Computerized Systems Validation

We have on staff professionals in systems design, validation and Part 11 with Compliance Managers to assist you with equipment, packaging lines, PLC's, SCADA's, BAS, LIMS, MRP, and SAP systems. Some areas in which we can provide support are listed below:

Validation Master Plan
Vendor Audits
User Requirements Specification (URS)
Functional Requirements Spec. (FRS)
Technical Design Specification (TDS)
Requirements Tracability Matrix (RTM)
Source Code Review
System Startup & Commissioning
Installation Qualification
Operational Qualification
System Summary Report
Periodic Review