21 CFR Part 11 Applicability Assessment

The 21 CFR Part 11 applicability assessment is useful in determining whether an electronic system must comply with the requirements of 21 CFR Part 11.

By conducting the applicability assessment, Life Science companies can identify the specific 21 CFR Part 11 system controls necessary to ensure compliance. These controls encompass several procedures related to electronic records and electronic signatures.

This article provides an overview of the 21 CFR Part 11 applicability assessment and its steps. We will discuss how to determine the need for validation and effectively conduct and conclude the applicability assessment process.

Additionally, we will explore the role of compliant software solutions in achieving 21 CFR Part 11 compliance.

SimplerQMS provides fully 21 CFR Part 11-compliant eQMS software designed specifically for Life Science companies. Book a personalized demo and talk with our experts to learn how SimplerQMS can help you implement a QMS that reflects your compliance requirements.

This article covers the following topics in more detail:

• What is the 21 CFR Part 11 Applicability Assessment?
• 21 CFR Part 11 Applicability Assessment Steps
• Role of 21 CFR Part 11 Compliant Software

What is the 21 CFR Part 11 Applicability Assessment?

The 21 CFR Part 11 applicability assessment is a process used to determine whether a computerized system, which is used for managing electronic records and electronic signatures, falls under the requirements of 21 CFR Part 11 and specifically identifies which requirements are applicable.

The 21 CFR Part 11 requirements establish measures to ensure the trustworthiness, reliability, and equivalence of electronic records, electronic signatures, and handwritten signatures on electronic records to their paper counterparts.

The assessment provides a documented rationale for determining the need for particular controls and procedures to ensure compliance with specific parts of 21 CFR Part 11.

21 CFR Part 11 Applicability Assessment Steps

The 21 CFR Part 11 applicability assessment involves systematic steps to determine which compliance requirements apply to the electronic system.

Firstly, Life Science companies should define whether validation is required by evaluating if the system’s functions fall under the scope of applicable requirements.

Once validation requirements are determined, the assessment moves on to conduct a detailed evaluation, examining the system’s controls that may be needed concerning electronic records and signatures.

Finally, the assessment concludes by determining the minimum applicable 21 CFR Part 11 requirements and documenting the assessment findings.

At SimplerQMS, we utilize the Regulatory Criticality Assessment (RCA) as our 21 CFR Part 11 applicability assessment. The RCA Decision Pathway outlines the key questions that companies must address to determine what 21 CFR Part 11 controls may be needed.

Below is a simplified version of the 21 CFR Part 11 applicability assessment decision pathway.

Determine If Computer System Validation is Required

Computer system validation is required if processes within the company are regulated by any GxP regulations, FDA 21 CFR Part 11 and 820, and ISO 13485:2016.

Validation is necessary if these regulated processes involve controlled and documented electronic systems activities.

SimplerQMS provides a QMS software fully validated according to ISPE GAMP5 following a risk-based approach to computerized systems.

Our software is always maintained in a validated state. With each new version and standard update, we validate the system, saving you from the hassle of conducting validation activities yourself.

With SimplerQMS, you can eliminate additional costs, resource requirements, and time commitments associated with QMS software validation. We handle all the validation work, allowing you to focus on the core competencies of your Life Science company.

Conduct 21 CFR Part 11 Electronic Records Assessment

The 21 CFR Part 11 electronic records assessment determines if the system uses electronic records and the necessary controls and procedures to be implemented.

To properly evaluate the system, it is essential to determine if it serves the following purposes:

• Does the system store electronic records?
• Is the system of minor significance in creating records, performing simple data entry, or maintaining transient data?
• Is the system solely utilized for generating paper printouts of electronic records?
• Does the system rely on the internet or other open systems where the company does not control all system components?

Conclude on 21 CFR Part 11 Electronic Records Assessment

The conclusions of the 21 CFR Part 11 electronic records assessment are based on the system functions determined through the responses to the assessment questions above.

If the system stores electronic records, requires validation, and is a closed system, it must comply with the minimum requirements for electronic records outlined in 21 CFR Part 11.10.

The 21 CFR Part 11 requirements for electronic records are:

• 21 CFR 11.10(a): System validation.
• 21 CFR 11.10(b): Ability to generate accurate and complete copies of records.
• 21 CFR 11.10(c): Records protection and retrieval.
• 21 CFR 11.10(d): Limited system access.
• 21 CFR 11.10(e): Secure, computer-generated, and time-stamped audit trails.
• 21 CFR 11.10(f): Operational system checks.
• 21 CFR 11.10(g): Authority checks.
• 21 CFR 11.10(h): Device checks.
• 21 CFR 11.10(i): Appropriate personnel training and experience.
• 21 CFR 11.10(j): Implemented written policies.
• 21 CFR 11.10(k): Appropriate control of system documentation.

However, when the system is only utilized for generating printouts and has minor significance in record creation, companies may choose not to implement the requirements for electronic records mentioned above. In this case, companies must justify the system’s incidental use.

