Integrity Manager: Ensure compliance with FDA 21 CFR Part 11

The US Food and Drug Administration introduced FDA 21 CFR Part 11 in March 1997 to address the challenges associated with the growing digitalization of records and signatures within regulated industries, particularly in the pharmaceutical sector. As industries embraced digital transformation, encompassing data, electronic signatures, and archiving, the FDA established 21 CFR Part 11 to standardize the use of electronic systems, safeguard data integrity, and supplant paper-based records. While rooted in the US, the standard has exerted a profound global influence, especially within the pharmaceutical and biotech industries. These sectors have opted to align their image analysis processes with this standard for several compelling reasons. Firstly, standard’ adherence ensures regulatory compliance and fosters trust with regulatory authorities. Companies commercializing regulated products in the US must meet the mandatory requirement of complying with the standard, thereby enhancing their credibility with agencies like the FDA and expediting approval and market access processes. Secondly, adopting it guarantees data integrity and traceability. The stringent controls mandated by the standard ensure the reliability and reproducibility of image analysis results. The comprehensive traceability of data enables the tracking of modifications and the identification of responsible parties. Thirdly, the standard’ adoptions drives improvements in internal processes. Implementing systems that align with 21 CFR Part 11 can optimize workflows and boost efficiency. Lastly, having a system compliant with 21 CFR Part 11 streamlines regulatory audits.

Microvision Instruments, a premier French image analysis provider, empowers industries and institutions to meet their image analysis requirements. In response to the implementation of the 21 CFR Part 11 standard, we developed INTEGRITY MANAGER, a seamlessly integrated software module designed to ensure compliance with FDA regulations. By effortlessly overlaying your existing image analysis software (such as IMMULAB or FILTREX), INTEGRITY MANAGER enables you to adhere to data integrity, traceability, and archiving standards. With customizable role-based access, INTEGRITY MANAGER streamlines your operations and ensures regulatory compliance.