Comprehensive Controlled Project Delivery for Regulated Clients
Matrix Technologies has developed hundreds of projects within regulated environments. Our unique combination of automation expertise and validation methodology can help you save time and money. Matrix provides regulatory services to the world’s leading pharmaceutical and food manufacturers.
We take a controlled approach to design and implementation to ensure that documented systems and code are “controlled” and meet applicable federal, state, and local regulations and industry standards.
For the typical automation project in a regulated industry, we provide the following design documents and practices:
- Code Review
- SOP-based Development
- Change Management/ Control
- Revision Control
- Leveraged FAT and “Integrator Site” Qualification
Related Compliance Delivery Offerings
Along with the standard automation deliverables, Matrix can assist with the following functions as well, truly delivering an integrated project lifecycle:
- Lifecycle Documentation Generation/Execution – User Requirements, Validation/Verification Plans, Remediation Plans, Criticality Assessments (system/component), Risk Assessments, Test Plans, Installation and Operational Qualification/Verification and Reports
- cGMP / GAMP 5 – Customer Training, Site/System Audits and Implementation
- 21 CRF Part 11 – Assessments, Audits, Training, and Compliance
- Regulatory Project Planning – Integrated Commissioning and Qualification, FAT/Vendor and Startup Test Leveraging, Vendor Management, Risk-Based Testing Approach, Standard and E2500 Project Delivery
- Computer System Validation – Identifying and Resolving Discrepancies or Deficiencies Regulatory SOP Development for Automated Systems – Backup and Restoration, Disaster Recover, Business Continuity, Security Management, User Management, System Operation and more.
Discover why Matrix is your best choice for implementing your next major regulatory project.