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It is more apparent month by month that the emphasis has change, in the definition of Validation - from the original standard requiring documented evidence of consistent performance - to the concept of satisfying requirements.  This of course has brought the attention more on the requirements documentation than before.  With this slightly different approach the Design Qualification has been raised from a document that was always “nice to have”, to a document that is essential in giving assurance that your functional specification will deliver your User Requirements Specification.

With software this is essential, with hardware it still works and works extremely well, all that is required is to maintain traceability across the string of documents.  Remember without clearly defined requirements, you cannot construct a precise Design Qualification protocol.  This link, URS to DQ, has become one of the most important steps in all validation projects.

Unless you are working on a new product and wish to develop unique equipment – stay away from design.  Allow your vendors to come up with their solution for your requirement.  No matter whether it is a new design or an off the shelf design, the full DQ must be carried out.  End users who get involved in design are often left in the embarrassing situation, where the vendor refers to them; as the designers.  As such they have to accept responsibility for the design performance.  There are several examples around the country where this has become a horrendous multi-million pound disaster (try Porton Down for one).       

We receive many enquiries regarding the scope and content of the Validation Master Plans (VMP).  The VMP must give a visiting regulator a quick and precise overall idea of the company structure, facility and activities.  Where the company has more than one product – a section in the VMP must relate to this giving a brief description of the each product and the production processes involved in producing it.  There must be one VMP for the whole facility, with perhaps one for a major system (DCS – BMS – Computers), every thing else should cascade down from these top documents, with VP’s defining scope and responsibilities.  Keep the VMP to a top level overall document.  Do not get into detail.

New documents since our last news issue.

Computer Validation,  CSV-IQ,  CSV-OQ, and a combined CSV-IQ/OQ, this document is ideal for the smaller computer controlled/monitored/managed piece of production equipment or laboratory equipment.  

Free on the site is the Vendor Audit Check List, a very handy document, not the same as the Vendor Audit in our shop, which also has an analysis tool which allows you to prioritize and personalize the audit scoring, to enable accurate and justified comparisons to be presented to your client or manager.