Benefit from the expertise of a skilled and seasoned team

Meet the challenges of CSA and CSV delivery with Orise’s Computerized System Lifecycle Management Program

 

Ensuring that critical GxP infrastructure, computer systems and software are implemented and delivered in accordance with strict industry regulations can be challenging for life sciences organisations. Validation projects supporting this activity are often complex, costly and time-consuming.

 

By partnering with Orise for the delivery of your Computer System Validation (CSV) and Computer Software Assurance (CSA) projects, your company will benefit from the expertise of a skilled and seasoned team offering the very best practices in testing and validation, as well as reductions in overheads, resource management and project costs. Orise has a proven track record in successfully helping companies comply with strict industry standards such as the FDA’s 21 Part 11 and EMA’s Annex 11.

 

Utilize our best-practice Computerized System Lifecycle Management Program for:

  • Project management
  • Skilled, scalable and flexible resource allocation
  • Project timeline and budget delivery
  • Comprehensive system user requirement specification delivery
  • Validation plan delivery
  • Design documentation delivery
  • 21 CFR Part 11 requirement delivery for electronic records and signatures
  • Commissioning
  • Qualification and verification
  • Release

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