Documentation
In regulated industries, documentation is not an add-on. It is an integral part of the solution itself. That is why we work with documentation from the very beginning of a project—not as something that is compiled at the end.
Documentation – audit-ready, clear, and complete
We prepare documentation based on your approval and validation process, ensuring that it supports the work of your QA and validation teams. This applies whether the project is intended for a GMP- or GxP-regulated environment or needs to comply with your internal quality standards.
Documentation is delivered in a clear and structured format that is easy to navigate throughout qualification, commissioning, operation, maintenance, and audits.
Examples of documentation
We work in accordance with applicable requirements for machine safety and CE documentation. When required, we structure documentation to support the principles of GAMP 5, ensuring clear traceability between requirements, risks, design, testing, and approval.
Whether you need technical documentation, operating instructions, or validation support, we ensure that the material is ready for use throughout the project lifecycle—from implementation and daily operation to maintenance and audits.
Documentation structured according to GAMP 5 principles
When a project is intended for a GMP- or GxP-regulated environment, documentation must support both the technical solution and the customer’s validation activities.
That is why we can structure documentation according to GAMP 5 principles whenever relevant to the project. This creates a clear link between requirements, risks, design decisions, testing, and approval, making it easier to assess the solution against its intended use.
We work closely with your QA and validation teams and adapt documentation, test protocols, and approval workflows to fit your internal processes. The result is a stronger foundation for qualification, audits, and day-to-day operation—with traceability and risk management built in from the outset.
