For reliable manufacturing and laboratory processes
Normec supports organisations with the validation and calibration of laboratory and manufacturing equipment. Using a structured approach, our specialists verify whether equipment complies with internal procedures, customer requirements and applicable GMP and ISO standards.
This helps organisations demonstrate that their processes remain reliable, safe and compliant.
Equipment validation throughout the entire lifecycle
We support organisations throughout the entire lifecycle of their equipment, from selection and commissioning to periodic inspections and eventual decommissioning.
Our services include:
- Support with equipment selection and procurement
- Equipment commissioning and periodic validation
- Calibration and performance testing
- Guidance during equipment decommissioning
- Documentation in accordance with applicable GDP guidelines
- Development of validation plans for each type of equipment
Validation plans and risk management
Effective equipment validation goes beyond testing alone. For each piece of equipment or system, we develop an appropriate validation plan to document performance, reliability and compliance.
Our validation approach includes:
- User Requirements Specifications (URS) for equipment
- Risk assessments and evaluation of critical parameters
- Preparation of test protocols and test plans
- Documentation of results and approval for use
- Development of user procedures
- Support with change control and deviation management
With our support, you can:
- Strengthen compliance with GMP and ISO guidelines
- Demonstrate the reliability of your equipment
- Improve the management of deviations and process risks
- Be well prepared for audits and inspections
- Support safe and consistent manufacturing processes
Maintenance, periodic inspections and collaboration
Reliable equipment requires structured maintenance and clear coordination between all stakeholders. That is why we support organisations in planning periodic maintenance, calibration and validation activities.
We work closely with all relevant disciplines, including:
- Laboratory staff
- Operators
- Technical services
- Validation specialists
We also support the development of Corrective and Preventive Actions (CAPAs) to address deviations effectively and prevent recurrence.
Future-ready equipment
With our structured approach and extensive knowledge of international regulations, Normec helps organisations ensure that equipment remains reliable, safe and fit for the future in critical manufacturing and laboratory environments.
Would you like to know more about equipment validation and calibration?
Frequently Asked Questions
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Equipment validation is the process of verifying and documenting that equipment meets predefined requirements and is suitable for its intended use.
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Validation helps organisations demonstrate reliable equipment performance, product quality and compliance with applicable regulations.
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Calibration verifies that measuring equipment provides accurate and reliable measurement results within specified tolerances.
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A User Requirements Specification (URS) defines the functional and technical requirements that equipment must meet.
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Equipment decommissioning is the controlled removal of equipment from service in accordance with established procedures and regulatory requirements.
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We work in accordance with GMP, GDP and applicable ISO guidelines.
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We support organisations operating in the pharmaceutical, biotechnology, medical device and high-tech industries.