August 17, 2011

Video: Electronic FDA Compliance Made Easier with TestTrack

Helix ALM
Did you know that you can still comply with the FDA’s 21 CFR Part 11 policy for electronic document management without the hassle and frustration of using pen and paper or working in Microsoft Word? Paper and document-based systems really hamper a company’s ability to decrease time to market and enable more frequent “voice of the customer” feedback. It’s vital that life sciences companies understand they can remain compliant with the FDA by merely using the right system to manage records and electronic signatures. The key requirements of moving to an electronic data management system in compliance with Subpart B of the FDA’s 21 CFR Part 11 policy are outlined below:
  • Discern invalid and altered records
  • Provide accurate and complete records
  • Display records in a human-readable form, suitable for review and inspection
  • Prevent unauthorized access to records
  • Maintain time stamped audit trails for review and copying
TestTrack, which meets these requirements, can be used to manage life sciences product development, giving life science companies the ability to move away from outdated records management practices while retaining confidence in their ability to meet regulatory requirements. To learn more about improving your development practices with TestTrack, watch the following video and download our Six Exercises to Strengthen Traceability white paper. You can also schedule a private demonstration to learn more about TestTrack for life sciences organizations and to discuss your team’s needs.