Pharmaceutical Technologist - September/October 2008 - (Page 19)

Document management systems documents for GLP, including proof of laboratory equipment calibration and maintenance, must be managed, controlled and accessible for audit in a timely manner. Maintaining effective digital records assures regulatory authorities that the data submitted are a true reflection of the results obtained during a study, and that they can be relied upon when making risk/safety assessments. eDMS in the industry An eDMS can be used to sign documents with an electronic signature that proves the content is approved. Such documents should be sealed and encrypted, protecting their integrity. The signature solution should follow a standardsbased signing process using public key infrastructure technology, where each user has two keys: a public key and a private key. These keys can be used for encrypting and decrypting information, for electronically signing electronic documents, and for verifying the authenticity of their owner. If the document is altered afterwards, the sealed document changes and so the electronic signature is invalidated, thus making it as secure as a paper-based wet signature. eDMS could be of particular use to EU companies, which have the burden of translating documents into the language of the country of submission. This makes the management of documents and data in conventional paper-based forms extremely difficult, whereas an eDMS can reduce time and costs. The electronic document can be translated from source into whatever language is required, and all the corrections and versions managed in the electronic environment. Once given controlled access, the translation company can work on the original language document directly, reducing the time of writing, printing, shipping and management of multiple printed versions and corrections. In the US, regulatory submissions are increasingly being made through the Electronic Common Technical Document (eCTD). Traditional regulatory submissions usually involves physically sending large amounts of paper-based documentation to the relevant authorities. This can be a time-consuming and expensive process, especially when taking into account reviews or modifications made to documents throughout the development life cycle. Using eDMS can help improve and standardize the process of regulatory submissions; however, the electronic documentation must be subject to the same audit controls as paper-based information. Additionally, relevant electronic documents must be in a standardized format, with a full version history and audit trail. Document management and retrieval eDMS are already used by large pharmaceutical organizations, and can provide an effective and streamlined system for managing information, but the cost of buying and implementing such systems can be prohibitive for small- to mid-size companies, which then put themselves at risk from becoming overwhelmed with paperwork. Coupled with this is the retrieval of the right information at the right time. The information is (usually) in the organization somewhere, but could be on a local hard drive, in an e-mail or stored on a separate file partition. This problem could be resolved if the information was stored, catalogued. There are a number of factors that can help minimize the costs of eDMS adoption; for example, some new eDMS are built on collaborative platforms such as Microsoft SharePoint 2007 (part of the Microsoft Office 2007 suite). By using SharePoint as an existing platform, eDMS providers can reduce the retraining of staff in software use and the purchase of additional licenses (companies will often already have Microsoft Office, an SQL server and maybe even SharePoint licences) with the added benefit of easy integration into other line-of-business applications. Large project implementation costs are often increased by the need to purchase additional hardware to host the eDMS. However, some eDMS software can be hosted externally for smaller organizations and then accessed securely via the Internet. This helps to reduce training time as a web-based eDMS provides an easy-to-use environment where documents are interfaced with Microsoft Office. To further reduce the cost and resources involved with the implementation of eDMS, certain software providers offer a consultancy service advising organizations on how to install an eDMS at the lowest cost and with optimum efficiency. With larger established document management systems, inflexibility makes it necessary to change existing management processes to suit the software; however, other providers offer eDMS that are flexible enough to adapt to the pharmaceutical customer’s workflow. This approach Key dates January 2010 July 2009 Target for all NCAs to accept eCTD-only submissions eCTD strongly recommended as a submission format for Centralised applications e-only acceptance by all Member States for Centralised Procedure applications EU eCTD Module 1 specification v1.3 must be used for all eCTD submissions e-only acceptance by EMEA for Centralised Procedure applications January 2009 January 2009 July 2008 www.ptemagazine.com 19 http://www.ptemagazine.com

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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