Our ‘SOP for Validation’ has been a run away success with over a thousand downloads in the first two weeks. This highly informative SOP is essential reading for all who wish to grasp the overall concept and integration of validation and validation activities. At $16 it is highly cost effective, and is a ready made SOP for your library.
Validation packages are now listed at:
Customers have been requesting more complete validation packages. We have now produced tailored packages for most systems. The benefits of getting all the requisite documents into place quickly and correctly are multitudinous. Whether you are validating a single piece of equipment or a complete facility, getting the correct string of interactive documents in place promptly, makes all the persons involved in the validation task aware of the requirements and the company expectations of them.
Go to the Validation Packages Page
We are continually ask about the role of the VMP.
The regulators expect to see no more than two VMP documents in place for any one facility. That is there will only be two top level validation plans representing how validation has been integrated into all production activities. These are usually, a standard VMP covering the facility, plus a secondary VMP covering a subject or subjects that may involved differing methodology from the plant in general, such as computers or software, or extensive equipment systems such as Distributive Networks (DCS) or Building Management Systems (BMS).
However when it comes to projects, the situation is rather different. Validation Plans are used to define scope and document validation requirements, and where equipment or systems have similar validation requirements, a single VP will suffice. However where the; what, where, why and who, criteria’s are different, more than one VP is required. When more than one VP is required, then a VMP is required to explain, define and authorize the additional VP’s. It is therefore quite normal to see major refits and modifications being covered by a VMP. This does not affect the validity of the main plant VMP.
We give continuous support for all our documentation, and can author any specialized documents you may require.
Please do not hesitate in contacting me if you require further information.