| If you've tried Googling the FDA requirements for | | | | that anyone can understand your entries |
| Good Documentation Practices (GDP), you'll find that | | | | - Document dates in a standardized format as |
| they don't exist because it's an expected practice | | | | specified in your Standard Operating Procedure |
| and not a Code of Federal Regulations (CFR) | | | | - Draw a diagonal line through any blank fields or |
| requirement. At best, you can find a few references | | | | empty spaces at the bottom of a page and include |
| in the Medical Device Quality Systems manual | | | | 'N/A' along with your initials and date. Blank fields can |
| (Section 9) and ICH Q7A (Section IV-A). | | | | be interpreted as missing data and empty spaces at |
| Typically, when someone uses the term good | | | | the bottom of a page (e.g. lab notebooks) can give |
| documentation practices, it's in reference to entering | | | | someone the opportunity to add data without your |
| data or making corrections to a controlled record. | | | | knowledge or consent. |
| However, there are other aspects of good | | | | - Number each page in a controlled notebook |
| documentation practices that include the formatting | | | | chronologically. This verifies that no pages are missing |
| of controlled records, signatures and approvals, and | | | | - Paginate attachments (e.g. page 1 of 10) |
| document hierarchy. This article focuses on how to | | | | - For instrument printouts, adhere with clear adhesive |
| enter data or make corrections to a controlled | | | | tape and include your initials and date where the |
| record. | | | | printout is attached so that part of your initials/date |
| The purpose of good documentation practices is to | | | | will be on the attachment and part will be on the |
| clearly document what actions took place in the | | | | notebook |
| development or manufacture of a drug, biologics, | | | | - When entering repetitive data, do not use ditto |
| vaccine, medical device, etc. so that anyone, including | | | | marks |
| an auditor, has documented evidence that you did | | | | Making Corrections To A Controlled Record |
| exactly what you said you did. Keep in mind that a | | | | Apply the following practices when making |
| controlled record is considered a legal document, so | | | | corrections to a controlled record: |
| the data needs to be clearly documented for legal | | | | - Draw a single line through the information that |
| and preservation purposes. In the Biotech Industry | | | | needs to be corrected, making sure not to scribble |
| we apply good documentation practices with every | | | | out the original data, use white out or write over |
| record or document and require a review of the | | | | data (e.g. turn a zero into the number nine) because |
| principles during your new hire training. There's a | | | | it hides the original data |
| saying that's drilled into you from day one 'If you | | | | - Briefly state what's wrong with the information (e.g. |
| didn't document it, then it didn't happen'. | | | | wrong date) and document the correct information |
| Entering Data Into A Controlled Record | | | | - Initial and date when the corrections were made |
| Apply the following practices when you're entering | | | | - NEVER back date. This is so important that it's |
| data into a controlled record: | | | | mentioned twice! |
| - Use indelible (water-resistant) blue or black ink so | | | | - Changes or additions to records post approval |
| that it doesn't fade over time or smudge if it gets | | | | require the document go through the approval |
| wet. No pencils or felt-tipped markers allowed | | | | process again |
| - Enter data directly in the controlled record and | | | | Although good documentation practices are typically |
| never on a piece of scrap paper in the interim | | | | found in FDA regulated industries, it's certainly |
| - NEVER back date! | | | | beneficial for any industry to adopt these practices. |
| - Make sure the entries are accurate and legible so | | | | |