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.

 

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: