Quality Assurance

Vitalea has an evolved and well tested 21CFR part 58 GLP compliant Quality System

• Over 70 QA and Procedural SOPs under 2-year review cycle
• Document control and archiving systems
• Computerized systems assessed for 21CFR Part 11 compliance
• Change Control System
• Validated AMS and UPLC systems
• Internal Audit Schedule

Industry Standard Report Templates

Extensive Internal QC procedures prior to report initiation

Proven Track Record

Many successful Client Audits completed by all sizes of pharmaceutical and biotechnology companies

We design our systems for 21CFR part 58 compliance and following the FDA and ICH guidance for Bioanalytical Method Validation. We have written the most extensive review paper on the "Validation of the AMS method for Pharmaceutical Science". This paper is available upon request.

Vitalea is at the forefront of defining the QC/QA process for AMS analysis and has the only AMS instrument validated to the GLPs for regulated clinical work.