CSV and SOP – get ready for inspection

13 October 2010 | By Michael Fenger, Managing Consultant at NNIT

Standard Operation Procedures (SOP) are an integral part of any life science company – the very license to operate depends on defined, documented and verified processes and procedures. However, within the life science industry many are unaware of the fact that SOPs are also an integral part of Computer System Validation. You can’t have a compliant computer system without having a SOP describing how to validate and maintain it. So in order to get fully inspection ready you need SOPs for the computer systems.

Usually the regulatory authorities don’t perform inspections at life science companies directly related to the computer systems. The primary focus is on the processes and production facilities. But actually quite a lot of the non-conformities found during inspections are related to computer systems as they increasingly become an integrated part of the business processes. Therefore, computer system validation more often comes up during the course of an inspection.

In order to respond to this challenge life science companies must acknowledge that computer systems are an integral part of the regulated production equipment. As a consequence, the IT department should be integrated with the divisions supported by IT systems and QA should have adequate knowledge on computer related regulatory requirements and processes.

Computer System SOP
Some of the central SOPs to have in place in order to be in compliance in relation to computer systems are:

Computer System Validation SOP outlining and detailing the central activities in the validation life cycle and the software development life cycle
Change Control SOP describing the process for controlling both software and hardware in the production environment
Configuration Management SOP describing how to control all configuration items part of an IT system
Security Management SOP describing requirements to backup, restore, physical access to buildings and data centres, networks, and passwords

Apart from these SOPs you of course need a wide variety of supporting SOPs such as computer system inventory list, quality manual, document management, problem management etc.

SOP life cycle
NNIT has a ‘life cycle’ approach to working with SOP. A SOP exists to answer or support a business need, and the life cycle of a SOP therefore has following phases:

Gathering data relevant for the SOP
Analysing existing and future business processes covered by the SOP
Facilitating workshops/interviews regarding business requirements and needs
Identification and guidance regarding regulative requirements related to the SOP
Writing the SOP
Management of the SOP commenting process from stakeholders (e.g. affected business units, QA, management)
Management of the SOP approval process, incl. required changes request handling
Continual review and improvement process regarding SOP and SOP updates to ensure alignment with changing business needs
Termination of the SOP including assessments on the need to document and support both previous and future business processes

Let us help you with your SOPs
NNIT has extensive experience in all of the above listed aspects of SOP writing. We develop SOPs on a continual basis for a number of life sciences companies supporting both IT and business processes, and we help companies develop and implement a complete computer system SOP framework.