In a production plant, you need to know that your products are produced with the same processes, whether in Pennsylvania or California. You must meet ever-changing regulatory requirements and good practices so that you are audit-ready. Dedicated to providing you with long-term value, our team delivers a wide variety of validation services including IQ/OQ/PQ documentation development and support. Our validation experts ensures that your facility and equipment meet regulatory compliance, keeping you audit ready.
What we do
Validation of processes and systems
Equipment validation
GxP, Quality and Regulatory Consulting
The Trescal Advantage
To ensure that life science products are fit for intended use, we document that the manufacturing process can repeatedly produce the intended result. We provide:
Validation of systems
and processes, analytical methods, tests, facilities, utilities and equipment
GxP, quality and regulatory consulting services
in line with 21 CFR Part 11, annex 11 EU GMP, Data Integrity, GAMP5 and GAMP RDI
Process-oriented methodology
consistent with GAMP and ISPE procedures and templates to control costs
Practical solutions
based on ASTM E2500-07 and ISPE guidelines that provide quality and ensure a more cost-controlled, efficient project
Accreditations and Standards
