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FDA Announces Part 11 Inspections

Expected to begin in late 2010 or early 2011, the FDA's CDER will be inspecting for compliance to the 21 CFR Part 11 regulation during inspections (see the announcement).

It is anticipated that because chromatographic techniques are often used in cGMP-required analyses for purity, strength, quality, identity, and stability, Chromatographic Data Systems (CDS) may be audited.

What if I'm printing my LC data, do I need to keep the raw data or worry about electronic records or electronic data review?

Because of the nature of the data and metadata involved, a printed paper copy of a chromatogram cannot be considered an exact and complete true copy of the entire electronic raw data. In practical terms, what this means is that cGMP LC and GC analyses generate regulated electronic records, which have to be maintained and supported by controls to ensure data authenticity and integrity and other requirements as specified in 21 CFR Part 11 and the predicate rules.

Electronic data review is an essential element of good electronic data practices and has been specifically referenced by the FDA (see the 483).

Tools to help your laboratory prepare for the FDA's new Part 11 Inspection Assignment:


Assuring Electronic Data Integrity for Chromatography Data Systems

Reviewing Data Electronically with the Empower 2 software


Data Integrity Audits


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