In a production plant, you need to know that your products are produced with the same processes, whether in China or Spain. You must meet ever-changing regulatory requirements and good practices so that you are audit-ready.
What we do
GxP, Quality and Regulatory Consulting
Validation of processes and systems
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:
GxP, quality and regulatory consulting services
in line with 21 CFR Part 11, annex 11 EU GMP, Data Integrity, GAMP5 and GAMP RDI
Validation of systems
processes, analytical methods, tests, facilities, utilities and equipment
GAMP5 and ISPE approaches
in executing automated and equipment validation projects
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
Conformity
with ICH Q8, ICH Q9, and ICH Q10 documents
Accreditations and Standards