In cases where open systems are used, and validation is required, companies must implement requirements from 21 CFR Part 11.10 and 11.30.

These requirements specify additional security measures, such as document encryption and appropriate digital signature standards, to ensure data authenticity from the point of transmission to the receipt.

For further information about the difference between closed and open systems, read our article on this topic.

Conduct 21 CFR Part 11 Electronic Signatures Assessment

The 21 CFR Part 11 electronic signatures assessment evaluates if the system uses electronic signatures and must comply with the applicable regulatory requirements.

Companies should answer the following question about their systems:

• Does the system use electronic signatures to sign records as required by agency regulations or departmental SOPs?

Conclude on 21 CFR Part 11 Electronic Signatures Assessment

The conclusion of the 21 CFR Part 11 electronic signatures assessment is based on the answers obtained during the evaluation above.

If the system uses electronic signatures to sign records as required by agency regulations or departmental SOPs, it must comply with the minimum applicable 21 CFR Part 11 requirements for electronic signatures.

The requirements for electronic signatures as per 21 CFR Part 11 are:

• 21 CFR 11.50: Signature information included in the signed record.
• 21 CFR 11.70: Linked electronic signatures to their respective records.
• 21 CFR 11.100(a): Unique signature for each individual.
• 21 CFR 11.100(b): Verified users identity.
• 21 CFR 11.100(c): Handwritten signatures equivalent to electronic signatures.
• 21 CFR 11.200(a)(1): Two distinct identification components for non-biometric signatures.
• 21 CFR 11.200(a)(1)(i): Serial signing for non-biometric signatures. The first signing requires both signature components, and subsequent signings require one component.
• 21 CFR 11.200(a)(1)(ii): Non-Serial signing for non-biometric signatures. Require both components.
• 21 CFR 11.200(a)(2): Non-biometric signatures are used by their genuine owners.
• 21 CFR 11.200(a)(3): Required collaboration of individuals to prevent unauthorized use of non-biometric signatures.
• 21 CFR 11.200(b): Biometric signatures are used by their genuine owner.
• 21 CFR 11.300(a): Unique identification code and password combination.
• 21 CFR 11.300(b): Identification code and password are periodically checked.
• 21 CFR 11.300(c): Loss management procedures.
• 21 CFR 11.300(d): Transaction safeguards to prevent unauthorized use of passwords and identification codes.
• 21 CFR 11.300(e): Initial and periodic testing of devices.

If 21 CFR Part 11 is found to be necessary, you can use our 21 CFR Part 11 compliance checklist to evaluate the level of compliance with the requirements outlined in 21 CFR Part 11.

Role of 21 CFR Part 11 Compliant Software

21 CFR Part 11 compliant software solutions are specifically designed to meet the requirements outlined in 21 CFR Part 11, which governs electronic records and signatures.

By using 21 CFR Part 11 compliant software, Life Science companies can streamline their processes, improve data integrity, and effectively manage electronic records in a compliant manner.

They provide the necessary capabilities to help ensure the integrity, security, and authenticity of electronic records and signatures.

SimplerQMS provides an eQMS solution tailored to assist companies in streamlining their quality management processes and helping ensure compliance with the requirements of 21 CFR Part 11.

We offer a 21 CFR Part 11 compliant software solution and already went through the applicability assessment, so you can leave your worries about the applicability assessment behind.

SimplerQMS offers an eQMS software solution that goes beyond 21 CFR Part 11 compliance. Our platform supports compliance with various Life Science requirements, including ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 210, 211, and 820, EU GMP Annex 11, EU GMP, and more. With our extensive QMS process support, SimplerQMS software solution helps companies meet the necessary standards and regulations.

We offer Life Science QMS modules such as document management, change control, employee training, CAPA management, customer complaints, supplier management, and more.

To gain a deeper understanding of the advantages of implementing an eQMS solution, we recommend downloading our eQMS Business Case template.

The template is a valuable resource that offers a structured methodology for assessing the value of an eQMS customized to suit your company’s unique needs, enabling you to communicate your findings to management effectively.

You can uncover potential cost savings, better operational efficiency, and improved compliance through a comprehensive business case analysis.

Final Thoughts

The 21 CFR Part 11 applicability assessment is a process used to determine whether a computerized system utilized for managing electronic records and electronic signatures falls within the scope of the 21 CFR Part 11 requirements.

SimplerQMS utilizes the Regulatory Criticality Assessment (RCA) as our 21 CFR Part 11 applicability assessment, which includes a decision pathway with essential questions for companies to address to identify necessary 21 CFR Part 11 controls.

Implementing 21 CFR Part 11 compliant software solutions is essential for Life Science companies looking to improve data integrity, streamline processes, and effectively manage electronic records and signatures.

If you would like to learn more about how SimplerQMS can improve your quality management and compliance efforts, schedule a demo today to talk with our quality experts.