Pharmaceutical Technologist - September/October 2008 - (Page 20)

Document management systems can lower the overall cost of implementing such a system. For small- to mid-size companies, implementing an effective eDMS is now significantly more accessible. With the use of flexible eDMS, companies can enjoy benefits such as digital signatures. These have been upheld in US courts as the equivalent of wet signatures, and cover every requirement of 21 CFR Part 11 guidelines. Many electronic signature solutions are also easily integrated into commonly used programmes, such as Microsoft Office and Adobe. Conclusion Document management regulations are becoming increasingly rigorous, the amount of information being produced is escalating, and in the future it is likely that all regulatory submissions will need to be electronic.1 It is essential that companies employ effective document management solutions. An eDMS that has been specifically designed for the pharmaceutical industry can be manipulated to individual business processes. If coupled with further digital processes, such as digital signing and eCTD, further efficiency gains can be made. Good use of eDMS simplifies the storage and retrieval of essential records, creating a less painful documentation experience. PT Reference 1. www.fda.gov/cder/Regulatory/ersr/ waiver.htm Keith Williams is CEO, Good Products Ltd. Patrick Hughes is Senior VP, Strategic Business Development, Good Products Ltd. On the go ● ● ● ● Electronic document management systems offer a solution to effective document creation, approval, storage, revision control and retrieval. An eDMS must be methodically validated to ensure accuracy, reliability and consistency and must have the capability to retain, protect and readily retrieve records. Electronic documentation must be subject to the same audit controls as paper-based information. Some eDMS software can be hosted externally for and then accessed securely via the Internet. 20 SEPTEMBER/OCTOBER 2008 PHARMACEUTICAL TECHNOLOGIST http://www.fda.gov/cder/Regulatory/ersr/waiver.htm http://www.fda.gov/cder/Regulatory/ersr/waiver.htm

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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