Swiss Working Group on Information Technology Publishes GLP Validation GuidanceA very practical and useful document with some interesting approaches
R. D. McDowall
The Working Group on Information Technology (AGIT in German) is a collaboration of Swiss inspectors and experts from the pharmaceutical industry working to Good Laboratory Practice (GLP). This group has published four very practical and useful guidance documents on IT within GLP since 2000.
1-4 The first one on Guideline for the Validation of Computerized Systems
1 was updated in December 2007 and is an interesting contrast with the Parenteral Drug Association (PDA) guidance.
5
Similar to the Drug Information Association (DIA) Red Apple document, there is a high emphasis on the validation plan and report for a system, as the writers equate these documents to a GLP study protocol and report. This is fine, but both publications omit a detailed discussion of the most critical document in the whole validation package: the user requirements specification (URS). If we spent more time and effort on the URS, our validation efforts and the resulting systems would be so much better and would actually meet business objectives and regulatory requirements.
One area where there are some interesting approaches is the discussion of which systems should be validated, and this is linked to a listing of system categories in Appendix 1. In parallel to USP <1058> on Analytical Instrument Qualification, there are three categories of “system” and, in an attempt to simplify validation, we get some silly issues that arise.
P For example, for an operating system (OS), no action is recommended and the only documentation is an inventory listing and system description. I believe this is rather short-sighted. You need to know if the OS has been installed correctly, as well as the internet protocol address and other configuration information, in order to get the OS to work in a networked environment. In addition, you also will need to know which service pack has been installed, as this may impact the application that runs on the server or workstation. The same comments apply to databases which are treated the same as an OS. However, both the OS and the database are part of a bigger system and are never used on their own. Installation of the OS and database should be part of these validations.
P In Categories B and C, there are mentions of “restricted customization” and “extended customization” of software, respectively. The problem is that customization is not defined in the document. To my mind, this refers to writing custom code rather than to configuring the software, and it may give readers a different view than the writers anticipated. Perhaps it is better to borrow the definitions from GAMP, and category B should be standard software (either as ROM or installed from CD) and category C should be configured software without custom elements?
Risk management at both the system and functional level is introduced into the validation process. The latter is important, since the authors note that that you may only use 20 percent of the functions of an application. So, why validate the ones you don’t use? However, only a single life-cycle model is outlined, which does not give laboratories the full flexibility that the GAMP guide gives now. The guidance ignores the configuration of the software and its documentation, which is most important in many of the applications used in a GLP environment. Also, the vendor audit is placed outside of the usual validation process in a little cubby-hole at the back of the document. A good feature in Section 9 is an outline of 11 SOPs required to support a computerized system in a GLP environment, although this could be applied to any quality environment.
References
1. Guidelines for the Validation of Computerised Systems, v01, AGIT, 2000
2. Guidelines for the Management of Electronic Standard Operating Procedures (SOPs) in a GLP Environment, v01, 2001
3. Guidelines for the Archiving of Electronic Raw Data in a GLP Environment, v01, 2003
4. Guidelines for the Acquisition and Processing of Electronic Raw Data in a GLP Environment, v01, 2005
5. Guidelines for the Validation of Computerised Systems, v02, AGIT, 2007
Note: All current versions of these documents are available for download at: www.bag.admin.ch/themen/chemikalien/00253/00539/03300/index.html?lang=en R.D. McDowall is Principal, McDowall Consulting. He may be contacted at editor@ScientificComputing.com.