Across all industries, documentation is a key aspect of maintaining good quality and traceability over products. Therefore, having good documentation practices (GDP) is an essential tool and something that requires repetitive training to ensure proficiency. Especially in the life science industries, having good documentation improves overall product quality and allows for clearer traceability and validation within processes. GDP practices can be done using the acronym, ALCOA, which stands for Attributable, Legible, Contemporaneous, Original, and Accurate.
- Attributable (A)- meaning that the data can be associated with the person who wrote it. This often comes in the form of signatures added after any data recorded indicating who wrote it.
- Legible (L)- meaning that the data can be clearly read and easily understood by all. This can be optimized by avoiding handwritten notes, when possible, clearly explaining what happened, and making sure that everything flows together in a logical way.
- Contemporaneous (C)- meaning that the data was taken at the same time as when the event was occurring and that documents must be kept up to date. Often times this results in dates being applied when changes or notes are made and using the most recent copy of a document.
- Original (O)- meaning that the data itself is the original copy and has not been edited since its transcription. Any alterations to the data must clearly show what was changed, by whom it was changed and when it was changed. If there are errors within the data, comments can be made provided they are by the person who transcribed the original data.
- Accurate (A)- meaning that the data is true, valid, and correct. Data should be reviewed and checked only by people who are trained on the task being performed. If errors should arise from the original data, corrections can be made but documentation must be done to show the errors, the reason for the correction, and why the correction is valid.
If you need support in using documentation to improve product quality, the experts at EMMA International can help! Call us at 248-987-4497 or email us at info@emmainternational.com to learn more.
