What is Good Documentation Practice in 90 Seconds or Less
Автор: Paul Yeatman BSc.
Загружено: 2020-08-23
Просмотров: 416
Описание:
Good documentation practices are where you have written procedures, follow them and record all of your results. There are a number of rules to good documentation practice:
1. If it was not documented, it did not happen
2. If it was documented, but poorly, it did not happen either
3. Do not forget rules 1 and 2.
4. My Rule 4 – if if was dodgy and not documented, it happened!
Following these rules ensures your data is accurate, you data has integrity, you are regulatory complaint and auditors cannot cite you for dodgy paperwork.
That was Good Documentation Practice in 90 seconds thereabouts.
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I am a microbiologist who analyses and improves the controlled processes of pharmaceutical manufacturing companies allowing them to release batches sooner while also allowing them to operate in an audit ready state so they can reduce or eliminate their audit observations.
Skilled in FDA, TGA & EU GxP regs & guidelines. 15+ yrs pharmaceutical microbiology expertise.
I have solid technical writing skills, a wealth of industry knowledge and a visual communication diploma.
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