Author: Amber Hilfiger, Director of Operations and Sr. Consultant
If your biological evaluation report is dated 04/11/21, on what date was the document finalized?
Americans would say April 11, 2021. However, our friends down under in Australia would say that’s November 4, 2021.
This is a classic example of a good documentation practice (GDP) “don’t”. If people in different geographic locations would read the date of critical information differently, it’s ripe for misinterpretation.
The purpose of good documentation practices is to ensure your documentation can’t be misinterpreted.
Consistency and accuracy in how your organization documents information is critical.
Read on to learn more about:
- Where GDP fits into compliance with industry certifications
- Top GDP Do’s and Don’ts
- Tips to help your team follow GDP
Good Documentation Practices and Compliance
While there is no industry requirement to follow GDP, ISO 13485 and 21 CFR 820 require documents to be legible, among other things. GDP is a best practice on how to achieve legibility and consistency to requirements. Inconsistencies and inaccuracies resulting from poor documentation are red flags that an auditor is likely to notice. Such errors may result in an FDA 483 observation.
Also, GDP is an element of good manufacturing practices (GMP). Medical device companies that adhere to GMP must document information consistently, correctly, and well. GDP can help strengthen objective evidence of GMP.
Medical Device Good Documentation Practices Do’s and Don’ts
Here are the hallmarks of good documentation practices:
- Initial and date all entries
- A timeline of regular reviews
- Content is legible and entered using permanent ink
- Corrections and updates allow for original information to be readable
- Data inputs adhere to ASTM E29 standard for rounding
Following are some of the most common don’ts that we see:
- Back-dated entries
- Overwrite previous entries (correction fluid a no-no)
- Record the data before the action or event has occurred
Download our internal technical document as an example of Good Documentation Practices.
Formalize GDP Training for Your Employees
While many medical device manufacturers have a company-wide GDP policy, I’ve found that many lack a formal training process to ensure employees follow it. An employee may receive an overview when they first start a job, but it’s rarely mentioned after that.
Here are QA’s recommendations to formalize good documentation practices at your workplace:
- Host an annual training session.
- Post your GDP policy (including the Do’s and Don’ts) online where employees can easily reference it.
- Maintain a signature log to record your employees handwriting, and don’t forget to record their initials, too!
- Hold your team accountable for violations instead of waiting for an auditor to find them.
Lean Into Our GDP Best Practices
Consistent and accurate record-keeping is critical to a functioning quality management system (QMS), and good documentation practices (GDP) can easily be overlooked.
Engaging a medical device quality consulting partner with the experience to help you select document control software and implement a process that’s right for your organization can be the missing piece that helps you reach your quality and compliance goals more efficiently.