| Health & Life Sciences is a demanding and highly regulated industry.
Organizations face the challenge of compliance with numerous regulatory requirements such as Good Manufacturing Practices (GMPs),
Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs),
FDA 21 CFR Part 11, Sarbanes-Oxley (SOX), and ISO standards. Quality System Integrators provides
the software solutions to manage the information
required for quality and compliance. Our TMS Quality Management
Compliance System streamlines and automates your processes to save time and money, improve quality and reduce risk.
Key objectives TMS helps you meet are:
- Electronic Signatures (FDA 21 CFR Part 11)
- Manage documentation versioning of SOPs, Work Instructions,
Specifications, Regulatory Filing, and more
- Adhere to ISO quality guidelines
- Multi-layered Automated Document Security
- Manage Employee Competence / Awareness / Training
- Manage Online Quizzing and Track Results
- Reporting and Accountability
- Design and Customize Electronic Forms
- Internal and External Audit Management
- Corrective / Preventive Action Management (CAPA)
- Multi-Department / Global Collaboration
- Automated Notifications & Distribution
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