Case Studies
Quality Systems established for small pharma.
Forensic Testing company calls on Safis for QS.
Safis goes to school to establish regulatory guidance and compliance oversight.
A startup starts off right with Regulatory Guidance from Safis.
Quality Compliance
Clear quality, clear compliance.
Quality compliance and quality assurance management is our forte. Our knowledge of risk management as well as product design and development combined with our extensive experience in verification and validation of hardware, software, systems, and manufacturing processes 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.
Risk Management
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 and advise you on the best plan of action and provide clear succinct plans of action. Not only does our risk management program mitigate risk, but also helps ensure quality, effectiveness, cost reduction, and above all, patient safety.
Quality Program Development
Based on your objectives and business model, we use industry best practices in developing programs that meet your objectives in product development and manufacturing.
Compliance Monitoring
We provide continuous compliance monitoring to ensure that your projects are effective and up to date and your business remains compliant including:
- 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
- 21 CFR Part 58-Non-Clinical Laboratory Studies
- 21 CFR Parts 50, 54, 56, 312, and 314-Clinical Practices
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, thus, meeting the FDA’s requirements for compliance as well as enabling patient safety.