A solution that helps you comply with EU GMP and FDA regulations
Do you operate under regulatory requirements where systems must be validated, for example in accordance with EU GMP or FDA regulations?
We support your validation efforts and the documentation required to demonstrate that the platform is used in a controlled manner and in accordance with your organisation’s requirements.
Document all changes with a structured Change Control process
We offer a standard validation package with documentation to support the validation process. The package includes, among other things, QP, IQ, OQ and TV, enabling the validation work to be carried out on a documented basis.
When changes are made to the platform’s configuration, our Change Control process ensures that all changes are registered, assessed and documented. This gives you full traceability of what has been changed, when the change was made and who approved it.
More than 25 years of experience in regulated environments
For more than 25 years, we have worked with companies operating under extensive requirements for documentation, traceability and validation.
We understand the requirements and expectations of auditors and regulatory authorities, and we know how important it is to be able to document both how the system is used and the changes made along the way.
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