Giving our clients a head start

It is vital for our clients to be able to start manufacturing quickly, without hiccups that hold up progress. The complexity and compliance demands that come with increasing automation, emerging Industry 4.0 advances, tightening regulations, and the like make this more difficult.

Exyte’s services also include commissioning, qualification, and validation to the given standards, for example, to ensure cGMP and FDA compliance. Beyond that, we also provide inventory documentation and document management, process optimization, upgrades, and retrofitting services. Our knowledge and skills hone our clients’ competitive edge.

Benefit from the full range and combination of services

  • Commissioning & start-up
  • Qualification & validation
  • As built documentation
  • Optimization, upgrades & retrofits

 

 Commissioning, Qualification & Validation for your industry

"Product quality and patient safety have increasingly shifted into the digital domain. We support our clients in protecting their automated GMP-compliant production process."

 

Holger Mettler
Head of Computer System 
Validation & Cyber Security, BLS


 

Project reference

Pioneer in hospital pharmacies – Kantonsapotheke Zürich (KAZ)

The KAZ is a FOYA-winning hospital pharmacy that produces a wide range of medications, many in small quantities and with patient-specific formulations. Highly flexible and extendible, the KAZ is designed to easily and quickly accommodate new functions such as personalized medicine, while meeting or even exceeding industrial cGMP standards.

CQV services provided by Exyte

• Validate, monitor, test, and commission processing, water treatment, and environmental monitoring equipment and systems to GMP standards

• Engineer, assemble, commission, and qualify cleanroom HVAC systems and mechanical installations

• Qualify and validate all GMP-relevant installations, including the IT system The KAZ facility was the first to raise

the quality bar for a hospital pharmacy to the cGMP standard.

External view of Kantonsapotheke

The Facility of the Year Awards recognize state-of-the-art projects that use innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery.

Read more about ISPE’s 2019 Facility of the Year Award

External view of Kantonsapotheke

Discover our scope of services