Biotech / Pharmaceutical – Regulatory Services

Regulatory Services

Controlled Project Delivery for Regulated Clients

Matrix Technologies understands that delivery of projects within a regulated environment typically requires a controlled approach to design and implementation. This is done to ensure that documented systems and code are “controlled” and meet applicable federal, state, and local regulations and industry standards. Our unique combination of automation expertise and validation methodology can help you save time and money. Matrix Technologies is your best choice for implementing your next major biotech regulatory services project.

Automation Delivery

For the typical automation project in a regulated industry, the following design documents and practices are included:

  • Standards
  • Code Review
  • SOP based development
  • Change Management/ Control
  • Revision Control
  • Leveraged FAT and “integrator site” Qualification
  • Training

Related Compliance Delivery Offerings

Coupled 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 – Discrepancies or deficiencies are not only identified but also resolved by our team.
  • Regulatory SOP Development for Automated Systems – Backup and Restoration, Disaster Recover, Business Continuity, Security Management, User Management, System Operation, and more.