Good documentation practices should affect the way you fill out forms and make entries in a lab notebook, in the way you enter data and/or correct entries.

What follows is an small list of GDP practices that technicians are expected to follow in STUDENTfacturED. This information is presented in greater detail in the “Standard Operating Procedure: Good Documentation Practices for Handwritten Forms - Standard Operating Procedure”.

There will be several type of documents that you will fill out throughout your time in this program such as lab notebooks, handwritten forms, logs, and electronic records. GDP applies equally to all forms of documentation, however not every GDP principle applies to every type of record. As a technician you will be expected to employ them no matter the type of document that you are filling out.

Remember that these are guidelines that one follows in recording raw data entries in a legible, traceable and reproducible manner. Ultimately it is more than any company policy or principle. It is a mindset, that you can take anywhere. The key to thinking in GDP terms is to consider these questions each time you record any data:

1. Is it true?
2. Is it accurate?
3. Is it timely?
4. Is it legible?

I do want you to be familiar with and be able to apply everything listed in the SOP, but the requirements are there to help you think in these terms and apply them to your documentation.

What follows is a basic list of GDP, this is not an exhaustive list by far, but it can give you a taste of GDP with a few important ones to keep in mind. In this course we will be filling out forms by hand so those are the GDP principles that are more important at this point. In future courses electronic records will be introduced.

- Accurate records ensure that activities are documented, including what occurred, and when it occurred. The FDA considers that if an activity is not documented, it didn't happen.
  - This is super important never make up data or estimate when something happened or how much of something was used. Always be accurate. If you don’t know document that, and why you don’t know.
- Use permanent, reproducible blue ink. Do not use pencil.
  - We will always have blue pens for use in the lab. All paperwork needs to be filled out using them or a pen of a similar color. Pencil can be erased so data integrity is not certain
- Mistakes in paperwork are to be corrected immediately upon detection.
  - Always fix mistakes!
- Write legible and clearly, so that the information may not be interpreted incorrectly. Do not rush through the recording activity.
  - Please take your time! If someone else cannot read your work it is essentially like you did not document at all. Records have to be able to be independently verified, like in an audit or when someone else is replicating or reviewing your work
- Do not document the work of another employee.
  - Never do this! Part of the integrity of the our documents rests on the fact that we can be certain of the identity of the person filling out the records. If you are falsifying a record by putting someone else's name on the form then we cannot be certain of any other information you or they have provided.
- The date format is to be written as Day Abbreviated Month Year (04Aug2014).
  - Just get used to this one. We want no ambiguity in date. Depending on the format you are using the date August first 1980 could be written as MMDDYY = 08/01/80, DDMMYY = 01/08/1980. Proper GDP requires the format of 01AUG1980 so there is no ambiguity
- Make a single line through an error being corrected. Do not “scribble” out or make more than one line through the error. The original data must be readable and/or visible.
  - The point of a correction is not to obliterate a mistake, it's to correct the mistake in such a way that we can verify the mistake. In order to do that we need to be able to see the original error
- Write the corrected information as close as possible to the lined-out error.
  - This is so you can see immediately what the correction is, and someone does not have to go looking for the corrected information
- Provide a reason for the error change. The reason should be numbered and described at the bottom of the page or in the comments section of the document.
  - Error explanations, such as “Oops!” or “Wrong.” are inadequate. The reason for the error change must be fully explained initialed and dated.
    - We need to see someone's reasoning as to why a correction was made so we can validate the the correction

As I said above these procedures are just guidelines and it is not an exhaustive list. These procedures are listed in the document “Good documentation Practices for Handwritten Forms - Standard Operating Procedure”. They help ensure that the data is accurate and can be trusted. It also allows us to demonstrate compliance to regulations to a regulatory body. This is all part of the control of our documents, remember this all goes back to safety and efficacy. Now that you understand how to access the Document management system you will be able to access the SOP any time you need it.

Learning Objectives:

- 2.4 - Complete appropriate documentation using good documentation practices contemporaneously to making a product.