Is your documentation accurate, comprehensible and accessible?

Inadequate validation of electronic record keeping is a frequent citation in FDA 483s and warning letters, and the computer systems involved are critical for ensuring you have control over your processes.

If you have not previously carried out a computer system validation project, you may not be fully aware of the applicable regulatory requirements and how to define the scope of testing.

GxP computer systems that aren’t properly validated can lead to problems both internally — loss of critical data — and externally — regulatory action.

This presentation provides a step-by-step approach to the planning, execution and reporting of computer system validation activities. Validation documents are auditable records which are often reviewed during regulatory inspections. Therefore, it is important to not only perform testing that shows that the system functions as intended, but to adequately document the testing effort and the rationale used to determine the extent of testing.  You will also receive tips on how to adequately manage testing resources to save time and money.

You'll learn the following in the webinar:

  • How to prepare for testing;
  • Types of planning documents such as a master validation plans and qualification/validation plans;
  • How to perform testing in different environments;
  • Tips for writing test scripts and 4 characteristics of well-written test scripts;
  • 5 advantages to executing test scripts electronically;
  • Assembling a team that includes technical and business process experts;
  • How to use GAMP 5 to determine a system’s software category
  • How to define prerequisites for testing;
  • 5 principles of good documentation practices;
  • Do’s and don’ts for ensuring good documentation practices;
  • When annotations are allowed and how to document correctly
  • How to take screen captures to facilitate third-party reviews;
  • Step-by-step approach to documenting and resolving nonconformances;
  • Establishing traceability as proof of system functionality; and
  • Tips for preparing a validation summary report 

Hosted by:

Chrysa Plagiannos-1

Chrysa Plagiannos

Senior Validation and Compliance Analyst, Montrium