The FDA Compliant, Corporate Quality Manual (CQM) is a lengthy fully detailed manual containing all the policies and procedures that the regulatory authorities require approved organizations, to have in place.
The Corporate Validation Manual is the start of all compliant documentation. The policies container in it, dictate what documents must be raised and details the scopes and responsibilities in raising, approving and executing them. Here our CQM goes a great deal further, in containing interactive downloadable templates for, Validation Master Plan - VMP -, , Design Qualification - DQ -,, Installation Qualification - IQ -,, Operational Qualification - OQ - ,, Performance Qualification - PQ -,, User Requirements Specification - URS -, , and many more documents, all of which are compliant with Good Manufacturing Procedures GMP, GAMP 4, Food and Drug Authority - FDA - and Medicines and Healthcare Regulatory Agency - MHRA - (MHRA), rules and regulations. Authoring and publishing a Corporate Validation Manual is a long drawn out and expensive process. A single author will usually take six to nine months to produce one. A similar amount of time is required from peers, in reviewing and editing.
Our FDA Compliant, manual preface is constructed in the format of an Standard Operation Procedure - SOP - as an SOP. This SOP takes you through the simple stage of populating the Corporate Validation Manual. This standard manual is now your new company bespoke manual.

Computer System Validation - CSV - encompasses the largest range of validation tasks that the validation specialist has to cope with. Ranging from relatively simple data loggers up to facility wide Distributive Control Systems - DCS -, the variation in complexity, is at times, challenging. Very often you are dealing with new or extended programs, leading to glitches in the field, and vendor fixes. What a horrible word that is – Vendor Fixes. Then of course you get vendor fixes for vendor fixes, then you arrive at the state that the vendor looses control, of what fix is where. Result one - 8000 i/o system, 9 months late, result two - 18,000 i/o system 16 months late. The next requirement was for a green field site in Asia, a 25,000 expandable to 35,000 i/o point system. We decided it was essential to audit the vendor (yes eventually). The audit (the same VA document that is available from Validation Online) revealed a whole host of digressions from the software design life cycle advocated by the FDA and other quality organizations. It became obvious why their software was so disconnected. It was also very apparent that if you wanted trouble free software, then planning and open management of software design, were the most important phases of the whole software production cycle. The development and execution of a quality DQ, prior to commencement of coding was the paramount feature found missing in our audit. There were many things missing, but most of these would have been caught, directly or indirectly, if the DQ had been properly authored and executed.

So FDA Compliant along with Validation Online has authored a very detailed Computer Validation Master Plan, a document that although subservient to the site VMP, takes it’s place along side, the site VMP. It details all aspects of the company’s validation of computers. To complement this document, Computer Installation Qualification (CSV-IQ) and Computer Operational Qualification (CSV-OQ) are also available from the site. To cater for the smaller systems a combined computer IQ and OQ has been produced, the CSV-IO/OQ. Thses are fully referenced, interactive formated documents, which at the IQ stage verifies whether 21 CFR Part 11 is applicable to the equipment/system, and if it it is, at the OQ stage has all the test scripts built in to verify compliance with the requirement.

All regulatory required FDA Compliant documentation must be carefully prepared, with statements worded to preclude ambiguous and incorrect interpretations of the purpose of the statement. In addition there are quite separate requirements stipulated by the regulatory authorities. Documents presented to regulators during inspections that fail to satisfy these requirements, indicate to the regulator a lack of care and commitment on the part of the company. The exact opposite to what is required.
The FDA and regulatory authorities in general, are charged with increasing the level of compliance throughout the industry. This call for increased regulatory compliance, is driven by evidence that the industry is failing to match the standards set by other regulated industries.
FDA Compliant, and Validation Online, have designed unique interactive documents for all validation activities such as VMP, URS, IQ, OQ, PQ, and many others. These documents have all been designed to be cGMP, FDA compliant, along with incorporating the structures the regulators look for. These documents are realistically priced to ensure it is much more cost effective for companies to download documents as they require them, than individually author them.

This definitive 1000 + page manual arrives with you in DVD format, complete with a search facility that enables you at any time to have the benefit of over thirty years of validation experience and wisdom, right beside you. Enabling you to access references, instantly down load test scripts, and above all, have access to the best FDA Compliant document templates available anywhere.
If you have background knowledge in pharmaceuticals and are reasonably competent, the Definitive Validation Manual will do the rest for you. If you are in the Pharmaceutical / Biotechnological / API / Medical Device, industries or whether your in any of the engineering streams that are involved with these industries, the Definitive Validation Manual will enable you to:-

The cost of the FDA Compliant, Definitive Validation Manual, will be recouped in the first few weeks, it will then go on to show a massive return on your original investment.