Commissioning & Qualification

A modern and integrated approach.

Why?

Every tool used in the manufacturing process has a high impact on product quality.

Validate procedures, materials, equipments and systems
Establish a consistent product delivery
Prove with documented evidence the reliability of the processes
Avoid rejection, reworks and down time
Ensure compliance with regulatory authorities’ standards

What is included?

All our solutions

Qualification Protocols Writing and Execution
Installation, Operational and Performance Qualification
Validation Master Plan
Commissioning Plan
Cleaning Validation
Process Validation
Media Fill Protocols
Calibration services
Witnessing of Supplier Testing Activities (FAT/SAT support)
Inventory of Process Equipment and Utilities
Quality Risk Management
User Requirement Specifications
Technology Transfer
Process Analytical Technology (PAT) Support
Clean Room Qualification
Temperature Mapping Services
Transport Validation

We know what we are doing.

Don’t believe us? Check out the material put together by our team of experts.

Annex I update

Sterile facilities are a complex context: from process equipment qualification to clean utilities, our guide can help you understand the newest regulation related to the Annex I update of the Eudralex.

Webinar

Browse our Knowledge Gallery and view our free webinar about how to design a strategic site master plan when building your facility or view another of our free webinars available in your language.

Ask us anything.

Our top experts and engineers are ready to help.

Get in touch for a free evaluation call with our team today.

Commissioning & Qualification

Why?

What is included?

All our solutions

We know what we are doing.

Annex I update

Webinar

Related articles on our blog

Ask us anything.

Discover PQE

Useful Links

Change Language