What Are Good Documentation Practices (GDocP)? And Great Documentation Tips

1:30 Spectrum of Technical Writing
1:42 Audience Analysis
3:00 Types of Audiences
4:00 GDocP (Good Documentation Practices)
11:50 Tables and Graphs
14:10 Concrete and Specific Writing Style
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So what exactly are good documentation practices?
Good documentation practices, otherwise known as GDocP, is an industry-recognized technical documentation creation, maintenance, and development standard.
You can’t put it under the general best practices of technical documentation because it is a specific method of developing documentation. It follows and very specific list of standards that need to be followed by whoever’s developing the documentation. It’s widely used in the pharmaceutical industry and the medical devices industry.
When you’re publishing documentation, you need to follow the GDocP checklist requirements to meet the industry standards. Otherwise, your technical documentation will not be approved and official.
The pharmaceutical and medical device industry already has good manufacturing practices (GMP). That’s mostly because of the Current Good Manufacturing Practice (CGMP) regulations that are enforced by the FDA (Food and Drug Administration).
Additional regulations include the 21 CFR Part 11 that regulates electronic data, electronic signatures and electronic records (ESER), and CAPA (Corrective and Preventive Actions).
Similarly, you’ll find that there is also Good Clinical Practice (GCP) and Good Laboratory Practice (GLP).
All four of them, including Good Documentation Practice, Good Clinical Practice, Good Manufacturing Practice, and Good Laboratory Practice, fall under the concept of GxP in pharmaceuticals. GxP is officially a collection of regulations and quality guidelines to ensure healthcare products are safe.
Some quality management systems also include Good Storage Practice (GSP) and Good Review Practice (GRP) in the mix too.
Along with the GxP quality control concept, a regulatory agency also includes standard operating procedures (SOPs) for the organizations.
To maintain a good record, audit trails, be attributable, and complete regulatory requirements, it’s essential to have good documentation practice.
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