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Pharmaceuticals and Biotechnology
Validation Support
Technology validation is intended to defend against accidental product
changes resulting from a change in production assets or materials.
Unfortunately, it also burdens manufacturers with the activities
and expense of validating those changes. We strongly believe that
being a responsible software supplier means helping manufacturers
comply with validation standards. Doing so benefits manufacturers
by enabling the adoption of technologies that will improve their
business operations.
TiPS understands how software creates unique validation issues due
to frequent updates and potential volatility. We have worked closely
with our pharmaceutical and biotech clients to ease the initial
purchase process and to help maintain validated status throughout
version update cycles.
For the initial purchase process, we offer corporate manufacturing
quality documentation and will actively participate in the design
of software validation standards as well as the validation audit
process. Many of our clients have exhaustive validation requirements
and we worked with them side-by-side to pass review and get the
product up and running under the scrutiny of the validation team.
We also support validation trials, where we install a test system
that operates in parallel with the existing control environment.
This allows for evaluation of software performance without impacting
validated operations.
Product updates are another area of focus. Updates add the latest
features and fixes to the product, however they can potentially
interfere with validated status. Tips can assist in providing documentation
or on-site validation resources. A popular alternative is to install
redundant alarm management systems. One system is always validated,
while the other system is used for updates and potentially other
change experimentation. Redundant systems ensures a validated system
is always online, and gives the manufacturer the flexibility and
freedom to update and change another system.
TiPS believes that sustaining a validated alarm management system
and taking advantage of forward-moving technology trends should
not be mutually exclusive.
Products
