Is Your Company Making These Common Documentation Mistakes?

How effective is your company’s documentation process? Good Documentation Practices (GDP) are essential in the medical device, pharmaceutical, and biotechnology industries.

The Food and Drug Administration (FDA) requires all companies to ensure data integrity through every step of the process. The expectation is that all data is complete, consistent, and accurate.

The overall belief is that if something hasn’t been documented, it hasn’t happened. This is the general approach that you should take as well. 

One way to ensure FDA-compliant documentation is to follow the ALCOA principle. ALCOA stands for:

• Attributable
• Legible
• Contemporaneous
• Original
• Accurate

These guidelines are essential if you want your documentation process to satisfy the FDA’s requirements.

How Does the FDA Enforce GDP?

The FDA uses several methods to enforce data integrity, including:

• Import alerts
• Warning letters
• Regulatory meetings
• Consent decrees
• Seizures
• Untitled letters
• Injunctions

We recommend you review the “Data Integrity and Compliance With CGMP Guidance for Industry” for a detailed breakdown of how the FDA approaches data integrity and Current Good Manufacturing Practices.

Many companies still make documentation mistakes due to the complex nature of FDA guidelines. We’ve compiled a list of documentation mistakes that we feel your organization should be aware of.

A Few Common Documentation Mistakes to Consider

• Obscuring the original entry with a change. All changes must be legible and not obscure the original entry.
• Overwriting to ensure accuracy. The FDA prioritizes accuracy, but overwriting doesn’t guarantee accuracy. Keep your documentation succinct and to the point.
• Using pencils. Pencils are an unacceptable writing tool because they are erasable. The FDA requires all entries to be made using an indelible writing tool.
• Misusing error codes. There are several error codes that you will need to learn for CGMP documentation. These error codes are necessary for denoting specific mistakes during various stages in your documentation.
• Illegible writing. The data you record is important and needs to be legible. Something as simple as poorly writing the number “4” can cause confusion. Ensure that your writing clearly states your intentions.

Are Your Documentation Practices FDA-Compliant?

The Center for Professional Innovation and Education (CfPIE) provides training and certifications to companies in the medical device, pharmaceutical, and biotechnology industries.

Our technical writing and documentation courses are designed to help your company create FDA-compliant documentation processes.

Here are just a few of the courses and certification programs we offer:

• Effective Document Management for Pharma, Biotech, & Medical Device
• Become a Document Management Certified Professional (DMCP)
• Become a Certified Medical Writing Professional (CMWP)