Clear quality, clear compliance
Quality compliance and quality assurance management is our forte. Our knowledge of risk management, design, and development combine with our extensive experience in verification and validation of hardware, software, systems, and manufacturing processes to help you meet government regulations and industry standards with the least possible effort on your part. The bottom line: we can help you overcome the obstacles that prevent you from getting your products to market faster.
How we do it
Risk management solutions that are ambiguous or difficult to implement provide no value. At Safis, we apply our risk management knowledge to assess business and compliance risks, advise you on the best course of action, and provide clear, succinct action plans. Our risk management program mitigates risk, helps ensure quality, improves effectiveness, reduces costs, and above all, enhances patient safety.
Quality Program Development
Based on your objectives and business model, we use industry best practices to develop quality programs that meet your objectives in product development research and manufacturing. We are adept at Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).
We provide continuous compliance monitoring to ensure that your projects are effective, current, and compliant. Our areas of expertise include:
- 21 CFR Parts 210 and 211—Pharmaceuticals
- 21 CFR Part 820—Medical Devices
- 21 CFR Part 110—Food
- 21 CFR Part 11—Electronic Records and Electronic Signatures
- 21 CFR Part 58—Non-Clinical Laboratory Studies
- 21 CFR Parts 50, 54, 56, 312, and 314—Clinical Practices
- Q7A—Active Pharmaceutical Ingredients
- European Directives
FDA Citations and Warning Letters
Safis Solutions has extensive experience assessing deviations and corrective actions as articulated in FDA citations and warning letters. Our goal is to provide guidance to our clients, assisting them in meeting the FDA’s requirements for compliance while maintaining patient safety.