Equipment validation services that meet your regulatory requirements

As an industry professional, you're faced with the ongoing challenge of ensuring the quality, safety, and efficiency of your products — while managing guidelines established by the FDA and global regulatory bodies.

Technical expertise

Validation technicians with extensive knowledge of process and manufacturing equipment and the expertise to fulfill your regulatory requirements.

Technical expertise

Validation technicians with extensive knowledge of process and manufacturing equipment and the expertise to fulfill your regulatory requirements.

ISO & GMP/GLP protocols

Custom-written protocols that satisfy ISO, GMP/GLP guidelines — or we follow your established protocols and your acceptance testing requirements.

ISO & GMP/GLP protocols

Custom-written protocols that satisfy ISO, GMP/GLP guidelines — or we follow your established protocols and your acceptance testing requirements.

Full qualification capabilities

Qualification, validation, and re-validation services for new equipment adoptions and periodic re-qualification studies.

Full qualification capabilities

Qualification, validation, and re-validation services for new equipment adoptions and periodic re-qualification studies.

Complete documentation

Delivery of all validation documents, audit-ready. A proven record across pharmaceutical, medical device, and biotech industries.

Complete documentation

Delivery of all validation documents, audit-ready. A proven record across pharmaceutical, medical device, and biotech industries.

Offering

IQ/OQ/PQ and beyond

We conduct validations when a new system or piece of equipment is adopted and needs to be qualified for use, or when a periodic re-qualification study is needed. Our qualifications and validations are created to meet your quality system requirements.

We provide installation, operational, and performance qualification (IQ/OQ/PQ) services for all types of chambers requiring cdocumented mapping and distribution of:

Temperature

Humidity

CO₂

O₂

Getting started

How it works

How it works

Contact us to discuss your validation requirements

Contact us to discuss your validation requirements

01
Share your requirements

Contact us with your equipment details and compliance requirements, we'll take it from there.

01
Share your requirements

Contact us with your equipment details and compliance requirements, we'll take it from there.

02
We develop your protocols

We develop or follow your existing protocols to meet your quality system standards and regulatory requirements.

02
We develop your protocols

We develop or follow your existing protocols to meet your quality system standards and regulatory requirements.

03
Documentation delivered

Validation is completed and all documentation is delivered, audit-ready for your next inspection.

03
Documentation delivered

Validation is completed and all documentation is delivered, audit-ready for your next inspection.

Contact Us

Ready to get your equipment validated?

Contact us today to discuss your validation requirements and how SiteCal can support your quality system.

Contact Us

Ready to get your equipment validated?

Contact us today to discuss your validation requirements and how SiteCal can support your quality system.

Contact Us

Ready to get your equipment validated?

Contact us today to discuss your validation requirements and how SiteCal can support your quality system.