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Image analysis software in pharmaceutical industry integrates several key features to facilitate various tasks within the industry. According to your needs, the software will include or be based on particle sizing and counting, particle shape analysis, texture and color analysis, image segmentation and thresholding, automated analysis and batch processing and reporting. Image analysis software in pharmaceutical industry are integrated to the laboratory equipment and offer user friendly interface and costumization to become a turnkey solution that complies with the industry regulation.

FDA21 CFR Part 11 is a crucial regulation for the pharmaceutical industry as it sets forth the criteria for the management of electronic records and electronic signatures to ensure they are trustworthy, reliable and equivalent to paper records and handwritten signatures. To comply with FDA21 CFR Part11, pharma industries must maintain records in a way that prevents unauthorized access and ensures data integrity. Systems must generate secure, computer-generated, time-stamped audit trails that record operator entries and actions. All charges to electronic records have to be traceable. According to FDA21 CFR Part 11, audit trails must be regularly reviewed and retained for a period in accordance with regulatory requirements. FDA21 CFR Part 11 standard also governs access to systems that must be restricted  to authorized individuals only by implementing user IDs and passwords. Mechanisms must be in place to ensure individual accountability for actions performed on the system, preventing unauthorized access or alterations. FDA21 CFR Part 11 standard also emphasizes maintaining data integrity throughout the record’s lifecycle, including preventing date corruption and ensuring records can be accurately retrieved. To resume, FDA21 CFR Part 11 is a pivotal regulation for the pharmaceutical industry, ensuring the integrity, reliability and equivalence of electronic records and signatures to their paper counterparts. Compliance with FDA21 CFR Part 11 not only helps in meeting regulatory requirements but also enhances data security, operational efficiency, and overall quality assurance. Microvision Instruments offers its Integrity software module as an option for using the various Microvision Instruments applications in full compliance with FDA21 CFR Part 11.

The Food and Drug Administration (FDA) plays a central and multidimensional role in regulating industries in the United States and globally, serving as an international reference for other regulatory bodies and all companies working with the United States (including exports). The FDA established the FDA 21 CFR Part 11 standard to regulate industries involved in food, drugs, medical devices, cosmetics, and other products that impact public health, ensuring user safety with the rise of digital processes to guarantee the same traceability with electronic records and electronic signatures as their paper counterparts. To support these companies, Microvision Instruments has developed specific software that allows full compliance with the FDA 21 CFR Part 11 standard. While using the image analysis software dedicated to specific issues (Filtrex, IMULAB…), the FDA 21 CFR Part 11 dedicated software compiles all electronic records and rigorously controls access to ensure that only authorized personnel can access electronic records and critical system functions. Every modification made to a record is tracked and timestamped, with the identity of the operator who made the change. All these records are available in an audit trail. The INTEGRITY software thus allows you to perform your image analyses in compliance with the FDA 21 CFR Part 11 standard.