c-Compliance
Consultancy led by Anders Clausen, M.Sc. (pharm.), providing quality assurance and regulatory compliance support to pharmaceutical-related organizations. Core activities include implementation of quality systems, GMP/GLP/GCP auditing, validation and qualification of analytical and production equipment, computerized system compliance (21 CFR Part 11), and batch-release / Qualified Person advisory services.
Industries
Nr. of Employees
small (1-50)
c-Compliance
Services
Advisory services for development and implementation of pharmaceutical quality management systems and QA governance.
Execution of internal, supplier and third-party audits across production, laboratories, packaging, and clinical sites.
Validation of analytical methods, qualification of laboratory and production equipment, and support during facility rebuilds and equipment installation.
Project management and QA oversight for implementation of computerized/document management systems in compliance with 21 CFR Part 11.
Advisory services relating to batch release processes, Qualified Person responsibilities, handling of non-conformities and change control.
Advisory services for development and implementation of pharmaceutical quality management systems and QA governance.
Execution of internal, supplier and third-party audits across production, laboratories, packaging, and clinical sites.
Validation of analytical methods, qualification of laboratory and production equipment, and support during facility rebuilds and equipment installation.
Project management and QA oversight for implementation of computerized/document management systems in compliance with 21 CFR Part 11.
Advisory services relating to batch release processes, Qualified Person responsibilities, handling of non-conformities and change control.
Expertise Areas
- Quality assurance for pharmaceuticals
- GMP/GLP auditing
- GCP compliance and clinical site auditing
- Computerized system compliance (21 CFR Part 11)
Key Technologies
- GMP/GLP/GCP auditing methodologies
- Analytical method validation
- Equipment qualification (IQ/OQ/PQ)
- Computerized system validation and 21 CFR Part 11 compliance