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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: Courses:
Assuring Electronic Data Integrity for Chromatography Data Systems
Reviewing Data Electronically with the Empower 2 software
Services:
Data Integrity Audits
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