FDA Data Integrity

FDA Data Integrity

In April this year the US authority FDA (Food and Drug Administration) published a Guidance document on Data Integrity and Compliance with cGMP addressed to the industry. It asks and answers 25 questions on the topic.

The regulation 21 CFR already covers articles about data integrity and compliance, so this guide represents the FDA’s current view on it.

It includes comments on audit trails, risk management and controls addressing software, hardware, personnel and documentation. It also stresses the importance of restricting access to computer systems used for cGMP purposes.
Like this the FDA tries to prevent alterations of specifications, process parameters, or manufacturing or testing methods.

The publication shows the FDA’s worries that data could be modified, falsified or deleted, which translates into the acronym “ALCOA”. Data has to be Attributable, Legible, Contemporanous, Original and Accurate. The industry sees this as a global challenge and in Germany for example there will be held workshops and conferences about it this year.

It should also be a signal to all pharma sites producing or testing raw materials, APIs or finished products. The manufacturing pharma industry as well as R&D labs have to make sure that they have the necessary processes in place for the next FDA auditor. Because for the FDA they will probably be guilty until proven innocent.

So it seems better to be safe than sorry. Many of our clients believe so, too, and decided to approve budgets for a Data Integrity Program. More often than not departments are already tight on staff to ensure dail business or have other ongoing projects that bind up the personnel who actually would have the knowledge for such an assignment.

We know the right freelance consultant for your Data Integrity Program. Be it for the planning, implementation of subsequent effective training for the new processes and systems. Our CSV and quality system specialists come from all over Europe so that one of them will always be close to you and know also local regulations.

We have the right quality system / CSV experts for your industry to

  • Conduct a GAP analysis to identify potential data integrity issues (the FDA encourages companies to be proactive about this)
  • Set up the project plan for QA/QC Manufacturing and R&D labs, KPIs, timelines and define responsibilities
  • Implement and carry out all necessary steps to achieve and sustain Data Integrity and Compliance according to cGMP
  • Review Audit Trails
  • Create training concepts and materials and train your personnel

You can “book” them on a freelance basis.

The same goes for all consultants. We are always looking forward to expanding our network. For example with quality freelancers who have expertise in FDA Data Integrity and will shortly need a new project. If you send us your CV we can get in touch proactively with you.


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