| For some time biologics companies and laboratories | | | | Document Management Solution |
| have benefited from home-grown or off-the-shelf | | | | When searching for a web document management |
| software solutions. Blood organizations for example | | | | solution, biologics companies should also search for |
| often utilize LIMS systems and benefit from the | | | | the following features and/or benefits: |
| large-scale data management that the popular LIMS | | | | - A solution that has successfully been validated in |
| systems provide. LIMS technology in fact is so | | | | highly regulated environments (such as medical device |
| valuable that "blood professionals" wouldn't even | | | | and pharmaceutical environments) |
| dream of manually managing the data that a LIMS | | | | - A solution that has been proven to reduce |
| system currently automates. The task would simply | | | | product-to-market cycles |
| be too great, patient risk too high and the ROI far | | | | - A solution that is configurable to the needs of its |
| too meager. | | | | users |
| An Ironic Situation | | | | - A web document management solution that can |
| The irony of this situation is that | | | | provide a significant ROI |
| 1) biologics companies understand the importance of | | | | - A solution that routes documents electronically and |
| data management and process automation in their | | | | allows for electronic approval (must also comply with |
| highly regulated environments and that | | | | 21 CFR Part 11 requirements) |
| 2) biologics companies continue to manage essential | | | | - A web document management solution that is |
| documents (e.g., SOPs, attendance forms, etc.), | | | | scalable (i.e., an open-systems architecture) |
| training processes and supplier management data | | | | - A web document management solution that |
| with hard copy paper and Excel spreadsheets. Not | | | | provides surefast audit trails |
| only do these common practices slow down internal | | | | Why training automation? |
| operations, they also stifle communications between | | | | Biologics companies are required to perform in-house |
| regional, national and global networks and result in the | | | | training for their employees. All biologics companies |
| waste of certain potential for a healthier bottom line. | | | | must conduct training when changes to essential |
| Biologics companies need to recognize that web | | | | documents have been made. For these companies a |
| document management, training and supplier | | | | solution that automatically triggers training tasks (i.e., |
| management software solutions can provide the | | | | sends training tasks to employees via email) when |
| same intensity of benefits and sure ROIs that LIM | | | | essential changes are made to an SOP would provide |
| systems and other solutions have continued to | | | | the perfect technological complement to web |
| provide over time. | | | | document management software. |
| Why web document management? | | | | Why supplier management? |
| For the biologics industries--especially for | | | | In the biologics industry supplier management data |
| blood--regulations are serious business. The FDA and | | | | control is often managed with Excel spreadsheets |
| the AABB (AATB for tissue banks and EBAA for eye | | | | and vendors are often assessed by separate |
| banks) exist for the purpose of ensuring that a | | | | departments for varied purposes. Why not search |
| company's governing documents (i.e., SOPs) exist and | | | | for a solution that will automate supplier management |
| coincide with real-life company expertise, processes | | | | and allow one department (i.e., the purchasing |
| and tasks. To meet these standards a continuous | | | | department or Quality department perhaps) to |
| process of "SOP adjustments" must take place. Many | | | | assess a vendor for all the possible vendor |
| of these adjustments--often small--are iterative and | | | | requirements leaving that information accessible to all |
| conveniently conducive to automated platforms. To | | | | company departments nation- or worldwide? |
| jump ahead of their respective competition, biologics | | | | Conclusion |
| companies should actively be searching for web | | | | Although the biologics industry has grown and |
| document management solutions that will streamline | | | | developed in large measure there are still obvious |
| SOP collaboration, document revision controls and | | | | improvements and competitive advancements that |
| document reporting features with added web-based | | | | can be made in terms of quality, compliance, and |
| securities. The web document management solution | | | | financial growth. Biologics companies should consider |
| should also ideally be launched from a platform that | | | | the robust and competitive benefits of web |
| allows for the launch of training and supplier data | | | | document management, training and supplier |
| management solutions. | | | | management software solutions. |
| Additional Features and Benefits of a Solid Web | | | | |