FDA 21 CFR part 11 – Meeting the regulated requirements!

The US Federal Drug Administration (FDA) recently re-enforced its commitment to have all US Pharmaceutical Manufacturers comply with the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.

The regulations extend to but not limited to,  drug makers, medical device manufacturers, biotech companies, biologics developers, and other FDA-regulated industries.

This involves implementing stringent controls such as:

  • Secure access to the data
  • Traceability of the data collected – audit trials
  • Electronic signatures
  • Documentation for software and systems involved in processing electronic data related to the manufacturing of regulated products.

There are several options to meet these regulations such as in-house modifications of existing manufacturing  systems, purchase of a third party tailor made solution or turn to products like Quality Window 5 that are cost effective and flexible enough to “fill the gaps” in existing systems without having to perform extensive modifications to existing systems.

Quality Window applications can be configured to meet these stringent requirements.  Employing User based identification for the recording and editing of data.  Maintaining an Audit Trail traceability of all revisions to the data provide a secure environment for all the manufacturing data collected for regulated products.

The steps for upgrading a Quality Window 5 application to meet these requirements are quite simple.  Refer to article in our Self Help Blog – Meeting the 21 CFR part 11 requirements with Quality Window 5 for details.






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