The Role of Empower Chromatography Data System in Assisting with Electronic Records Regulation Compliance

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White Papers

Regulated pharmaceutical and biotechnology companies serving the US market are currently striving to meet compliance with 21 CFR Part 11, the U.S. Food and Drug Administration’s (FDA) rule governing electronic records and electronic signatures. Companies providing product for countries other than the USA, are also expected to meet the relevant electronic record and Data Integrity requirements from the governing Health Authorities of those countries, with the Medicines and Healthcare products Regulatory Agency (MHRA) taking a lead in this area. Additionally the World Health Organization (WHO) and the Pharmaceutical Inspection Cooperation Scheme (PIC/s) have issued guidances for managing electronic records and data.

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