news, analysis, and data to innovators at provider groups, payers, pharma companies, tech, and venture capital firms as well as startups. For nearly 10 years, MobiHealthNews has identified and contextualized the emerging trends in digital health helping its readers shape what’s next in healthcare. 

Interesting posts: 

“The looming end to the telehealth boom” (https://www.mobihealthnews.com/news/looming-end-telehealth-boom) 

“HIMSSCast: What health startups need to be thinking about during COVID-19” 

(https://www.mobihealthnews.com/news/himsscast-what-health-startups-need-be-thinking-about-during-covid-19) 

Link: https://www.mobihealthnews.com/ 

18. Intertek

About: Intertek provides quality and safety solutions to a range of industries. Their blog offers insights into designing, marketing, and product development of medical devices. 

Interesting posts: 

“Connectivity in Medical Devices” (https://www.intertek.com/blog/2020-05-29-med-cybersecurity/) 

“Medical Robots and Robotic Devices” (https://www.intertek.com/blog/2019-06-18-med-robots/) 

Link: https://www.intertek.com/blog/medical-devices/ 

19. BioWorld

About: BioWorld’s suite of news services delivers actionable intelligence on the most innovative therapeutics and medical technologies in development. With writers and editors stationed around the globe, BioWorld reports the breaking news – and provides a key perspective on hundreds of therapeutics and devices in development, the companies behind those candidates, the business development transactions that evolve the markets, and the regulatory hurdles that both challenge and guard the processes. 

Interesting posts: 

“Transforming R&D and health care with artificial intelligence” (https://www.bioworld.com/articles/430100-transforming-r-d-and-health-care-with-artificial-intelligence) 

“AI propels med tech into new partnerships, new possibilities” 

(https://www.bioworld.com/articles/429874-ai-propels-med-tech-into-new-partnerships-new-possibilities) 

Link: https://www.bioworld.com/ 

20. Medical Devices Community

About: The medical devices community is dedicated to every individual active or interested in the medical devices industry. The purpose of this community is to create an international network with people from various disciplines who share interests, ideas, and experiences to learn from each other.  

Interesting posts: 

“A Virtual Experience of Medical Device Trials” (https://medicaldevicescommunity.com/md_news/a-virtual-experience-of-medical-device-trials/ 

“8 tips for telehealth regarding providers & patients” (https://medicaldevicescommunity.com/md_news/8-tips-for-telehealth-regarding-providers-patients/) 

Link: https://medicaldevicescommunity.com/news/ 

The post 20 MedTech Blogs to Follow appeared first on SimplerQMS.

What are the main reasons that so many life science companies are using a Manual Paper QMS instead of digitizing their Quality Processes with an eQMS? The key topics are:

• “It takes too much time”
• “The price is too high”
• “Vendors are unaware of the regulatory requirements”

Some learnings in the video are:

• Don’t try to digitize too many processes at once. You will be waiting too long for the benefit.
• Look for standard-solutions, which are not paid by Time and Materials
• Ask vendors about their certifications and regulatory experience

SimplerQMS is a Part 11 Compliant, Ready-to-use eQMS for Life Science Companies. We deliver a Validated Cloud Solution, we enable your company to work efficiently and paperless, while being in compliance with the regulatory authorities. Let us help you save time and money by digitizing your Quality Management System, Training, Design History File, Issues & CAPAs. SimplerQMS is ISO13485:2016 certified and in compliance with ISO14971:2019, FDA CFR 21 Part 820, FDA CFR 21 Part 11, EU MDR and GDPR.

The post Why Are Many Life Science Companies on a Paper-Based QMS appeared first on SimplerQMS.

We will discuss the benefits of remote audits and the obstacles to their implementation. We will also look at how digital tools such as an Electronic Quality Management System (eQMS) can make these remote audits successful.

What are remote audits?

Companies operating in regulated industries must undergo periodical audits by independent bodies or regulatory authorities. These audits are usually performed through physical visits to the audited companies, reviewing documents, and possibly research and manufacturing facilities. With changes in technology, it is now possible to perform remote audits, also known has e-audits, in which information is presented to auditors through forms such as live streaming and electronic documentation software.

