Basic Data Intergrity

Basic Data Integrity and Good Documentation Practice for laboratory personnel


What will you learn?

Working in or supporting a QC laboratory, you come into contact with a lot of data and documented evidence that products comply with the safety, quality, identity, purity, and potency which they claim to have. Data Integrity is a hot topic these days and many serious audit observations are about this area of GxP. Although Data Integrity is not new, it has become an area of increased focus. In fact, if employees do not adhere to the principles, it can result in disciplinary action and even dismissal. It is therefore, important to understand the principles of Data Integrity and Good Documentation Practice to prevent misunderstanding and unnecessary audit observations and investigations (although most Data Integrity mistakes are unintentional, it can be taken very seriously).

The exercises were designed to provide maximum coverage of the learning material, and expose you to many different “real-life” scenarios specific to the QC laboratory environment. In true PharmaSkills fashion, we will only use practical examples and exercises.

At the end of this training module, you should be able to:

  • Define the principles of Good Documentation Practice (GDocP).
  • Understand the requirements of document life cycle in compliance with Good Documentation Practice.
  • Understand the basic principles of Data Integrity (ALCOA+) and how it is applied in practice.

Who will benefit from this course?

This training module has been designed to fulfil the following potential needs of a QC laboratory:

  • It will be helpful as an annual refresher course for all existing laboratory personnel.
  • It is also ideal as part of a training curriculum for newly appointed staff at a QC laboratory.
  • It will be valuable for QA personnel overseeing QC laboratory audits and self-inspections.
  • If you are not currently working in a QC laboratory, or still busy with your studies, this module will explain the concept of Data Integrity and Good Documentation Practice, and will provide you.