Data integrity has become a major priority among regulatory investigators and audit trail deficiencies in particular have been cited in a growing number of enforcement actions.
While many firms understand the importance of configuring their systems to ensure audit trails are adequate and meet regulators expectations, many others still struggle to maintain electronic records with a complete and compliant audit trail.
Validated computer systems with enabled audit trails are necessary, but not sufficient, to meet global regulatory good documentation practice requirements for electronic records.Continue Reading
Data integrity issues are among the most significant compliance problems manufacturers struggle with today.
All too often, the scope of data integrity is misunderstood and oversimplified. Managing data and the systems that govern it stretch far beyond the IT department to encompass C-level executives and support groups in the areas of engineering, manufacturing, and quality. It requires a company-wide commitment to quality management that starts at the top.
Watch our free recorded webinar and get a refreshingly practical perspective on what data integrity is and how to mitigate data-related issues by developing and implementing a sound control framework. We also offer solutions to common data integrity problems.Continue Reading
Launched by the International Medical Devices Regulators Forum (IMDRF) in 2012, the Medical Device Single Audit Program (MDSAP) provides medical device manufacturers a way to simplify pre- and post-market audits required by regulatory authorities around the world.
Under the MDSAP, a single audit performed by an authorized Auditing Organization (AO) is deemed sufficient to evalaute compliance with the quality management system requirements of regulatory agencies in multiple major medical device markets, including the U.S., Canada, Japan, Brazil, and Australia. [White paper: The Medical Device Single Audit Program Pilot Explained]
This single audit approach reduces the need for duplicate quality management audits, helping device manufacturers better manage costs and access to markets around the world.
We've broken down the specific requirements, activities, and potential complications of a MDSAP audit along with important items every device manufacturer should consider.