FDA Compliance / Automation Validation of Automated Systems for FDA Compliance

| Author / Editor: Deepak Makhijani / Dominik Stephan

FDA regulatory compliance is a mission-critical requirement. If the FDA finds a manufacturer to be non-compliant to or in violation of FDA rules, the consequences can be severe with warning letters, mandatory product recalls, temporary shutdowns, criminal penalties and fines depending on the severity of the violation. These penalties imposed by FDA could seriously dent the manufacturer’s brand image and at times could even cripple the manufacturer financially.

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Enterprise solution should immutably be linked to all components of manufacturing – including equipment, raw materials and inventories. (Picture: Depositphotos)
Enterprise solution should immutably be linked to all components of manufacturing – including equipment, raw materials and inventories. (Picture: Depositphotos)

If a manufacturing process is highly automated, the basic process control system will play an important role in obtaining quality certification for the process. Every organisation, which utilises such systems, has a support structure of personnel and procedures to maintain and modify these systems, albeit in many cases this infrastructure may be lacking in documentation, producing a system that can be insecure and vulnerable for a process seeking quality certification. Whether trying to achieve certification or improve the integrity and security of this vital piece of operating equipment, one should take this opportunity to develop a methodology that not only documents the system’s logic, but also documents the personnel and procedures that support the system, as well. Accurate documentation is very vital.

This documentation provides guidance to persons, who in fulfillment in a statute or another part of FDA’s regulations to maintain records or submit designated information electronically and, as result, have become subject to part 11. Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in agency regulations. Part 11 also applies to electronic records submitted to the agency under the Federal Food, Drug and Cosmetic Act and Public Health Act (the PHS Act), even if such records are not specifically identified in agency regulations. The underlying requirements set forth in the Act, PHS Act and FDA regulations (other than part 11) are referred to in this guidance document as predicate rules.


FDA Compliance: 21 CFR Part 11 Demands

  • A common enterprise wide IT system to provide visibility into the processes and performance metrics at various operational and management levels.
  • Enterprise solution also should immutably be linked to all components of manufacturing (including equipment, raw materials and inventories) analytical laboratories as well for the distribution – purview of USFDA for capturing nonconformance out of spec production, tracking and managing the corrective action process
  • IT systems have to have audit trail forensuring successful implementation of recommendations
  • IT system should also improve efficiency and speed in operations as well as regulatory process

But what are the basics in terms of FDA compliance one has to keep in mind?

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