The complete documentation about the manufacturing and tracking of every medical device that your company sells is contained in a Device History Record (DHR). As per current international regulatory guidelines, your medical device company must maintain DHRs (or...
Medical device document management and control is the underpinning of your company’s Quality Management System. The documents and records that you maintain and how you control them will highlight to the world that your products are safe and efficacious to use. Under...
Considering the amount of documentation that is required for pharmaceutical companies, efficient document management is essential. Pharmaceutical document management can be defined as a repository of all the documents that your organization (be it pharmaceutical,...
Effective Date: 2022-06-30 ID: SQ-113 Description: This patch makes the Change Request process more robust. Improvement: Change Request Process is more stable and can handle more objects. ID: SQ-126 Description: This patch introduces a view for all documents that are...
When a life-sciences organization has an effective quality management system (QMS) in place, it is demonstrating to its end-users and the regulatory agencies that its products/services are of the highest industry standards. Similarly, when the sponsor of a clinical...
