learning Good Documentation Practices

Offices - learning Good Documentation Practices

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If you've tried Googling the Fda requirements for Good Documentation Practices (Gdp), you'll find that they don't exist because it's an staggering custom and not a Code of Federal Regulations (Cfr) requirement. At best, you can find a few references in the medical device potential Systems manual (Section 9) and Ich Q7A (Section Iv-A).

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Typically, when man uses the term good documentation practices, it's in reference to entering data or development corrections to a controlled record. However, there are other aspects of good documentation practices that contain the formatting of controlled records, signatures and approvals, and document hierarchy. This narrative focuses on how to enter data or make corrections to a controlled record.

The purpose of good documentation practices is to clearly document what actions took place in the amelioration or develop of a drug, biologics, vaccine, medical device, etc. So that anyone, together with an auditor, has documented evidence that you did exactly what you said you did. Keep in mind that a controlled narrative is carefully a legal document, so the data needs to be clearly documented for legal and preservation purposes. In the Biotech commerce we apply good documentation practices with every narrative or document and wish a narrate of the theory while your new hire training. There's a saying that's drilled into you from day one 'If you didn't document it, then it didn't happen'.

Entering Data Into A Controlled Record

Apply the following practices when you're entering data into a controlled record:

Use indelible (water-resistant) blue or black ink so that it doesn't fade over time or smudge if it gets wet. No pencils or felt-tipped markers allowed Enter data directly in the controlled narrative and never on a piece of scrap paper in the interim Never back date! Make sure the entries are precise and legible so that anything can understand your entries Document dates in a standardized format as specified in your proper Operating Procedure Draw a diagonal line through any blank fields or empty spaces at the bottom of a page and contain 'N/A' along with your initials and date. Blank fields can be interpreted as missing data and empty spaces at the bottom of a page (e.g. Lab notebooks) can give man the opening to add data without your knowledge or consent. amount each page in a controlled notebook chronologically. This verifies that no pages are missing Paginate attachments (e.g. Page 1 of 10) For instrument printouts, cleave with clear adhesive tape and contain your initials and date where the printout is attached so that part of your initials/date will be on the attachment and part will be on the notebook When entering repetitive data, do not use ditto marks

Making Corrections To A Controlled Record

Apply the following practices when development corrections to a controlled record:

Draw a singular line through the facts that needs to be corrected, development sure not to scribble out the former data, use white out or write over data (e.g. Turn a zero into the amount nine) because it hides the former data Briefly state what's wrong with the facts (e.g. Wrong date) and document the precise information first and date when the corrections were made Never back date. This is so foremost that it's mentioned twice! Changes or additions to records post approval wish the document go through the approval process again

Although good documentation practices are typically found in Fda regulated industries, it's indubitably beneficial for any commerce to adopt these practices.

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