Avoid FDA Warning Letters with 4 Document Control Best Practices

By ETQ on February 16, 2019

Incomplete records stuffed in the trash, with the signatures still showing. Blank forms issued complete with signatures. Employees shredding documents without bothering to record why and what they were destroying, even as inspectors were onsite.

These practices may sound outrageous, but the document control horror stories are all right there in the U.S. Food and Drug Administration (FDA) warning letters. Even organizations that wouldn’t dream of engaging in such obvious violations could be subject to 483 notices and warning letters if they don’t get document control right.

With that in mind, let’s take a look at 4 document control best practices to help companies avoid FDA warning letters.

1. Establish Document Control Procedures

The FDA commonly issues warning letters over lack of document control procedures. Some of the most critical items the FDA is looking for include:

  • Revision history: For any document, you need to be able to see when it was issued, when it was revised and who made which changes. That means no backdating records, which the agency has noted as a problem in the past.
  • Document recall: When a new document supersedes an old one, you better show that you’ve recalled all the old copies. That means you can expect to have problems if you have old copies of Standard Operating Protocols (SOPs) taped up next to a workstation.
  • Safeguards: What controls do you have in place to prevent people from deleting or altering records? Permissions need to be set up that prevent unauthorized individuals from changing key documents such as SOPs, specifications and testing methods.

2. Integrate Document Control with Quality Processes

One common citation for life sciences companies is not having written procedures, or failing to follow the procedures you do have. Part of the problem is that companies don’t effectively integrate Document Control software and procedures into their larger quality process.

Documents are essential to every process, from change management to employee training, specifications, maintenance and Risk Management. Any change or event in one of these areas should trigger an evaluation of existing documents, so that when you make an important change to an SOP, that change makes its way to employee training.

3. Protect Data Integrity

A large number of FDA enforcement actions focus on data integrity. The agency expects data to be attributable, legible, complete, an original or true copy and accurate (ALCOA). By always asking whether your document control practices meet this standard, you can proactively avoid problems.

Because your documents—and all the data they contain—will get extra scrutiny from the FDA if there’s a suspected gap in any of these areas. Essential document control practices for protecting data integrity include:

  • Retaining original records or true copies.
  • Documenting all data from every test, not just testing into compliance or cherry-picking your data from multiple tests.
  • Real-time data recording, as opposed to allowing technicians to run a test and record the result on a scrap of paper.

If you’re using an automated Quality Management System (QMS), pulling results directly from the Laboratory Information Management System (LIMS) can help protect data integrity.

4. Control Paper Records

It’s not always easy to ditch paper records, especially in a lab environment where people are very attached to their notebooks. What you don’t want to do is have paper records outside the official GMP record (and corresponding document control procedures).

Best practices for controlling paper records include:

  • Treating forms, worksheets and notebooks as controlled documents.
  • Making sure all blank forms issued are numbered and reconciled.
  • Retaining incomplete forms and recording why they were replaced.
  • Creating processes (such as a document control group) tasked with identifying unofficial notebooks, stamping notebooks for official use and inspecting pages for gaps.

Often a warning letter is not the first sign of trouble. Instead, companies have already failed at many points prior. In many cases, they didn’t respond adequately to a 483 observation handed out after an inspection.

Taking a proactive approach to document control won’t help you avoid all problems, but it’s a basic first step in demonstrating GMP compliance. Keeping electronic records in the QMS makes it easier to pull up documents and data as needed, like when you’ve got an FDA inspector in your facility.