Author: Amber Hilfiger, Principal Consultant
Navigate FDA Good Documentation Practices and Master the Art of Paper Trails
Picture this: you’re reviewing a critical biological evaluation report, and the date reads 04/11/21. The finalization date seems simple enough, right? Maybe not. Our colleagues across the globe in Australia would interpret it as November 4, 2021, while Americans would read it as April 11, 2021. This simple example illustrates the crucial role of Good Documentation Practices (GDP) in ensuring accuracy and consistency in the medical device industry.
In this article, we will explore the essential do’s and don’ts and provide practical tips on how to formalize GDP excellence in your organization. Let’s unlock the keys to successful FDA good documentation practices together!
Good Documentation Practices Guidelines and Compliance
GDP, though not explicitly mandated by industry regulations, plays a crucial role in compliance with ISO 13485 and 21 CFR 820, where legibility and consistency of documents are required. It serves as a best practice for achieving accuracy and consistency in meeting regulatory requirements. In fact, inconsistencies and inaccuracies resulting from poor documentation are often red flags that auditors are quick to spot, potentially leading to an FDA 483 observation.
Moreover, GDP is a key element of good manufacturing practices (GMP), which require medical device companies to consistently and correctly document handwritten and electronic information. By adhering to GDP, companies can bolster the objective evidence of their compliance with GMP, ensuring that their documentation practices are robust and aligned with regulatory expectations.
Medical device manufacturers can ensure compliance with GDP requirements by
- Adhering to relevant regulations and guidelines
- Following ALCOA principles whether recorded on paper or electronically
- Providing comprehensive training to employees
- Conducting regular reviews and audits of documentation
- Using appropriate documentation tools and systems
- Engaging with qualified regulatory experts or consulting partners for guidance and support
Relevant Regulations and Guidelines
Stay up to date with the key regulations and guidelines, including
- FDA Code of Federal Regulations Title 21 (21 CFR) Part 211 current Good Manufacturing Practices
- 21 CFR Part 58 Good Laboratory Practices
- 21 CFR Part 820 Quality System Regulation
- EudraLex Volume 4 Good Manufacturing Practices
- ISO 9001-2015 for quality management systems
- ISO/IEC 17025 for laboratory testing and calibration standards
- ISO/IEC 27001 for information security management system
- ISO 14001 for environmental management
- ISO 13485:2016 for medical device manufacturing
Follow ALCOA and Expert Guidance
ALCOA is an acronym that stands for Attributable, Legible, Contemporaneous, Original, and Accurate, which are key elements of good documentation practices. These principles emphasize the importance of documenting information that is traceable to its author, clear and readable, recorded in real-time, in its original form, and accurate. These principles align with FDA GDP requirements and are used as a framework for ensuring compliance with documentation practices in medical device manufacturing.
To adhere to ALCOA and achieve documentation excellence, consider the practical knowledge and expert tips below.
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
Here 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, we’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.
Select Appropriate Document Management Systems
Eliminate paper and look for flexible, digital document management systems (DMS). Starting your med tech development journey with one of these may be the key to efficiently and consistently meeting a wide range of GxP requirements for your business while minimizing costs in the long run.
The top 10 DMS features to look for:
Document control: Look for version control, revision history, and document approval workflows. This allows for proper management of documents throughout their lifecycle, ensuring that the latest approved version is always accessible and in use.
Electronic signatures: The DMS should support electronic signatures in accordance with regulatory requirements, such as FDA 21 CFR Part 11. This allows for secure and compliant signing of documents, eliminating the need for physical signatures and streamlining the review and approval process.
Access control: Look for capabilities that allow for different levels of access and permissions based on user roles and responsibilities. This ensures that only authorized personnel can view, edit, or approve documents, maintaining data integrity and security.
Search and retrieval: The DMS should allow users to quickly locate and retrieve documents based on metadata, keywords, or other criteria. This helps to streamline document retrieval and ensure that the correct version of a document is being used.
Collaboration and workflow: The DMS should facilitate collaboration among team members, allowing for real-time editing, commenting, and feedback on documents. Additionally, the DMS should support workflow management, enabling the creation and management of document review and approval workflows to ensure timely and efficient document processing.
Audit trails and reporting: Look for capabilities that generate audit trails and provide comprehensive reporting to track document changes, approvals, and user activities. This helps with regulatory compliance, internal audits, and quality management.
Integration: The DMS should be able to integrate with other systems used in your medical device manufacturing process, such as quality management systems (QMS), enterprise resource planning (ERP) systems, and electronic document submission platforms, to streamline processes and ensure data consistency.
Security and compliance: Look for security measures, including encryption, access controls, and data backups, to protect sensitive documents and ensure compliance with relevant regulations, such as GDPR, HIPAA, and FDA regulations.
Scalability and flexibility: The DMS should grow and adapt with your business. Look for capabilities that accommodate the addition of new documents, users, and functionalities as the organization evolves.
User-friendly interface: Look for a user-friendly interface that is easy to navigate and use, with intuitive features and functionalities, to promote user adoption and ensure efficient document management processes.
Several DMS options exist. Take the time to assess the various systems and start this process early so you can establish GDP as early as possible.
We can assist in your selection and implementation of an appropriate eQMS or set up a manual system and establish a purpose-built medical device document control system for you.
Lean Into Our GDP Best Practices
Consistent and accurate record-keeping is critical to a functioning quality management system (QMS), and FDA 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.
“What I appreciated is the breadth of services that QA Consulting, Inc. provided, including expertise with Grand Avenue Software. They offered quick and efficient QMS SOPs, and were pleasant to work with.”
– Diane Keyser, Sr. Quality Engineering Consultant
