Document control issues are among the most commonly cited observations in FDA Form 483s and warning letters. In the medical device sector alone, document control-related issues represented 10 percent of Form 483 observations and 8 percent of warning letters in 2014(1).
|Most organizations that use a paper-based
or a partially electronic system stumble
over these nine common document control issues.
Document control refers to procedures for approval, distribution, and change of a document and the designation of a person or people to implement those procedures. It is a basic requirement fulfilled by one person in some companies and a full-scale department in others. While companies vary, for most of them, document control spans the following stages:
- Document Creation
- Change Control
Let’s take a look at some common issues in each stage, as well as tips on how to avoid the problems.
Stage 1: Document Creation
Pitfall #1: Collaboration is time consuming. Document creation almost always requires collaboration, which could be time consuming without the appropriate tools and an effective system.
Organizations that use paper-based document control systems typically collaborate by gathering key personalities in one room or they route a document via email. A system with virtual collaboration workspace is key in facilitating collaboration. Team members can add their input in a secure and real-time environment. A cloud-based system will allow access for authorized users 24 hours a day from virtually anywhere, so physical location will no longer cause delays in document creation and collaboration.
Stage 2: Document Approval and Distribution
Pitfall #2: Delays can make the process grind to a halt. This happens if the process relies on the presence of approvers and it doesn’t provide a mechanism to handle their absence.
Pitfall #3: Ghost of revisions past haunts users. This happens when old revisions are uncontrolled and continue to surface.
Pitfall #4: Training can fall through the cracks. This happens if a document is approved, but it doesn’t trigger the necessary training for affected employees on the document.
Companies cut down their review and approval turnaround time significantly after automating their document control process. Routing, follow-up, escalation, and distribution are all automatic, saving time and effort. Where companies usually run into trouble in the distribution of new revisions is not knowing where all the copies of the old revision are. Having a system that allows you to lock down uncontrolled copies and facilitates tracking of controlled copies will solve this problem. Integrating document control with your learning management system ensures that training tasks related to document changes will not fall through the cracks.
Stage 3: Review and Change Control
Pitfall #5: Document review can be neglected. This happens if the process fails to integrate a regular review to ensure that a document is still applicable.
Pitfall #6: Ensuring the right people are involved in every change is a big challenge. This happens if the process doesn’t connect all the stakeholders.
Pitfall #7: Product iteration information relies heavily on “tribal knowledge.” Documents should have a traceable history that will be accessible long after the original team members have moved on.
In many industries, developing a successful product requires many iterations, which makes change control crucial. It’s also a compelling reason to automate your document control and change control process. With an electronic system, you can route different types of changes to the appropriate group of people so the change control process is both efficient and thorough. A centralized repository for all product documents will allow your organization to revisit the relevant documentation long after a product has been launched.
Stage 4: Retrieval
Pitfall #8: Finding a document is like looking for a needle in a haystack. Approved documents must be easy to find and reference. Otherwise they are of little use.
Many people are accustomed to searching for information by typing in the terms they are searching for. Sometimes it is more efficient to browse an organized hierarchical structure. In either case, associating the proper metadata to the document as well as supporting full text searching are critical elements to enable your organization to quickly find the needle in the haystack.
Stage 5: Obsolescence
Pitfall #9: Document retention can be ineffective. This happens if a well-designed retention policy is not put in place and enforced.
There can be issues with keeping documents for too long as well as too short. Regulatory requirements will dictate a company’s retention timeframes. You should also use a risk-based approach to determine reasonable document retention times for various types of documents.
The problems mentioned above are worse in organizations that use a paper-based system or a partially electronic system. If your company faces this situation, switching to a fully automated system will be a significant step toward improving your experience and ensuring compliance.
If document control is your most pressing problem, find an out-of-the-box tool that will help you transition to an electronic system fast. Look for a solution that’s part of an enterprise platform so you will be able to add modules in the future. An enterprise platform can integrate document control with other quality processes and connect the different teams managing those processes for a more holistic approach to compliance.
This article is based on a white paper, 9 Pitfalls to Avoid During the Document Control Process.
View a slide presentation based on this white paper.
Dave Hunter joined MasterControl in 2002. His extensive technology experience includes working for Microsoft, EDS, Intel, and TenFold for over 20 years. He received his bachelor’s degree in electrical engineering and his MBA from Brigham Young University.
(1) The 483 observations and warning letter citations are related to document control subsystem as defined under the Quality System Regulation. The requirements can be found in 21 CFR Parts 820.40, 820.180, 820.181, 820.186, and 820.184.
From “2014 Annual FDA Medical Device Quality System Data,” presented by the Center of Devices and Radiological Health (CDRH), FDA website,