Expertise in Equipment validation
Equipment validation
Because every lab and production environment within life sciences and high-tech industries must comply with strict regulations, it is extremely important to properly validate (lab) equipment. For that, you can rely on Normec.
Meeting Every Standard
Ensuring the quality of the final product is crucial, especially in life sciences and high-tech industries. That’s why you rely on dependable equipment and why thorough validation is a must. Using a series of procedures and tests, your dedicated Normec expert checks whether each device meets relevant regulatory and customer requirements. It’s how we help you deliver consistent quality, time and again.
The initial validation of a device confirms that it meets internal guidelines, industry regulations, and relevant ISO standards. After that, we carry out regular checks to ensure everything continues to function as it should. Our clear procedures help guarantee that each device is used correctly and stays in top condition, allowing your organisation to produce safely.
JulieSenior Project Engineer
With Normec, you can rely on a team of dedicated engineers. Each an experienced expert in the life sciences industry — and each with their own area of specialisation.
Equipment validation
Professional support throughout the life cycle of your device, including:
Selection and purchase of appliances
Release for use and periodic in-use validations
Correctly withdrawing from service through decommissioning
Accurate documentation according to applicable GDP rules
Development of a validation plan for each specific type to ensure sustainable use, including:
User Requirement Specifications (URS) to be met by the device
Risk-analysis
How the device will be tested
Overview of tests
Final report for release
Preparing a user procedure
Planning necessary periodic maintenance with all parties involved, taking into account:
Lab technicians
Operators
Technicians
Validation engineers
Preparation of corrective and preventive actions to handle and prevent deviations correctly
Documentation of changes using change controls
