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An Update of Good Laboratory Practice Guidelines for Computer Validation

Otherwise known as the DIA’s Red Apple Document, one of the industry's oldest guidance publications is finally overhauled

R. D. McDowall

One of the oldest guidance documents for computerized system validation is entitled Computerized Systems Used in Non-Clinical Safety Assessment,¹ otherwise known as the Red Apple Document. This was originally published in 1988 so it’s a bit long in the tooth and rather outdated. However, following a new conference two years ago, a new version was published in May 2008.² As with the original publication, it is for the Good Laboratory Practice (GLP) fraternity and is published by the Drug Information Association (DIA).

The book is divided into eight chapters:
• System Life Cycle
• Validation Plan
• Quality in a Regulated Environment
• Security
• Long Term Retention of Electronic Records
• Business Continuity and Disaster Recovery
• Infrastructure
• Instruments and Computerised Equipment

The first three chapters discuss aspects of computer validation, the next three chapters look at the protection of the records generated by a system and the last two chapters cover important concepts for the application of IT and instruments in a GLP environment. To my mind, the chapter titles and their arrangement look as if they have been pulled at random from a lucky dip and dropped on the page. The lifecycle is covered in outline, but a validation plan is discussed in great detail when, in fact, the most important document in the life cycle — the user requirement specification — does not get the coverage it deserves.

One item on validation plans caught my eye in Chapter 2: the table entitled Matrix 4 shows the tasks and responsibilities for the installation and qualification of a firewall in the IT infrastructure. There are up to 24 separate qualification tasks, including writing SOPs, but this is for a firewall. If everyone did this, companies would be out of business. Risk management? Don’t worry, just feel the thickness of the qualification documentation!! Is it any wonder that, in some instances, computerized system validation has a bad name for being slow and not adding value to an organization?

References
1. Computerised Systems used in Non-Clinical Safety Assessment, Drug Information Association, Maple Glen, PA,1988
2. Computerised Systems used in Non-Clinical Safety Assessment — Current Concepts in Validation and Compliance, Drug Information Association, Horsham, PA, 2008

R.D. McDowall is Principal, McDowall Consulting. He may be contacted at editor@ScientificComputing.com.