Good documentation practices -- GDocP -- are an official documentation creation and maintenance standard.
Not to be confused with general best practices for writing documentation, GDocP is a specific term that includes a list of standards by which documentation in the pharmaceutical and medical device industries must adhere.
If you’re publishing documentation in either of those industries, GDocP is the checklist of requirements those documents must follow in order to meet industry documentation standards.
What’s the Point of GDocP?
In medical device and pharmaceutical manufacturing, GDocP is essential to maintaining the highest quality and consistency in documentation across the two industries.
Quite simply, the ultimate point of GDocP is that it protects the end-users. By establishing high standards for the documentation, it raises the standards of the associated products. Standards are important in ensuring that everyone in an industry is playing by the same rules and that their adherence to those rules can be confirmed. Think of it like soccer; the world follows the same rules of soccer so there isn’t international confusion on the pitch. Similarly, GDocP makes sure that any documents made in the pharma and medical device industries follow the same guidelines, workflows, and production standards. This way, documentation isn’t recalled or questioned because it follows the GDocP standards.
Reduces Risk & Assuages (Some) Audit Anxiety
In high-risk industries like pharmaceuticals and medical devices, being out of compliance isn’t an option. This applies to physical products as well as supporting documentation. Good documentation practices, being standardized, keep documents compliant to match their respective products.
A medical device industry survey reported the following finding:
3 out of 4 medical device professionals reported that they weren’t confident they’d pass an unannounced audit by the FDA or Notified Bodies.
That’s a scary number. There’s no industry where the word audit doesn’t cause a little anxiety, but pharma and medical device manufacturers have a wide array of regulatory bodies and standards with which to comply. Everything from the Food and Drug Administration (FDA) or the Therapeutic Goods Administration (TGA), to best practice standards such as Good Manufacturing Practices (GMP) or Good Pharmacovigilance Practice (GVP). The reality is that for medical device and pharma companies, there are innumerable regulatory bodies who routinely exercise the right to drop in on them -- often unannounced -- to put their compliance to the test.
Again, audits are necessary, and GDocP will have your documentation beyond questioning. Knowing the processes and expectations outlined by GDocP will help take a little bit of that audit anxiety away. In a way, the process acts as an audit failsafe. While audits are annoyingly necessary, GDocP gives you the tools to have your documentation ship watertight before the audit storms hit.
You’ll Need It for Most Industry Certifications
As far as industry compliance is concerned, both pharma and medical device manufacturing answers to the International Organization for Standardization (ISO). Among the many certifications from the ISO, good documentation practices are required to meet several of them. Two, in particular, stand out.
GDocP for ISO-9001-2015:
This is a general group of requirements for quality management systems for organizations that:
- Need to deliver products and services that consistently meet compliance requirements and customer expectations.
- Plan to enhance customer satisfaction through the successful application of their quality management system.
GDocP for ISO 13485:2016:
This applies specifically to the medical device industry and provides targeted groups of requirements for quality management systems for those organizations to consistently meet compliance requirements and customer expectations. This even goes so far as to impact outside organizations that are, in any way, a part of the production lifecycle of medical devices.
What Does My GDocP Require?
It depends per industry but generally applies to the content you create for your product and the workflows used to create that content.
There are, of course, different certifications for every industry pursuing good documentation practices. Broadly speaking, the universally applicable parts of GDocP look like this:
- Documentation Creation:
- Must be accurate
- Must be timely
- Must be verified
- Must be legible
- Documentation Review Cycles:
- Must be verified and signed by authorized personnel
- Documentation Maintenance:
- Must be regularly reviewed
- Must be up to date
- Must be backed up appropriately
- Documentation Modifications:
- Must maintain audit trails
- Must include reasons for modification
- Must contain administrative controls over who can modify documents
- Must contain administrative controls over why documents can be modified
Good Documentation Practices Are Here to Protect You
GDocP is a valuable ally to have for documentation compliance.
To pull the plain truth out of a jungle of acronyms, standardization nomenclature, and buzzword proliferation, it boils down to this:
Good documentation practices protect your users, your organization and personnel, and you from errors that might occur if GDocP standards weren’t there.
If you want to get your documentation audit-ready, take a look at Heretto. We’ve helped leading organizations within medical industries speed up their documentation process, improve overall quality, and reduce exposure to compliance risk. If you feel lost in the fog of GDocP, Heretto is here to light the way.
