Medical Device Software

 
 

Verification & Validation Services

Product software requirements Spec


Computer system validation OF MANUFACtURING EQUIPMENT

GAMP5 COMPLIANT

  • Improve the quality of your manufacturing equipment while complying with the latest standards.

VERIFICATION & VALIDATION FOR LEVEL 3, 4, & 5 SYSTEMS

  • Process Software
  • Custom software requiring a full software development life cycle.

REMEDIATION PROJECTS

  • Meet new standards through verification and validation and/or software quality oversight.
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Complete Software Development Life Cycle   

Planning of the software development process including methodologies and tools

  • Software Development Plan
  • Standard Operating Procedures

Configuration Management

Quality

Scalability

Verification and Validation


Workflow Process Automation


TEST TOOL AUTOMATION


FDA SOFTWARE COMPLIANCE AUDITS


Spreadsheet & Database Validation