Advantages of Web Document Management, Training, and Supplier Management Software for the Biologics Industry

For some time biologics companies and laboratories have benefited from home-grown or off-the-shelf software solutions. Blood organizations for example often utilize LIMS systems and benefit from the large-scale data management that the popular LIMS systems provide. LIMS technology in fact is so valuable that "blood professionals" wouldn't even dream of manually managing the data that a LIMS system currently automates. The task would simply be too great, patient risk too high and the ROI far too meager.

An ironic situation
The irony of this situation is that 1) biologics companies understand the importance of data management and process automation in their highly regulated environments and that 2) biologics companies continue to manage essential documents (e.g., SOPs, attendance forms, etc.), training processes and supplier management data with hard copy paper and Excel spreadsheets. Not only do these common practices slow down internal operations, they also stifle communications between regional, national and global networks and result in the waste of certain potential for a healthier bottom line. Biologics companies need to recognize that web document management, training and supplier management software solutions can provide the same intensity of benefits and sure ROIs that LIM systems and other solutions have continued to provide over time.

Why web document management?
For the biologics industries - especially for blood - regulations are serious business. The FDA and the AABB (AATB for tissue banks and EBAA for eye banks) exist for the purpose of ensuring that a company's governing documents (i.e., SOPs) exist and coincide with real-life company expertise, processes and tasks. To meet these standards a continuous process of "SOP adjustments" must take place. Many of these adjustments - often small - are iterative and conveniently conducive to automated platforms. To jump ahead of their respective competition, biologics companies should actively be searching for web document management solutions that will streamline SOP collaboration, document revision controls and document reporting features with added web-based securities. The web document management solution should also ideally be launched from a platform that allows for the launch of training and supplier data management solutions.

Additional Features and Benefits of a Solid Web Document Management Solution
When searching for a web document management solution, biologics companies should also search for the following features and/or benefits:

• A solution that has successfully been validated in highly regulated environments (such as medical device and pharmaceutical environments)
• A solution that has been proven to reduce product-to-market cycles
• A solution that is configurable to the needs of its users
• A web document management solution that can provide a significant ROI
• A solution that routes documents electronically and allows for electronic approval (must also comply with 21 CFR Part 11 requirements)
• A web document management solution that is scalable (i.e., an open-systems architecture)
• A web document management solution that provides surefast audit trails

Why training automation?
Biologics companies are required to perform in-house training for their employees. All biologics companies must conduct training when changes to essential documents have been made. For these companies a solution that automatically triggers training tasks (i.e., sends training tasks to employees via email) when essential changes are made to an SOP would provide the perfect technological complement to web document management software.

Why supplier management?
In the biologics industry supplier management data control is often managed with Excel spreadsheets and vendors are often assessed by separate departments for varied purposes. Why not search for a solution that will automate supplier management and allow one department (i.e., the purchasing department or Quality department perhaps) to assess a vendor for all the possible vendor requirements leaving that information accessible to all company departments nation- or worldwide?

Conclusion
Although the biologics industry has grown and developed in large measure there are still obvious improvements and competitive advancements that can be made in terms of quality, compliance, and financial growth. Biologics companies should consider the robust and competitive benefits of web document management, training and supplier management software solutions.

Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information in regard to web document management in the biologics sector, please feel free to contact a MasterControl representative.