Web Document Management and "The Rest" for Small and Mid-Sized Pharmaceutical Companies
Marci L. Crane
February 14, 2009
Pharmaceutical companies are--in many cases--becoming technologically savvy. Short-span patent lives and shrinking "jackpots" are forcing pharmaceutical executives to take a second (or a third) look at philosophies associated with lean manufacturing, Six Sigma and the ICH Q10 guidelines recently published for purposes of harmonization between the US, UK and Japan, as well as between other countries where pharmaceutical manufacturing or outsourcing is likely to take place.
The Beginning
Pharmaceutical companies will find it difficult to implement recommended--and proven--strategies for clean and lean manufacturing, not to mention streamlined technology transfers between development and manufacturing stages, if they continue to address only GMPs without considering a product's entire lifecyle. Real progress can be made toward an environment that is streamlined, connected and in touch with the latest and greatest knowledge on lean manufacturing and Six Sigma practices. However, this progress requires the right technology but the question remains: Where do we start? For small and mid-sized pharmaceutical companies this question is especially pertinent since the decision to invest in technology could "make or break" potential business in a fluctuating economy.
Start with Web Document Management
If a small or mid-sized pharmaceutical company wants to eventually streamline quality, regulatory and business process controls with an integrated quality management or product lifecycle management system but don't have the funds to do it now, they should consider starting with an off-the-shelf web document management solution that allows professionals to access web-based, centralized document management and document control. After all, documentation is at the heart of all quality, regulatory and business process solutions.
What it Should Offer
The web document management solution should, of course, provide Part-11 required protections and verification patterns and should also provide powerful version controls and reporting features. The solution should also allow for worldwide collaboration (to collaborate with outsourcers, additional colleagues, etc.) and should easily be integrated with a learning management system as funds become more readily available.
A Solid Return on Investment
A web document management solution, at the right price, is a solid ROI opportunity. After all, it inevitably cuts back on tedious administrative work and eliminates the frustration of lost documents, manually routed documents, filed documents, etc. Who wants the liability of hard-copy documents when completely built-in digital audit trails are available with reasonably priced web document management solutions. It is with this type of web document management solution that pharmaceutical quality and regulatory professionals (as well as anyone else who has rights to the solution) can access the whos, whens, whats and wheres that seem like they are always needed at the spur of the moment.
Just imagine how easy audits are with a simple document management and learning management solution combo.
Most Important!
Most important of all, pharmaceutical companies should remember to choose a web document management system that can essentially be "rolled out" into a full scale quality or product lifecycle management system. That way, mergers and sudden bursts of growth won't leave entire companies lost in processes and with documentation gone awry.
Other Considerations
Other considerations that are valuable to contemplate when purchasing a web document management solution are listed as follows:
Conclusion
It's inevitable that pharmaceutical companies will have to "go electronic" in almost every aspect of their business. Why not start with something simple? Why not start with web document management?
Marci Crane is a marketing communication specialist at MasterControl in Salt Lake City, Utah. For more information in regard to web document management, please feel free to learn more about MasterControl's GCPDocs Express solution, designed especially for the needs of growing pharmaceutical companies. To make additional queries, please feel free to contact a MasterControl representative.
The Beginning
Pharmaceutical companies will find it difficult to implement recommended--and proven--strategies for clean and lean manufacturing, not to mention streamlined technology transfers between development and manufacturing stages, if they continue to address only GMPs without considering a product's entire lifecyle. Real progress can be made toward an environment that is streamlined, connected and in touch with the latest and greatest knowledge on lean manufacturing and Six Sigma practices. However, this progress requires the right technology but the question remains: Where do we start? For small and mid-sized pharmaceutical companies this question is especially pertinent since the decision to invest in technology could "make or break" potential business in a fluctuating economy.
Start with Web Document Management
If a small or mid-sized pharmaceutical company wants to eventually streamline quality, regulatory and business process controls with an integrated quality management or product lifecycle management system but don't have the funds to do it now, they should consider starting with an off-the-shelf web document management solution that allows professionals to access web-based, centralized document management and document control. After all, documentation is at the heart of all quality, regulatory and business process solutions.
What it Should Offer
The web document management solution should, of course, provide Part-11 required protections and verification patterns and should also provide powerful version controls and reporting features. The solution should also allow for worldwide collaboration (to collaborate with outsourcers, additional colleagues, etc.) and should easily be integrated with a learning management system as funds become more readily available.
A Solid Return on Investment
A web document management solution, at the right price, is a solid ROI opportunity. After all, it inevitably cuts back on tedious administrative work and eliminates the frustration of lost documents, manually routed documents, filed documents, etc. Who wants the liability of hard-copy documents when completely built-in digital audit trails are available with reasonably priced web document management solutions. It is with this type of web document management solution that pharmaceutical quality and regulatory professionals (as well as anyone else who has rights to the solution) can access the whos, whens, whats and wheres that seem like they are always needed at the spur of the moment.
Just imagine how easy audits are with a simple document management and learning management solution combo.
Most Important!
Most important of all, pharmaceutical companies should remember to choose a web document management system that can essentially be "rolled out" into a full scale quality or product lifecycle management system. That way, mergers and sudden bursts of growth won't leave entire companies lost in processes and with documentation gone awry.
Other Considerations
Other considerations that are valuable to contemplate when purchasing a web document management solution are listed as follows:
- The web document management solution provides email notification and real-time escalation of document approvals, etc.;
- It can be rolled out into an enterprise solution;
- Can be hosted or brought in-house as your company prefers;
- Allows for the serial or parallel routing of documents;
- Allows for the scanning and uploading of legacy; documents/records to the centralized document archive;
- Fits your company's IT model and URS (user requirement specifications);
- Allows users to see where a document is at any point during the routing process;
- Allows users to set up notifications throughout the document routing process;
- Allows users to utilize the solution via the applications users are already familiar with such as MS Word, Outlook and SharePoint;
Conclusion
It's inevitable that pharmaceutical companies will have to "go electronic" in almost every aspect of their business. Why not start with something simple? Why not start with web document management?
Marci Crane is a marketing communication specialist at MasterControl in Salt Lake City, Utah. For more information in regard to web document management, please feel free to learn more about MasterControl's GCPDocs Express solution, designed especially for the needs of growing pharmaceutical companies. To make additional queries, please feel free to contact a MasterControl representative.
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