Enterprise Web Document Management in the Pharmaceutical Industry: Planting the Revenues of Tomorrow
Marci L. Crane
January 03, 2009
Doesn't it seem strange that one of the most advanced industries in the world (i.e., the pharmaceutical industry) still claims members (i.e., some pharmaceutical companies) that manage documentation with fork lifts, FedEx semis and paper cuts?
It's Catch Up Time
For many pharmaceutical companies, whether small or large, documentation has become a serious financial burden. Truckloads of documentation would obviously slow any industry's progress but for a highly regulated industry that continually relies on speed to set it apart from its competition, physical documentation is nothing more than a ball and chain. In fact, physical documentation will--without a doubt--ALWAYS generate the following challenges in the pharmaceutical environment:
Pharmaceutical Companies Know What They Need
Pharmaceutical companies need to shorten the time it takes for a product to "run the pipeline" and they need to quickly determine which compounds will not be profitable. Pharmaceutical companies can accomplish these endeavors more effectively when a document management system is integrated on the enterprise level. Why the enterprise level? If a document management system is only implemented within the development and/or marketing departments the risk of documentation loss and tampering remains high and most importantly real-time communication between departments become non-existent.1
An Enterprise Web Document Management System for Pharmaceutical Companies
When searching for a an enterprise-wide web document management system, pharma companies should search for a web-based solution that allows every department to collaborate, revise, route and report on documentation in real-time. The web document management system should also allow engineers to continue working with the solutions they are familiar with (e.g., CAD solutions) while still allowing their drawings to be automatically converted to PDFs (when the drawings are saved) and automatically stored and/or collaborated on within the web document management system. A web document management system should also be able to trigger training procedures automatically when changes to specific documents are made (e.g., SOPs).
Conclusion
It is apparent that web document management within the pharma industry in absolutely necessary and that enterprise-level web document management solutions come even more highly recommended. Enterprise-level web document management systems, when built to comply with a company's needs improve communication between departments and functioning satellites while simultaneously saving administrative time otherwise spent on the management of paper…and the Fed-Ex semis.
Notes
1. Take the purchasing department as an example. How many times has a purchasing department made purchasing errors due to the simple fact that real time information from the engineering department was not available?
2. With the pharma world revolving in the direction of global markets and harmonization (e.g., ICH Q8, Q9 and Q10) how can a pharma company risk even one information error when it comes to managing suppliers, CROs, etc?
Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information in regard to web document management for the enterprise, please feel free to contact a MasterControl representative.
It's Catch Up Time
For many pharmaceutical companies, whether small or large, documentation has become a serious financial burden. Truckloads of documentation would obviously slow any industry's progress but for a highly regulated industry that continually relies on speed to set it apart from its competition, physical documentation is nothing more than a ball and chain. In fact, physical documentation will--without a doubt--ALWAYS generate the following challenges in the pharmaceutical environment:
- Siloed Information Between Departments - Paper-based records cannot be transferred from department to department fast enough for decisions to be made based on real-time information. In many cases paper-based documentation results in decisions that are never made or made based on belated information1;
- Siloed Information Between Suppliers, CROs, etc. - Paper-based records (even with email and other disparate solutions) make it impossible to protect valuable information and to ensure that the right suppliers and/or CROs have received it and have routed and revised the information as needed2;
- Paper-Based Mishaps - When pharma companies use paper it's inevitable that some of that paper will be lost, that some will lie dormant on a desk for days, weeks, even months, and that some will be tampered with by the wrong people at the wrong time;
- Compliance Tragedies - When a pharma company spends years in the development and clinical trials of a compound the last thing it wants to hear is that it hasn't met regulatory standards. Physical paper, whether it has been left uncontrolled, or unconnected (lacks an audit trail) or has simply been lost, often becomes the missing link between a pharma company and its regulatory "counterparts";
- Smaller Window of Marketing Opportunity- No matter how a pharma company plays the submission game, paper-based submissions information and paper-based organization practices during drug development, clinical studies, manufacturing, etc. will continually slow the process of production over time and leave a pharma company with less market time and a smaller window of patented opportunity;
Pharmaceutical Companies Know What They Need
Pharmaceutical companies need to shorten the time it takes for a product to "run the pipeline" and they need to quickly determine which compounds will not be profitable. Pharmaceutical companies can accomplish these endeavors more effectively when a document management system is integrated on the enterprise level. Why the enterprise level? If a document management system is only implemented within the development and/or marketing departments the risk of documentation loss and tampering remains high and most importantly real-time communication between departments become non-existent.1
An Enterprise Web Document Management System for Pharmaceutical Companies
When searching for a an enterprise-wide web document management system, pharma companies should search for a web-based solution that allows every department to collaborate, revise, route and report on documentation in real-time. The web document management system should also allow engineers to continue working with the solutions they are familiar with (e.g., CAD solutions) while still allowing their drawings to be automatically converted to PDFs (when the drawings are saved) and automatically stored and/or collaborated on within the web document management system. A web document management system should also be able to trigger training procedures automatically when changes to specific documents are made (e.g., SOPs).
Conclusion
It is apparent that web document management within the pharma industry in absolutely necessary and that enterprise-level web document management solutions come even more highly recommended. Enterprise-level web document management systems, when built to comply with a company's needs improve communication between departments and functioning satellites while simultaneously saving administrative time otherwise spent on the management of paper…and the Fed-Ex semis.
Notes
1. Take the purchasing department as an example. How many times has a purchasing department made purchasing errors due to the simple fact that real time information from the engineering department was not available?
2. With the pharma world revolving in the direction of global markets and harmonization (e.g., ICH Q8, Q9 and Q10) how can a pharma company risk even one information error when it comes to managing suppliers, CROs, etc?
Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information in regard to web document management for the enterprise, please feel free to contact a MasterControl representative.
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