Web Document Management: What's There to Consider?
Marci L. Crane
October 30, 2008
I recently listened to a live presentation in which a former pharmaceutical representative told us of the amount of documentation required during the preparation of an NDA for ONE drug. The number of documents he informed us reached the millions but ONLY an approximate 125,000-150,000 of those documents actually reach the FDA. ONLY! The shocking aspect of this scenario however isn't the sheer amount of documentation used during IND and NDA preparation and submission processes but the sheer nakedness of the documentation itself. In other words, a large amount of pharmaceutical documentation is still left unprotected and when document management and integrity is compromised every aspect of a drug's harried pipeline takes "ten steps back."
Web Document Management for Pharmaceutical Companies
From the R&D phases to marketing and advertising, documentation is required by regulations and encouraged by standards (e.g., ISO). Every form of documentation, especially in highly regulated companies such as pharmaceutical organizations, should be stored in a web document management system and should be accessible only by approved users. Many of these documents will only be referred to on rare occasions but at the very least they are inaccessible to unapproved employees, well-meaning employees who might misplace the documents and--heaven forbid--nosy hackers.
Web Document Management for IND Documentation
On the other hand, a significant portion of the documentation prepared during IND processes will be referred to again and again and will be referred to by the FDA. This essential IND-related documentation should be circulated within a web document management system that allows for complete document control. From dual-protection passwords to web-based collaboration and from document revision control to PDF publishing options, a web document management solution should keep users accountable and documentation safe. Documentation should also be tracked and easily accessible to all approved personnel. This technology can be especially valuable to regulatory personnel who are strategizing for best practice IND submissions but will of course (when centralized) be valuable to any approved personnel member from R&D, regulatory, manufacturing and/or quality groups.
Web Document Management and Training
Web document management should also be integrated with training software. The advantage of web document management and training integration is the ability of the training application to automate and launch training tasks (and the tracking of those tasks) when an essential document is changed. Usually this aspect of a document management/collaboration/training software trio is most valuable for quality representatives when SOPs or quality manuals are updated or significantly revised and employees need to receive training related to these essential documents. The integration can be used however by HR groups, manufacturing groups, etc. With a centralized web document management, collaboration and training solution, all departments can easily access documentation, collaborate on that documentation and automatically launch training related to documentation (or training not necessarily related to any extant documentation) in a safe, controlled web environment.
Maintaining GLP Compliance
It is important to mention that maintaining GLP compliance during the conceptual phases of drug development can be difficult for regulatory teams as well but is simplified when all GLP-related documentation (i.e., all evidence, SOPs, etc.) can be labeled and tracked and--if a company has the right solution--later accessed, electronically organized and submitted for approval by the FDA.
Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information in regard to web document management, audit and process solutions valuable to the pharmaceutical industry, please feel free to contact a MasterControl representative.
Web Document Management for Pharmaceutical Companies
From the R&D phases to marketing and advertising, documentation is required by regulations and encouraged by standards (e.g., ISO). Every form of documentation, especially in highly regulated companies such as pharmaceutical organizations, should be stored in a web document management system and should be accessible only by approved users. Many of these documents will only be referred to on rare occasions but at the very least they are inaccessible to unapproved employees, well-meaning employees who might misplace the documents and--heaven forbid--nosy hackers.
Web Document Management for IND Documentation
On the other hand, a significant portion of the documentation prepared during IND processes will be referred to again and again and will be referred to by the FDA. This essential IND-related documentation should be circulated within a web document management system that allows for complete document control. From dual-protection passwords to web-based collaboration and from document revision control to PDF publishing options, a web document management solution should keep users accountable and documentation safe. Documentation should also be tracked and easily accessible to all approved personnel. This technology can be especially valuable to regulatory personnel who are strategizing for best practice IND submissions but will of course (when centralized) be valuable to any approved personnel member from R&D, regulatory, manufacturing and/or quality groups.
Web Document Management and Training
Web document management should also be integrated with training software. The advantage of web document management and training integration is the ability of the training application to automate and launch training tasks (and the tracking of those tasks) when an essential document is changed. Usually this aspect of a document management/collaboration/training software trio is most valuable for quality representatives when SOPs or quality manuals are updated or significantly revised and employees need to receive training related to these essential documents. The integration can be used however by HR groups, manufacturing groups, etc. With a centralized web document management, collaboration and training solution, all departments can easily access documentation, collaborate on that documentation and automatically launch training related to documentation (or training not necessarily related to any extant documentation) in a safe, controlled web environment.
Maintaining GLP Compliance
It is important to mention that maintaining GLP compliance during the conceptual phases of drug development can be difficult for regulatory teams as well but is simplified when all GLP-related documentation (i.e., all evidence, SOPs, etc.) can be labeled and tracked and--if a company has the right solution--later accessed, electronically organized and submitted for approval by the FDA.
Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information in regard to web document management, audit and process solutions valuable to the pharmaceutical industry, please feel free to contact a MasterControl representative.