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Validation Solutions for Your Unique Needs

Computers, processes, and equipment are all governed by complex standards of practice. Not knowing whether your systems are in compliance leaves you feeling out of the loop. Fortunately, our San Francisco, California company is here to provide you with validation services of every variety. 

Computer Validation

VTI computer system validation engineers will help ensure that your computerized systems are developed and qualified, following a structured life cycle approach consistent with the Good Automated Manufacturing Practice (GAMP5) guidance.

A Proven Process That Benefits You

We have developed a process and a suite of services designed to ensure that you are in compliance with the applicable sections of the cGMP/GLP/GCP and 21 CFR Part 11. This process will assure the quality of computerized systems throughout the development or execution of requirements, specifications, design, coding, testing, installation, and acceptance. This process includes the following steps customized to your unique needs:

Supplier/Vendor Audits | Client Validation Life Cycle Audit | 21 CFR Part 11 Audits/ Remediation Plans | Policies and Procedures Development | Software Validation | Validation Plans | Disaster Recovery Plans | Operation and Security SOPs | Change Management and Control | System User Requirements and Design Documents | Protocols, Test Plans, and Test Scripts | 21 CFR Part 11 Training | Equipment/Utilities

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Process Validation

Process validation provides documented evidence that manufacturing processes consistently produce a product that meets predetermined specifications. The process validation approach assesses critical unit operations at each step of the process, as governed by Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).

VTI has over a decade of experience in successfully managing and executing process validation projects in Europe, Asia, and the Middle East, as well as the United States and Canada. We deliver world-class service and industry-wide best practice solutions to your company, while ensuring that your validation processes comply with regulatory expectations; whether they are subject to regulation by the FDA, the EU, or any other regulatory body.

Thermal Validation

Our qualified validation consultants provide world-class thermal validation services to the majority of Fortune 500™ pharmaceutical and biotech companies, and we are ready to deliver that same world-class service to your company. VTI uses industry standard Kaye® and Veriteq® (temperature and humidity) instruments for thermal validation projects. All thermal validation test equipment is fully certified and calibrated to National Institute of Standards and Technology (NIST) traceable standards.

Our Capabilities Include:

Temperature and Humidity Room and Warehouse Qualifications | Temperature Mapping | Shipping Validation | Steam-in-Place (SIP) | Sterilization Validation

Cleaning Validation

Cleaning validation ensures that equipment cleaning procedures accurately remove residues to predetermined levels of acceptability. We comply with inspection consistency and uniformity for the cleaning validation program with guidance from the FDA's "Guide to Inspection of Bulk Pharmaceutical Chemicals" and the "Biotechnology Inspection Guide."

VTI can help you with all aspects of your cleaning validation program. Our qualified validation consultants have the necessary expertise to develop and improve your cleaning validation methods and procedures. Before beginning our work, we will provide you with clear expectations and deliverables for each step and, of course, customize each process to meet your unique needs.