Good Documentation Practices in Action

So, what do Good Documentation Practices actually look like in the real world and at most pharmaceutical companies?

Good Documentation Practices apply to a wide range of activities across an organization; from documenting the cleaning of manufacturing equipment to documenting that you’ve read and understood the S.O.P.s that  apply to your work. All Product (R&D, Production, Post-Market Surveillance / Vigilance), Process, and Quality related documents and records are in scope.

Examples:

Examples of Good Documentation Practices in everyday business operations would include:

• The creation of training records to document attendance of an in-person training or completion of an online eLearning course, like this one.
• Production batch records that are created and maintained to document how a product batch was made, by whom, and following what processes.
• All of the records and reports that are generated from carrying out internal audits
• Documentation of customer complaints regarding any element of a product