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.

What Is Validation and Why Is It Important?

Validation is an essential part of quality assurance, as the compliance of the final product cannot be verified solely by testing individual samples. Quality must be built into the process and production itself, and validation is the means to confirm this.

When validation is performed thoroughly, it ensures patient safety, process reliability, and cost efficiency for the company. Rejecting product batches or carrying out recalls creates significant financial and reputational risks.

Validation is therefore not merely a regulatory requirement but also a prerequisite for profitability and competitiveness. In addition, validation documentation is often part of marketing authorization applications and constitutes a central focus during regulatory inspections.

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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Järjestelmävalidointi, system validation.

System Validation

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

GMP-compliant validations for critical utilities such as water, nitrogen, and compressed air.

Ensure your cleanrooms are compliant – contact us!

Validation Process – 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

Validation Services in Compliance with GMP Requirements

For Cleanrooms, Equipment, Systems, and Utilities

GMP-compliant validations for cleanrooms, equipment, systems and utilities. 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!

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.

Why Choose Feicon as Your Validation Partner?

By choosing Feicon, you gain a partner who offers:

  • Over 20 years of experience in demanding validation projects
  • Broad expertise in cleanrooms, equipment, systems, and utilities
  • Full lifecycle management, from design to commissioning and maintenance
  • A fast and flexible approach, tailored to customer needs
  • Precise documentation that meets regulatory requirements and passes inspections smoothly
  • Long-term customer relationships built on trust and quality

Feicon ensures that validation is carried out correctly, on time, and in support of your business.

FAQ – Validation

The best results are achieved when Feicon’s experts are engaged already during the design and procurement phases. This ensures that the chosen solutions meet all requirements and that commissioning proceeds smoothly without costly modifications.

We offer full lifecycle validation services: from design and risk assessments to commissioning, documentation, and revalidations during the maintenance phase. You may order individual validations or outsource the entire validation process to us.

You gain confidence that your processes and systems comply with regulatory requirements and that documentation is prepared with precision. This reduces risks during inspections, improves cost efficiency, and frees resources for your core operations.

Our experts continuously monitor industry standards and regulatory guidelines. All validations are performed in compliance with GMP requirements, and documentation is prepared to withstand inspections without the need for additional clarifications.

Feicon

Contact Us

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Espoo Office

Kappelikuja 6

FI-02200 Espoo
Kuopio Office
Microkatu 1 K

FI-70210 Kuopio