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
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
Please do not hesitate in contacting me if you require further