Document management is such a fundamental need in any FDA compliance effort, and it poses so many challenges, that we could easily discuss the top 20 or more problems that plague life science companies. But in the interest of space, here are the top five document control issues that most companies complain about and some tips on solving them.
1. Inefficient Routing and Tracking. Sure, walking is healthy, but legwork as a means of routing and tracking documents critical to FDA compliance is simply inefficient. Imagine a sprawling manufacturing site with several buildings that house hundreds of people who work different shifts 24/7. Routing a document change request form, for example, would mean walking from one building to another in a race against the clock to catch a certain person during his or her shift. Tracking the form would require twice the effort. Granting that this form can be routed via e-mail, the possibility that it might get buried in someone's "in" box remains.
Document Management Solution: Automation is the best solution for this common problem. Whether your employees are in different buildings or in different countries, routing will be done electronically, so location and distance would cease to be a stumbling block. A Web-based document management system would be ideal for companies with employees scattered across the country or around the world. Look for an electronic document management system with robust tracking feature that will show you when a document was sent and to whom, and also identify bottlenecks. It should show the document's history, including who has approved it and when, or who has rejected it and why.
2. Lack of Mechanism for Escalation. It's inevitable ? there will be one or two people, out of a dozen or so reviewers and approvers of a document change, who will be out of the office when you need them most. For days, the initiator of the document change may not even know that these people are out, perhaps on vacation, or attending an out-of-state conference. Without any formal means of escalation, the process bogs down.
Document Management Solution: A Web-based document management solution could easily remedy this problem. After a period of inaction on the part of the employee on vacation, the document will escalate to the next person in line to review or approve it. Meanwhile, the person who's attending an out-of-state conference could still participate in the process via the Internet. With an electronic document management system, the document approval process need not be at a standstill every time a reviewer or approver is unavailable.
3. Ineffective Revision Control. No, it isn't a case of déjà vu when you keep seeing an obsolete SOP that you have disposed of a long time ago. It's simply ineffective revision control. This is a common problem for companies with paper-based document management systems. Another common issue is the release of unapproved documents since there is no mechanism to stop anybody from inadvertently using draft procedures, SOPs, and other documents that have not yet been approved.
Document Management Solution: Choose a Web-based document management system with an FDA-compliant revision control feature that will automatically archive obsolete documents. It should be able to lock a document while it is being revised, so there is no danger of employees making the mistake of using unapproved documents. Only authorized, current versions will be available to users. Moreover, a robust revision control feature means the system will be able to track down any changes to documents and make them available through reports.
4. Lack of Secure, Centralized Repository. In this Age of High-Tech, many companies continue to rely on filing cabinets or basic database systems to store critical information. They usually create documents using Microsoft Word and then store the hard copy in binders, or maintain the files in electronic folders and directories. The problem with either a paper-based or a partially electronic system is that it's not secure, and it's easy to lose files, sometimes without any means to recreate them. For companies with facilities in different cities or countries, this also means records are scattered in different places. In this scenario, it is not only difficult to find and access documents, but it is doubly hard to update them if they are not readily available.
Document Management Solution: When automating your document management system, go beyond a simple database management tool and choose a solution that offers FDA-compliant security features. If your company uses electronic records to comply with predicate rules, keep in mind that 21 CFR 11 requires that access must be limited to authorized users, and policies must be established to hold users accountable for actions initiated under their electronic signatures. A Web-based document management solution will solve the problem of access to a centralized repository for employees in scattered locations.
5. Inefficient Process for Obtaining Signatures. FDA regulations almost always require accountability, and consequently, a signature of the person(s) responsible for a certain process, or a change, for example. The challenge in obtaining signatures is similar to the problem of manual routing. Users must literally chase an approver for his or her signature. If there are only two approvers and only a few documents that need to be approved every now and then, this is not an issue. But multiply the number of documents that need to be signed with the number of approvers and the number of facilities involved in the approval process, and you get the picture of how serious a challenge one little autograph could mean.
Document Management Solution: If you need signatures, routing Microsoft Word documents via e-mail ceases to be an option. An electronic document management system with FDA-compliant electronic signature capability is what you need. Choose a solution that provides e-signature manifestation that can be configured to include a user's name and title and the route step name. This will help distinguish the different kinds of approval (i.e., format approval made by a document control specialist vs. procedure approval made by the quality director) that each document or packet receives, a critical factor in the FDA environment.
Learn More About 21 CFR Part 11 A predicate rule is any FDA regulation that requires companies to maintain certain records and submit information to the agency as part of compliance. Examples can be found in in GxP regulations such as GLP (Good Laboratory Practices), GCP (Good