Volume 28, Issue 2 - Generics and biosimilars
Document management systems for medical writing
Author: Brendan Thorne
Abstract
Clinical trial data are rightfully protected by robust regulations; given these requirements and increasing demands from clients, a validated and compliant electronic document management system is now a necessity for established medical writing organisations and contract research organisations. Even without this impetus, the improvements in admin istrative function, audit readiness, and team collaboration can justify the investment required.
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References
- FDA, CFR - Code of Federal Regulations Title 21, Volume 1. Revised: 01 April 2018 [cited 2019 April 26]. Available from: Available from: https://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfcfr/CFRSearch.cfm? CFRPart=11.
- Article 47 of European Commission Directive 2001/83/EC. Volume 4 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use. Annex 11: Computerised Systems. [cited 2019 April 26]. Available from: Available from: https://ec.europa.eu/health/sites/health/ files/files/eudralex/vol-4/annex11_01– 2011_en.pdf.
- FDA Guidance for Industry Part 11, Electronic Records; Electronic Signatures – Scope and Application. [cited 2019 April 26]. Available from: Available from: https://www.fda.gov/downloads/Regulatory Information/Guidances/ucm125125.pdf.
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