Soltima, Inc

Our Soltima teams experienced in quality management systems, quality system regulations, software system development, business process analysis/modeling, computer systems validation, quality system implementation/support activities, project management, and documentation development; as well as providing solutions for global regulatory requirements and corresponding SDLC activities. Regulatory Content and Development Teams These teams can help to establish policies and procedures related to Computerized System Validation (CSV): Part 11 Compliance and Computerized Systems Policy, Electronic Signature and Record Policy, Security Policy, Computerized System Change Control, Validation of GxP Computerized Systems, Problem Reporting, Risk Assessments, Periodic Review. Project Leadership Teams These teams perform and lead CSV projects related to authoring and executing specifications and validation documentation according to the GAMP5 Validation Life Cycle, including: Computer System Validation Plan, System Requirement Specification (SRS), High Level Risk Assessment (HLRA), Functional Requirement Specification (FRS), Design Specification (Software and Hardware), Commissioning, IQ, OQ, PQ, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems and Audit Trail review. Life Sciences Data Governance Model Development Teams These teams establish guidelines to demonstrate regulatory compliance with data integrity initiatives from different global regulatory agencies. Our Data Governance Model suite enhances and aligns the following, specifically for the life sciences: