Whether it is an SOP or a test report, there are certain practices that everyone should follow in order to create a document that fits properly in an organization’s quality management system. Some of these practices are simpler, such as legibility, while others, like data integrity, are more complex. Regardless, all the practices should be followed in order for an organization to truly follow Good Documentation Practices (GDP).

One of the first key components of GDP is data accuracy and data integrity. Data should be recorded as accurately as possible. That accuracy should be checked and verified by someone who did not originally record it. The data should be recorded in real-time in order to assure its validity. This would include the date and, in some cases, timestamps. Recording both would allow for greater traceability of the data as well as the document as a whole. In addition, the data should not easily be changed. Any change made to the record should be tracked via a change control process.

Another key component touched on briefly already is traceability. Documents should be easily identifiable and traceable. Meaning that the person who originally wrote the document should be easily known when looking at the document.  The document should be easily located when needed as well. The documents that are related to each other should also be easily identifiable. Meaning that it should be obvious which documents go together.

A document control system that is built into the quality management system will help maintain proper Good Documentation Practices. The system will help with the creation of new SOPs and maintain all records with the proper document numbering for each document created. A well-made document management system will ensure that documents go through peer review before final release as well.

Maintaining Good Documentation Practices can be challenging. ALCOA+ can be utilized as well to help maintain those practices. EMMA International can help set up a proper document management system and provide training on Good Documentation Practices. EMMA International provides Full Circle Consulting services, give us a call at 248-987-4497 or email us at info@emmainternational.com to get in touch with our team of experts today.

Gabe Kadoo

Gabe Kadoo

Mr. Kadoo is a Quality Engineer at EMMA International. He has experience in statistical analysis, performance improvement, quality assurance, and value stream mapping in the clinical setting. Mr. Kadoo also has experience as a clinical researcher and medical technologist. Mr. Kadoo holds a Bachelor of Science in Biology and a Master of Public Administration with a concentration in Healthcare Administration. He is also a Six Sigma Green Belt.

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