Computer Systems Validation
Our Validation Vision
Those who work in regulated industries such as pharmaceuticals and medical
devices have extra responsibilities that are not found elsewhere as their
products can both save or shorten lives. For a manufacturing company therefore,
demonstrating that it is on the right side of the line is the prime objective of
the business model. It's a major task and involves compliance to guidelines set
by both the industry and regulatory bodies such as the FDA. The guidance covers
GMP, GAMP, Change Management, 21 CFR Part 11, Software Verification, Process
Validation, Equipment Validation,and much more. EQS has been
providing validation services for many years, offering independent advice and
resources to companies big and small who must work within the FDA regulations.
Computer Validation
As the pharmaceutical and medical device industries increasingly rely on
automation so the quality of computer software is assuming greater significance
in their operations. FDA regulations impose on drug and device makers an
obligation to ensure that the software they use, from a yield-calculating
spreadsheet to the PLC code and control algorithms used in the manufacture of
the product, is of suitable quality - whether written in-house or purchased with
the equipment. Software and computer validation is a technical skill that few
companies have: they can rely on EQS to advise on what needs
to be done to achieve the greatest benefit. EQS can help your organisation
to:
Realise the benefits of working to GAMP 4
Guide the 21 CFR Part 11 compliance effort
Write Clear Specifications
Assess suppliers source code, organise testing and much more...
Suppliers to the sector are learning what they must do to meet their customers
software and computer validation expectations: work to an agreed plan, keep
appropriate records, banish ambiguity, be aware of the clients documentation
plan and make your paperwork fit into it. Often these suppliers attend meetings
where their paperwork is criticised, deadlines are missed, code is redesigned
and payments delayed. Avoid these costly problems by involving EQS
computer validation team in your project.