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Validating software as a service

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The complexities of domestic and international regulatory requirements cannot be underestimated.

What’s more, governments and other parties involved are constantly amending them.

Pharmaceutical manufacturers and other organisations operating under GMP-regulations have been hesitant to adopt cloud-based IT solutions.

This is usually because they want to retain their data within their own four walls and because of the difficulty in maintaining the validated state of cloud based software that can be updated without warning by the vendor.

We have written (and executed) commercially available validation packages.

We can provide any level of service required, from executing test scripts generated from your existing specifications to writing the entire validation package.

It was always known that if you wanted software, you had to put it on a box, and someone had to maintain that box.

Arbour Group is a trusted advisor to over 250 pharmaceutical, medical device and biotechnology companies worldwide.

Let us demonstrate how we can integrate seamlessly into your organization, prove ourselves a valuable business partner and deliver effective services that reduce compliance costs.

Computer Software Validation is a formalized, documented process for testing computer software and systems, required by 21 CFR 11.10(a) and Annex 11, Section 4.

The FDA and other regulatory bodies require validation to demonstrate that computer systems are in compliance with all regulations for electronic data management systems.