According to the FDA, six words not to utter on FDA inspection day are: “Now, where is that darn document?” (It’s nice the FDA has a sense of humor, at least on paper).
Kidding aside, this is a big-enough issue that the FDA recently offered a seminar to alleviate problems such as:
- Unscanned paper documents
- Confusing naming conventions
- E-mails as documentation
- Non-functional or non-existent SOPs
- Missing documents
So if you are somewhat dysfunctional when it comes to data retrieval, desire better SOPs for electronic document management, or just want to tackle one more New Year’s resolution, check out what Govardhan Muralidhar, industry solutions manager for Pilgrim Software, has to say about document management.
What are FDA expectations when it comes to document management?
Govardhan: There are quite a few. The FDA wants only current and approved documents to be accessible to employees. Involved personnel need to be notified when a new document/ SOP is released and adequately trained on each document revision. A training matrix or training history should also be maintained for these staff in order to display training history on a document.
The FDA expects documents to be reviewed on a regular basis (annual or biannual) to make sure they are still relevant to current business processes (effectiveness review).
Documents need to be retained for an appropriate length of time, which may vary based on the type of document. Also new documents or documents being revised should go through a change control workflow to ensure that changes being implemented are valid.
What are the biggest problems for medical device companies when it comes to document management?
There are three common pain points:
- Document-based training. This includes notification that a document is ready for training and then tracking each employee’s training completion/signoff. This becomes more difficult as the number of documents and employees increase as a company grows or introduces new products.
- Impact analysis for changes. When using a manual system, it is difficult to understand exactly which documents are affected by a change made to another document.
- Document search and retrieval is more difficult in a manual or network system. An electronic document management system provides more ways to organize and search for documents easily. For example, using dashboards and repositories can eliminate searching by showing users the documents they need to work with or that need their attention. Repositories allow the documents to be categorized and stored and provide easier access to end user.
- Periodic review of documents to review design specs, work instructions, SOPs, forms, etc. cannot be performed effectively. One has to remember when to review the document for its accuracy and find the document before it expires.
Do a lot of companies still rely on paper copies in a manual system?
Some companies do rely on paper copies, manual filing, etc. It is also common to see companies storing their documents on a network drive, typically categorized by type or department. These documents are more difficult to control in terms of updating new revisions and ensuring that users are working with the current document version. Training and approvals on documents are typically tracked in an Excel spreadsheet using this type of setup, which can be cumbersome to maintain. And it becomes a nightmare if the same document is stored in multiple folders and it gets changed. All the folders have to be scanned to find multiple instances of the document to take appropriate actions.
If a company thinks it’s really doing a good job with document management, what is it probably missing?
If a company has a manual system and thinks it is doing a good job, they probably are. The requirements are fairly straightforward. However, they are probably doing a lot of non-value added work to maintain a manual document management system. An electronic system will save them time and allow employees to focus on other tasks, instead of following up on pending approvals or training needs, manually updating training records, manually updating the newest document version, manually creating document master lists or training reports, etc.
They may also want to consider their plans for growth. If they are planning to hire a significant number of employees, introduce a new product, or add a new facility, the time needed to manually manage documents will grow very quickly. A manual system that is working now may be too difficult to manage a year from now.
The best way to manage documents is electronically—what benefits can be expected when a high-quality document management system is in place?
A document management system will achieve all the improvements mentioned above. The document management system will be able to integrate with other solutions and provide access to approved, controlled documents in other areas of the quality and regulatory system (CAPA, audit, etc.). Ultimately the most significant benefits come in the areas of reduced cycle time for approvals, collaboration, more accurate training notifications and reporting, streamlined periodic review, and improved change control.
Pilgrim Software’s document management solution integrates document management into your value chain—it provides creation, versioning, approval, change control, training, and periodic review processes in a single tool, providing a solid document management framework to meet industry and regulatory requirements. For more information, visit http://www.pilgrimsoftware.com/