If your company must follow FDA guidelines, then you know how important it is to utilize document control management. When many of your work processes are regulated and audited, you need to make sure you can prove your compliance quickly and easily. While there are many aspects of a document management system that can help you remain compliant, one feature that is imperative to document management is version control.
What Is Version Control?
Put simply, version control makes sure that your company is looking at the most up-to-date version of a document. However, the capabilities of version control go much deeper. With version control, you will be able to:
• Track and manage the changes made to each document
• Ensure that content cannot be accessed by unauthorized users
• Get notified if there are pending updates that are awaiting approval
• View the most current content and know who reviewed/approved it and when
• Respond to external audits with history reports
How Version Control Helps with FDA Compliance
As you can see, there are many opportunities for compliance with the help of version and change control. Here are more specific examples of FDA regulations that can be met with the right version control document management system:
• 11.10a – This regulation states that you need to be able to validate that your records are accurate, reliable, and consistent, and that you can demonstrate which records have been altered or invalidated. With version control, every change is documented, so approvals, edits, and deletions are all time-stamped with the user’s name.
• 11.10c – With this guideline, all records must be protected from unauthorized users and they must be easily accessible. With version control, every document is only available to the users you specify, and it is simple to retrieve using the document control management search feature.
• 11.10e – This is the regulation that requires every document to be auditable and stored on a secure platform. With document control from our document management system, every edit will contain a time stamp, and the document will be protected by whatever security measures you identify. You can mark a completed document as “read-only” while still maintaining a complete audit trail.
• 11.10k – For this regulation, you must have control over who has access to documentation and you must have change control procedures in place that show the time-sequenced updates of each document. Version control helps you meet both requirements with ease.
As you can see, FDA compliance often relies on the ability to control who can access documents and the ability to keep a detailed record of who makes changes. With version control being a core competency of our document management system, these issues are never a concern. It is effortless to monitor the history of every document so that when you do get audited, you can be confident in your compliance. To learn more about our document control management software, contact us now.