Bio4C ProcessPad™ 21 CFR Part 11 Compliance White Paper

To promote the use of state-of-the-art technologies while ensuring that these new software solutions meet the safeguards and regulations of traditional paper-based record keeping, the FDA issued 21 CFR Part 11 regulations to establish standards under which new electronic documentation and electronic signatures are regarded trustworthy, reliable, and generally equivalent to paper records and handwritten signatures on paper.

Bio4C ProcessPad™ software is a data visualization, analytics, and process monitoring platform that securely acquires and stores batch processing and analytical testing data and makes the data available for continuous process verification, investigations, reporting, and process benchmarking operations for the pharmaceutical and biopharmaceutical industry.

Bio4C ProcessPad™ is used within organizations on applications where 21 CFR Part 11 is applicable. It aids organizations in their compliance efforts by meeting applicable requirements of 21 CFR Part 11. Additionally, software validation services are provided as part of a Bio4C ProcessPad™ deployment.