FDA Compliance / Automation

Validation of Automated Systems for FDA Compliance

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Compliance auf Automation Systems: Basics

  • Any IT solution not linked to enterprise level is not going to serve the purpose
  • Any IT solution not linked to production, equipment, operators is going to fail the compliance test
  • Any IT solution at enterprise level, linking to facilities but not having audit trail would also fail (corollary: if an organisation does employ electronic records and signatures but fails to comply with the systems requirements, the USFDA would cite the firm for violating the underlying regulation – 21 CFR 211.198(b)).

As a outgrowth of its current Good Manufacturing Practice (cGMP) initiative for human and animal drugs and biologics, FDA is reexamining part 11 as it applies to all FDA regulated products. We anticipate initiating rulemaking to change part 11 as a result of this re-examination. FDA issued final part 11 regulations, which provide criteria for acceptance by FDA under certain circumstances, of electronic records, e-signatures and handwritten signatures executed to e-records as equivalent to paper records and handwritten signatures executed on paper. These rules that apply to all FDA program areas, were intended to permit the widest possible use of IT compatible with FDA’s responsibility.

Definition of part 11 records

FDA considers part 11 to be applicable to the following records or signatures in electronic format (part 11 records or signatures):

  • Records that are required to be maintained under predicate rule requirements, and that are maintained in e-format in place of paper format. Also, records (and any associated signatures) that are not required to be retained under predicate rules, but that are nonetheless maintained in e-format, are not part 11 records.
  • Records required to be maintained under predicate rules, that are maintained in eformat in addition to paper format, and that are relied on to perform regulated activities.

In some cases, actual business practices may dictate whether you use a computer to generate a paper printout of the e-records, but you however rely on the e-record to perform regulated activities, the agency may consider to be using the e-record instead of paper record. That is, the agency may take your business practices into account in determining whether part 11 applies.

Thus, we suggest that, for each record required to be maintained under predicate rules, you decide in advance if you plan to rely on the e-record or paper record to do regulated activities. We say that you document this decision (e.g. in a Standard Operating Procedure), or a specification document. So how does the audit procedure look like?