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GMP Training – Introduction to Quality Control (QC) by www.gmpsop.com
6.16 The results obtained should be recorded and checked to make sure that
they are consistent with each other. Any calculations should be critically
examined.
Overview
Laboratory records are essential documents within any regulated laboratory, and
are generally checked during a regulatory audit. Records may be in hard copy,
in electronic formal, or a combination of the two.
Laboratory records:
provide evidence that tests were actually conducted
allow a second analyst to check results
allow traceability of standards and samples
allow tor out-of-specification (OOS) events to be investigated
assist in troubleshooting problems
Lab records may in some cases provide legal evidence of compliance.
Records should be archived in line with company-specified time periods.
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