Final FDA Computerized Systems Guideline available

GMP News
30 May 2007

Final FDA Computerized Systems Guideline available

The US Food & Drug Administration (FDA) final Guidance for Industry "Computerized Systems Used in Clinical Trials" was published in May 2007. This document provides recommendations regarding the use of computerized systems in clinical investigations. It applies to records in electronic form that are used to create, modify, maintain, archive, retrieve, or transmit clinical data required to be maintained or submitted to the FDA.

This guidance supersedes the guidance with the same name from April 1999 and finalises the draft Guidance for Industry from September 2004. It also supplements the Guidance for Industry on Part 11, Electronic Records; Electronic Signatures – Scope and Application, dated August 2003, when applying these guidances to source data generated at clinical study sites.

FDA's acceptance of data from clinical trials for decision-making purposes depends on the authority's ability to verify the quality and integrity of the data during FDA on-site inspections and audits. Topics that are covered in this Guidance are:

  • Study Protocol
  • Standard Operating Procedures (Appendix A lists 11 processes that should be included in SOPs)
  • Source Documentation and Retention
  • Limited Access
  • Audit Trails
  • Date/Time Stamps
  • Direct Entry of Data
  • Retrieving Data
  • System Documentation
  • System Controls
  • Change Controls

A special emphasis is on Training of Personnel:
"Those who use computerized systems must determine that individuals who develop, maintain, or use computerized systems have the education, training and experience necessary to perform their assigned task."

The complete Guidance for Industry can be found here:

The actual requirements and interpretation of Part 11 for computerized systems in analytical laboratories will be provided in ECA's Education Course "Integrating LIMS with CDS" in Copenhagen, Denmark, from 4-6 July 2007. This new FDA Guideline on 'Computerized Systems Used in Clinical Investigations' will also be presented and discussed in this course.

Also, get more information on how to implement current regulatory developments in ECA's Computer Systems Validation Masterclass in Heidelberg, Germany, from 27-29 June 2007.

A systematic introduction to the principles and methods of the validation of computerised systems is part of the ECA education course Computer Validation in Prague, Czech Republic, from 21-23 November 2007.

Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)

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