Technical documentation requires years of experience and expertise on the subject matter, especially if you’re working in complex fields like pharma, biologics, computer science, and other similar industries. That’s why you need to follow good documentation practices.
There’s a difference between best practices for technical writing and good documentation practices. It’s crucial to understand that difference as a technical writer because it will help you develop better technical documentation.
In any case, keep in mind that you need to understand good documentation practices to further your technical writing career.
In this article, we’ll go over what good documentation practice is, along with the factors of good documentation practices in 2021.
Let’s dive right in.
What Exactly Are Good Documentation Practices (GDP)?
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.
6 Principles of Good Documentation Practices as of 2021
The initial good documentation practice was based on ALCOA – it’s now abbreviated into the acronym, ALOCA-C. They stand for:
Each aspect covers the fundamentals of technical documentation in the healthcare industry. They should be covered when you’re developing your computer systems, record-keeping systems, logbooks, and more.
It’s crucial to follow these six principles to maintain batch records, clinical trial records, increase traceability, improve data entry systems, making healthcare issuance easier, develop laboratory notebooks, and adhere to ISO standards, among other things.
In any case, here’s what each of the six good documentation practices entails.
The first principle states that all the documentation should be immediately identifiable and attributable. That means you should immediately be able to see who created, recorded, and developed it.
Furthermore, it also includes any precautions that have been taken against the forgery and/or falsification of those details.
The second principle is mostly about having great technical writing skills and abilities. That means you should have a strong command of the sentence structure, tone, grammar, and format.
Therefore, all the stored documentation needs to be completely legible and easy to understand. The more decipherable and unobscured it is, the better.
The idea is to develop documentation for the common person. As a result, anyone who decides to read up on the documentation can easily understand all aspects of it to the point where they can relay the information forward.
It’s absolutely crucial to maintain the originality of your documentation. That means you should always have original copies of your documentation in your computer systems.
It helps improve your confidentiality and guarantees the accuracy of the documentation.
That doesn’t mean you can’t develop and use photocopies. You can still make as many photocopies and printouts as you want, but you always need to have the original in your system.
For any sort of technical documentation, it’s crucial for it to be contemporaneous. All the documentation should demonstrate contemporaneous record-keeping.
That means that all the relevant documents need to be accurately data and time-stamped when they’re created, developed, published, and updated.
As a result, you’ll have the entire history of the document design, development, testing, production, and decision-making process at your disposal. It makes all the relevant information regarding end products completely traceable. Therefore, it would be easier to audit the document, update it, and more.
Maintaining data integrity is one of the most critical aspects of technical documentation. All the processes and procedures that go into the recording, development, and storing of the documentation need to be straightforward, accurate, and precise.
They have to be designed to ensure and maximize accuracy and reliability. Usually, there are second-person checks to see if the data is accurate. It’s especially needed when there is a lot of raw data, and it needs validation.
In any case, you have to develop all your processes to maintain data integrity, maximize data reliability, and maximize the retention period.
Lastly, the final principle is to have the entirety of your process and documentation noted down. That means your maintenance and storage of all the required documentation should be complete and top-notch, such that it encompasses the entirety of your process.
To do that, you need to pay extra attention to the point of data integrity. For that, you have to keep the following points in mind.
- The data in the documentation can and must not be altered, modified, or erased once it is entered or recorded. If, in any case, you need to make any changes or delete the data, you need to get the appropriate permissions from the stakeholders.
- Every single part of the document should be secured, protected, and stored in backup data systems. It’s best to have cloud-based systems so you can access the document at any time. More importantly, you have to make sure the documentation is secure from any unwarranted access attempts.
- There’s also a need for a well-designed system for keeping a check on the login system. There shouldn’t be any shared passwords or share data system logins to avoid any issues. Furthermore, signature forging shouldn’t be possible, especially because of the FDA’s ESER regulations.
In any case, all your technical documentation should be absolutely complete, including the data, procedures, and backups, according to good documentation practices.
Good Documentation Practices Requirements
Now that you have a good idea of the principles of good documentation practices, you can look into the requirements. Generally, the requirements may change depending on the industry and may require custom calibration in some cases. However, mostly, the requirements remain the same.
In any case, here are the parts of GDocP that are applicable in all cases.
- Documentation Creation: All documentation creation should be absolutely accurate and legible. It should also be timely; that means it should be up to date with any recent updates and occasions. Most importantly, all the data used during documentation creation should be verified from all fronts.
- Documentation Review Cycles: Every document that is part of the technical documentation should be reviewed multiple times by various stakeholders. They need to be individually verified and signed by authorized personnel. If there’s any issue, the document is to be rewritten so it can go through the review cycles again.
- Documentation Maintenance: Every technical documentation needs to be maintained to stay relevant. To do that, you have to regularly review the document to make sure it’s still relevant. If it’s not, you have to update it to make sure it’s up to date. Most importantly, the updated version needs to be backed up appropriately.
- Documentation Modifications: You need to keep a record of and maintain all the audit trails, including the reasons for modifications. Furthermore, the documentation needs to have administrative controls of the modification process and the reasons behind the modifications.
Understanding and adhering to good documentation practices not only ensure you’re doing everything according to regulations but also helps you keep track of everything and do it right.
Using Good Documentation Practices in 2021
Nowadays, if you make a mistake in the documentation, you would directly receive a single line warning letter, and then you will face a penalty.
Good documentation practices help protect you from all forms of unforeseen issues. They protect your organization, personnel, and your users. Most importantly, they help you stay compliant with state and federal laws and regulations.
Using good documentation processes will reduce your compliance risk, improve data backups, and make it easy to develop technical documentation for your organization. Mix that up with some great documentation formatting examples, and you’ll end up with excellent documentation.
Make sure you have a good idea about the principles of good documentation practices and their requirements. If you use technical documentation best practices along with good documentation practices, you’ll be developing the ideal documentation for your company and product.
If you are new to technical writing and are looking to break in, we recommend taking our Technical Writing Certification Course, where you will learn fundamentals of being a technical writer, how to dominate technical writer interviews, and how to stand out as a technical writing candidate.