Benefits and difficulties of performing remote audits

Benefits

A substantial amount of time is saved with a reduced, or even eliminated, need for commuting. This is even more substantial when considering companies that operate in remote regions, using foreign auditors, at a high cost.

The logistics of aggregating the required people for an effective audit is simplified by eliminating the need for physical meetings. People participating in the audit process can do so independently of their current location.

Difficulties

Many companies store their documents in paper binders, and some have scanned copies of documents in file folders. This makes it harder for the auditor to access the documents in a controlled way.

Trust is the main issue with conducting a remote audit, especially when audits involve research and manufacturing facilities. Physical access allows for a more thorough search for physical evidence that is crucial for identifying critical issues.

Some certification and accreditation bodies do not approve audits performed remotely. Besides the issues mentioned previously, there is a lack of decision on which parts of the audit process can and cannot be performed remotely.

EQMs and Remote Auditing

Audits involve an extensive review of a company’s information, a massive hurdle for the success of a remote audit, which is conducted using electronic tools. The adoption of an Electronic Quality Management System allows companies to digitize their quality management procedures. An electronic system allows for easy access, decreasing the time needed to find a document, being accessed remotely by an auditor.

Without the use of an eQMS, the cost and difficulty of performing a remote audit significantly increase. Instead of one system, many systems may become needed, such as email, Google Drive, DropBox, eSignatures, etc., creating organizational difficulties and usually involving the scanning of paper documents, which may compromise readability. Also, security and confidentiality are significant issues that conventional software has problems addressing. An eQMS enables the sharing of documents in a way that doesn’t compromise sensitive information, by disabling printing, placing “confidential” watermarks, giving time-limited access to records, etc.

To learn more about the preparation needed for as efficient and hassle-free audit as possible – read our article on remote auditing best practices!

SimplerQMS and Auditing

SimplerQMS understands the complexities surrounding audits, especially a remote one. Our system is designed to be time productive, allowing quick access to the required files and their sharing.

A reliable electronic system is vital for a successful audit, especially when FDA 21 CFR Part 11 compliance is needed.  Full compliance with 21 CFR Part 11 is provided to all our customers at no extra cost. We understand how important our system is for a successful audit, which is why we cooperate with our customers and auditors during the auditing process.

SimplerQMS has, through its years of expertise, understanding what is needed for a successful audit. We have the required documentation regarding the validation of our eQMS and the knowledge to talk to auditors directly about any issue regarding it. This can be done during a remote meeting.

We are ISO 13485:2016 certified and cover ISO 9001:2015, proving that our electronic system is validated and compliant with the most recent regulation. Remote auditing can be challenging, but with a trusted partner, who knows the needs and processes of the life science industry, it can become a genuine opportunity for your company to save time and money with SimplerQMS.

The post Advancing the use of Remote Audits in Life Sciences appeared first on SimplerQMS.

In this video, Jacob Sjørslev talks about what is needed to validate an Electronic Quality Management System (eQMS).

This validation activity is needed according to ISO13485:2016 7.5.6, 21 CFR Part 11 Subpart B and Annex 11.

The goal is to establish a level of confidence that the software is appropriate for its intended use and that it’s trustworthy and reliable. 

The post How to Validate an eQMS appeared first on SimplerQMS.

The SimplerQMS application will often be the first IT-system investment done by start-up’s. We strongly believe that starting with the smallest possible scope, which addresses the biggest needs, is the right approach. At the same time, we are ready to grow with our customers – from the early startup phase to mature post market companies.

With SimplerQMS, life science companies instantly gain the following key advantages:

• Modern secure cloud application running on Qualified Microsoft infrastructure compliant with ISO 9001:2015; ISO 27001:2013 and ISO 27018:2014
• Validated application compliant with ISO 13485:2016; FDA 21 CFR Part 820; FDA 21 CFR Part 11; Eudralex Annex 11 and GAMP5 which ensures you have electronic records and approvals accepted by regulatory authorities e.g. in Europe and USA.

