6 Document Control Best Practices for FDA and CGMP Compliance

6 Document Control Best Practices for FDA and CGMP Compliance
August 12, 2019 seouser
document control

For companies regulated by the Food and Drug Administration (FDA) and Current Good Manufacturing Practices (CGMP), non-compliance can be costly.

Too often, simple problems with managing documentation are at fault.

Here we consider key document control best practices, for ensuring FDA and CGMP compliance.

Common reasons for FDA warning letters

Consider some examples of recent FDA warning letters, issued after inspections of various companies’ document control measures:

  • failure to maintain data – this firm lacked complete data from laboratory analyses
  • improper documentation – retests were done without documentation to justify it and only final test results were kept
  • inability to retrieve data – test data was requested but managers were unable to present it to inspectors
  • incomplete audit trail – in this case, some changes were not reflected in the audit trail
  • data files in the recycle bin – inspectors discovered important data files in the computer’s recycle bin.

These examples point to some of the common document control failures that lead to compliance issues. Help your business avoid making the same mistakes!

6 best practices for document control compliance

Implementing and adhering to strict document control practices will ensure your company is never caught short in the event of an FDA inspection.

1. Establish comprehensive document control procedures

The first step is to implement document control standard procedures that are understood, accepted and practised throughout the organization without fail.

Lack of SOP when it comes to document control leads to oversights and potentially, FDA and CGMP compliance issues.

2. Develop workflows for all document types

An overall document control system that applies to all documents is required.

However, specific types of documents will require differences in workflows as they will be reviewed or approved by different people within the organization.

3. Use a system that integrates with Microsoft Office apps

Most documents in any business are created using well-known programs such as Word, Excel and PowerPoint.

It makes sense to use a system that works well or is compatible with these programs.

4. Don’t overlook metadata configuration

Metadata refers to high-level information related to the document such as department head, priority level, ISO requirements, author and so on.

This data is necessary when it comes to categorizing, reporting, searching and filtering documents which will be important during an inspection.

5. Protect data integrity

Data integrity should be a high priority when it comes to document control. The FDA expects all data to be attributable, legible, complete, original and accurate (ALCOA).

Examples include real-time data recording and retaining original or true copies of documents.

6. Integrate document control with other quality management systems

Document control is part of a larger quality management system.

Ensure that your document control procedures integrate with the rest of the system and don’t contradict it in any way. QMS software can help with this.

Document control software from isoTracker

isoTracker offers modular, cloud-based quality management software including document control software. The Document Control module provides automated version control, approval workflow, restrictive access, review reminders, archiving and full audit history.

This software can stand alone or integrate seamlessly with other isoTracker quality management modules.

Contact us to learn more or to get advice on how document control software can help your business comply with FDA and CMPG regulations on documentation.

Get a free trial now