Meeting 21 CFR Part 11 and EU GMP Annex 11 with Smartcontrol EM

Published: 21-Mar-2023

Electronic record keeping is the safest and most organised way to manage data and is now the norm across many industries

However, as with any system, it comes with challenges, not the least of which is finding the time to monitor whether data integrity requirements are being carried out to the required standards.

SmartControl EM from Microgenetics was designed by data integrity specialists to make it easy for laboratories to be more productive. Freeing time by providing secure, compliant, trustworthy electronic record keeping, in line with 21 CFR Part 11 and EU GMP Annex 11, is one of the ways it does this.

With SmartControl EM, electronic records are:

  • Secure – security is managed by Microgenetics, and the system can only be accessed by authorised users
  • Unchangeable - each electronic signature is unique and cannot be duplicated or copied to falsify records
  • Accountable – a second operator performs verification on all critical data entered
  • Monitorable - all steps are traced through date- and time-stamped audit trails, login verification and electronic signatures
  • Inspectable - all data produced is accessible and inspectable, understandable for both human and electronic review
  • Maintained - audit trails are stored alongside the underlying records for the required regulatory retention periods
  • Accessible - all audit trails are available for review

Anyone using electronic records must be able to demonstrate that they have taken all necessary steps to prevent the accidental loss or deletion of data and avoid security breaches. SmartControl EM provides everything needed to achieve this and many other environmental monitoring requirements.

“Data integrity is a well-understood and valued principle of pharmaceutical manufacturing; however, compliance with 21 CFR Part 11 and Annex 11 when using electronic systems can still be complex. Therefore, suppliers such as Microgenetics, that go out of their way to educate customers and assure compliance with ready-made, off the shelf solutions, take the worry out of implementation while providing innovative solutions to help manufacturing sites truly understand and generate value from their data in a compliant manner.” Tammy Hassel: Pharmaceutical Microbiology Consultant, A2Z Microbiology.

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