You work in a demanding and highly regulated industry. From work instructions to sales literature, you have to manage a multistep process that must comply with regulations and remain accountable at all times. Mystic Management Systems understands that seemingly harmless oversights can delay the launch of new product or result in a damaging warning letter, or worse -- costly fines.
With Mystic Management Systems’ ensur solution, you can manage and control your documentation, easily streamline and automate your workflow, and save time and money. You can rest assured that our experience in working with Life Science companies will help you exemplify GMP, ISO quality guidelines and stay 21 CFR Part 11 compliant.
Mystic Management Systems helps you meet your key objectives:
- Maintain FDA 21 CFR Part 11 compliance
- Manage versioning of SOPs, Work Instructions, Polices, Labels, Specifications, and more
- Adhere to ISO quality guidelines
- Multi-layered Automated Document Security
- Electronic Signatures
- Reporting and Accountability
- Incident Management
- Corrective Action Preventive Action Management
- Product and Packaging Specification Management
- Employee Training Management
- Multi-department collaboration
- Automated Notifications & Distribution