Your company is part of a demanding and highly regulated industry. From work instructions to standard operating procedures to sales literature, you have to manage a multistep process that must comply with regulations and remain accountable at all times. DocXellent understands that seemingly harmless oversights can delay the launch of new product and result in lost revenue.
With DocXellent’s document control software, Life Sciences companies manage and control documentation, easily streamline and automate their workflow, and save time and manpower managing document versioning standards and approvals. Rest assured that our experience in working with Life Science companies will help you exemplify GMP, ISO requirements for document control and stay 21 CFR Part 11 compliant. As a total quality management solution, ENSUR provides all the tools needed to meet ISO quality standards, regulations, and industry requirements.
DocXellent helps 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 standards
- Multi-layered Automated Document Security
- Electronic Signatures
- Reporting and Accountability
- Incident Management
- Corrective Action Preventative Action Management
- Product and Packaging Specification Management
- Employee Training Management
- Multi-department collaboration
- Automated Notifications & Distribution