Data Integrity in Regulated Laboratories, Part 2

Data Integrity in Regulated Laboratories, Part 2

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Ensuring data integrity requires the management of many moving parts, as well as an understanding of regulatory terms and conditions. In this ebook, Data Integrity in Regulated Labs, Part 2, LCGC presents the next installment of a multipart series on data integrity, authored by R.D. McDowall, director of RD McDowall Ltd.

Featured articles, written by R.D. McDowall, include:

  • “Raw data” in EU GMP Chapter 4 and “complete data” in 21 CFR Part 211, and what it means for chromatographic analysis.
  • How USP "1058" affects data integrity generated by a chromatography data system.
  • The role of quality assurance in providing oversight on the data-integrity process.
  • The cost of non-compliance

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