Validation

We ensure the validation and compliance of cleanrooms, equipment, systems, and processes throughout their entire lifecycle in accordance with GMP standards and regulatory requirements.

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Comprehensive Validation Expertise

Solutions for Various Applications and Needs

Cleanroom Validation

We provide GMP-compliant measurements and reporting in accordance with ISO 14644, delivered promptly and reliably.
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Equipment Validation

We perform equipment validations for, among others, production equipment and processes, washing machines, and autoclaves.
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System Validation

We have extensive experience of over twenty years in system validations.
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Process Validation

We support our clients in the planning and execution of process validation.
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Validation Services in Compliance with GMP Requirements

For Cleanrooms, Equipment, Systems, and Processes

GMP-compliant validations for cleanrooms, equipment, systems and processes. We perform individual validations or, alternatively, manage the maintenance of validity during the entire life cycle. If necessary, we consult and support our clients in the pre-planning phase of cleanrooms as well as equipment and system procurement.

Validations are always performed by our qualified experts based on the requirements and instructions of both the client and the authorities.

Puhdastila validointi ja mittaukset Feiconilta.

Ensure your cleanrooms are compliant – contact us!

Validity Lifecycle Management

From Commissioning to Maintenance

Commissioning Phase

  • Creation of user requirement
  • Risk assessments
  • Creation of validation plan and testing protocol
  • Performing the validation and reporting
  • Creation of SOP instructions and implementation training

Operation and Maintenance Phase

  • Change management
  • Training and support
  • Variance control and CAPA process
  • Maintenance schedule
  • Regular assessments and revalidations

Cleanroom Validation

Validation Process Phases

Validation includes four stages. Depending on the client’s needs, we can perform all the validation stages.

Design Qualification (DQ)

Design inspection. The plans are in accordance with the requirements of the client and the authorities.

Installation Qualification (IQ)

Installation inspection. The installations are carried out according to the approved plans and requirements.

Operational Qualification (OQ)

Testing the functionalities.

Performance Qualification (PQ)

Testing the performance and the overall process.

Feicon

Contact Us

Submit a contact request using the form below or get in touch directly:

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Espoo Office

Kappelikuja 6

FI-02200 Espoo
Kuopio Office
Microkatu 1 K

FI-70210 Kuopio