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With the ever increasing
risks of product liability, validation has become the norm in critical
manufacturing processes across the pharmaceutical industry.
Fully competent in
system validation we can ensure your processes fully comply with the latest
GAMP guidelines and meet or exceed FDA requirements.
Having completed numerous
successful projects, our team of validation engineers have a wealth of
experience in both writing and executing validation protocols.
Validation requires
a high level of detailed documentation and testing across area such as:
- Functional
specification
- Software
specification
- Hardware
specification
- Pre-delivery
Testing
- Factory
Acceptance Testing
- IQ's and
OQ's
which can all be cross
referenced by our traceability matrix methodology.
The rigours of the
validatory process place demands on customers, suppliers and ourselves
alike, which demand a team approach for successful conclusion. Our may
years experience in leading successful teams enables us to ease the pathway
to validation for both our own and 3rd party systems.
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