Validation

When we create validation master plans, validation plans, risk assessments and requirement specifications, we take the entire validation process into account and do our best to ensure sound project execution. We always resolve problems as early as possible in the course of the project, so that solutions are as easy and inexpensive as possible. It also prevents delays further down the line.

We are happy to undergo an extra review round to get the perfect result, but we also make sure to match the level to your needs.

We quickly get a grasp of each client’s quality system, and we have a solid understanding of the expectations and inspections of the public authorities, thanks to our many years’ experience in the industry. We thus ensure that the individual document and validation can always be backed by an internal audit or an external inspection.

We are particularly strong within validation of IT and Automation systems in connection with production equipment, but we also validate non-automated production equipment. Overall, our specialists cover everything from HVAC systems to fermentation processes and purification steps in tablet production, aseptic filling, freeze drying and packaging, including sterilisation. We ensure a high level of data integrity all the way.

If you lack qualified QA resources, these can also be provided. More information can be found here.