QAtor helps companies develop and implement GMP compliance strategies, assisting your company with FDA pre and post approval inspections, Quality Assurance / Quality Control documentation review, regulatory interpretation, and submissions.
On request, QAtor can perform audits, and general GMP compliance auditing. Audits are tailored to meet the specific needs of your company and generate implementation of compliance with specific policies to best meet the specific requirements.
QAtor A/S can also assist your group in the development
GMP Quality Systems
We offer consultancy in different areas including:
- Compliance Reviews and Audits
- Master Validation Plan (MVP / VP)
- User Requirement Specifications and Functional Specification (URS / FS)
- Design and Installation Qualification (DQ / IQ)
- Operations and Performance Qualification (OQ / PQ)
- Validation within Equipment, Process, and Computer
- Standard Operating Procedure (SOP)