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Our experts at AltaQ help companies to effectively meet software compliance and validation requirements. This includes establishing compliance processes for full SDLC (Software Development Life Cycle) and software validation including compliance with 21 CFR and Part 11.

Our expertise covers the following systems:

  • Software Development Support (Software Development Life Cycle)

  • Software Development Plan (SDP)

  • Software Development Document (SDD)

  • Software Verification and Validation Plan (SVVP)

  • Software Requirement Traceability Matrix (SRTM)

  • Software Validation Test Scripts

  • Software Configuration Management and Change Control Procedures

  • Software System Compliance and Validation

  • Electronic Document Management Systems (EDMS)

  • CAPA Management Systems

  • Enterprise Resource Planning (ERP)

  • Manufacturing Execution Systems (MES)

  • Automated Manufacturing Equipment

  • Laboratory Information Management System (LMS)

AltaQ helps clients from the evaluation/assessment phase (gap analysis) through final validation, execution, and summary reports. AltaQ has the expertise to provide the following deliverables based on clients' needs:

  • 21 CFR PART 11 Assessment and Remediation (Gap Analysis)

  • Preparation of Validation Master Plan

  • Validation Project Management

  • Development of User, System Design, and Functional Requirements

  • IQI/OQ/PG/Development

  • Execution of Validation Protocols

  • Development and/or Evaluation of Standard Operating Procedures (SOPs)

  • Customized Employee Training

  • Software Vendor Audits and Qualification

  • Final Validation Summary Report. 


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