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 specific policies to best meet the specific requirements.
QAtor can also assist your group in the development of GMP Quality Systems .
Based on more than 2 decades of industry experience within Quality Assurance, QAtor provides consultancy in:
- 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)
QAtor provides your organization with a range of solution choices to cost-effectively plan, implement, and operate your Life Sciences compliance management applications. Our predictive consulting services rapidly assess your needs and design a solution on a fixed-time, fixed-cost basis.
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