Pharmaceutical Technologist - September/October 2008 - (Page 18)

Reducing data burdens In the highly regulated pharmaceutical environment, it is crucial that all documentation be securely stored and easily accessed. Do electronic document management systems have the answer? Keith Williams Patrick Hughes from Good Products. I nformation and workloads are increasing, and there is a growing need for the effective management and organization of data. To overcome these challenges, many companies are employing electronic document management systems (eDMS). These computer-based systems offer a solution to effective document creation, approval, storage, revision control and retrieval. Regulatory concerns Companies produce and store significant amounts of electronic and paper-based data. Documentation can relate to many processes, such as drug R&D, manufacturing, clinical trials, distribution, marketing and sales reporting. Documents include, among other information, equipment standard operating procedures (SOPs), test protocols, validation documents, calibration certificates, reagent documentation, electronic laboratory books, laboratory-generated test results and printouts, material safety datasheets, quality manuals and training records. An eDMS enables all of these data to be securely stored and uniquely indexed. It allows document templates to be managed, and ensures document routing and delivery direct to the appropriate audience. In the pharmaceutical industry, a number of regulations govern electronic documents as they must be as reliable and trustworthy as their paper counterparts. FDA’s 21 CFR Part 11 rule defines the criteria under which electronic records and electronic signatures can be used. Predicate rules require that systems be methodically validated to ensure accuracy, reliability and consistency. They must also have the capability to retain, protect and readily retrieve records. An eDMS can also facilitate the processes associated with GLP; for example, the framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. These studies generate data by which the hazards and risks of a new product to users, consumers and third parties (including the environment) can be assessed. All associated 18 SEPTEMBER/OCTOBER 2008 PHARMACEUTICAL TECHNOLOGIST Jonathan Evans/Getty Images

Table of Contents Feed for the Digital Edition of Pharmaceutical Technologist - September/October 2008

Pharmaceutical Technologist - September/October 2008 Contents Industry Highlights Morpheus Market Watch Smoke and Mirrors Reducing Data Burdens Keeping it Simple Bringing Pharma Up to Date

Pharmaceutical Technologist - September/October 2008

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