By subscribing to SimplerQMS you:

• Get access to a prize winning best-in-class system credited both by Gartner and Forrester.
• Will run on a system that is easy to learn – based on Microsoft and directly integrated with all the Microsoft Office applications.
• Pay as you go – no initial investment in licenses, free implementation and data migration from legacy system(s).
• Have a virtual application working across time zones and locations, connecting internal staff and enable seamless collaboration with external stakeholders like QA/RA advisors and outsourcing partners used e.g. for research and development, manufacturing, customer service and supply chain. There is no need for complicated integrations. All records are available in one application you control.
• Ensure that everybody have access to what they need but with strict access controls.

Our SimplerQMS application enables you to:

• Manage your key entities as employees, suppliers, customers, equipment, products and projects through electronic approval flows
• Manage versioned templates
• Establish key value lists based on your own data: Departments, processes, archives and datatypes
• Manage and store all your QMS documents from policies, standard operating procedures, work instructions and forms
• Manage all your quality records in a single system and relate each record to your employees, suppliers, customers, equipment, products and/or projects
• Have the option to export your data and migrate to another system, if you SimplerQMS no longer suits your needs
• Can use prebuild connections to other systems within e.g. ERP, CRM, HRM and supplier invoice management.
• Take advantage of build-in connections between different key-processes and that all records can be created and archived in a single application you control.

We work globally with small life science companies and our mission is to become a key partner for hundreds of these companies over the next years. We know that many of these companies are struggling with manual processes and paper records. Let us help you focus on core business and not on pushing paper. Please contact me directly on +4593901646 or js@simplerqms.com if you want to hear about your options.

The post Why Choose SimplerQMS as Your eQMS? appeared first on SimplerQMS.

1. If you are going through hell – keep going

Churchill’s was not talking about building medical device companies, but his quote sure is relevant for some of these startup’s. Nearly all the startup’s we met had spent much more time and money than expected getting their first product ready for market. One of the common challenges was documenting the design and testing the product in a way that would be accepted by the regulatory authorities. Founders that had no or little experience in the medical device field often took year-long detours. However, most of them recuperated after an intense trial-and-error process. Their advice to new founders was to get experienced medical device experts on board quickly (as advisors or employees) – preferably people that had hands-on experience from running a medical device startup.

2. Everybody is working on manual paper-based processes

Another very surprising finding was that nearly all companies still based their Quality Management System (QMS) and Design History File on manual paper-based processes. Even companies that had an Electronic Quality Management System (eQMS) or digital content management (DCM) in place were printing and manually signing their records. The reason being that these systems were not validated and are therefore not ready for inspection by the regulatory bodies. Most medical device startup’s were simply using file folders and common file sharing tools like Box, OneDrive or Dropbox. This seemed to work well for a short period of time, until the manual process of printing and signing the documents became very cumbersome and time-consuming. Another finding was that many companies had lost track of which documents were still not signed and which version was the newest. Their advice was to think carefully about when the right time is to go digital. Because starting too early, when you are still ‘in the sandbox’, can cause a slow-down of the innovation process. However, waiting until a massive amount of documentation has been created is also a bad idea.

3. The perceived task of going digital is enormous

Migration. The task most people fear. Partly because it sometimes reveals a chunk of missing or unfinished business, but mostly because of the unknown amount of time it takes to get it done. When talking to the startup founders we often met the argument: “if we just knew how much work was ahead of us – or if somebody could help us migrate to a digital QMS – then we would do it”. It’s a tough call. You are already months or years behind on the product development and now you are asking your team to spend time on an activity like this. The key learning here was that the perceived task was often bigger than the actual task. Therefore, spending some time on doing a small pre-ject, where you analyze the actual task was recommended.

To summarize our findings all the startup’s were planning to fully digitize their QMS and DHF. However, most founders were not sure when was the right time to do this. We don’t have good answer for this question, because it varies from case to case. The timing aspect – or in other words “sandbox vs. design control” is an interesting subject, which we will look into in a later article. Please feel free to comment and share your own experiences.

The post Lessons Learned From 15 Medical Device Startups appeared first on SimplerQMS.