Regulatory and Standards Compliance

Inspections, permits and plans in accordance to local, state and federal regulations.

• Quality Systems Documentation Development and Implementation
- Quality Manual
- Procedures
- Work Instructions
- Forms

• Internal Audits as per company requirements.

• External Audits to suppliers and contractors.

• Inspection and Development of Quality Systems in compliance to the code of Federal Regulations and ISO Standards.
- 21 CFR Part 820
- 21 CFR Part 11
- 21 CFR Part 210
- 21 CFR Part 211

• Inspections, permits and plans in accordance to local and federal regulations.

• Validation Activities
- Validation Standards
- Protocol and Report Generation (IQ, OQ, PQ, PPQ, Commissioning, etc.)