A solution that helps you comply with EU GMP and FDA requirements
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 support for the qualification plan, IQ, OQ and PQ, as well as the final qualification report.
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 quality management
For over two decades, we have been developing our platform in close collaboration with companies that need digital solutions for quality management and compliance with legislation and standards.
We understand your challenges and know what it takes to build a robust QMS platform, maintain management systems and take your quality management to the next level.
D4InfoNet is the platform that brings it all together in one place.
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