Business Imperatives

  • A UK-based technology company approached Freyr to identify gaps and assist in addressing the audit findings. 

Objectives

A UK-based technology company was facing challenges in their software for which they approached Freyr to identify proper gaps and assist them in Audit.

Problem Statement

  • Significant gaps were identified in the software system during the customer audit. 
  • The client was on the verge of losing business. 
  • No Regulatory evidence and documentation. 
  • Lack of in-house expertise and awareness about GxP requirements and the consequences of not meeting them.  
  • Lack of GAMP-relevant QMS 

Freyr Solutions and Services

Freyr Solutions and Services
  • Freyr ensured quality and re-structured the entire quality system. 
  • Freyr validated their software with proper documentation of every validation. 
  • Developed QMS portal and deviation & investigation systems that are responsive and result in rapid remediation.  
  • Performed a Re-audit and successfully led the audit on behalf of the client. 
  • Provided End-to-End Services on Compliance and Validation 
  • Ensured a quick turnaround in software validation and addressing findings. 
  • Developed and implemented over 80 Quality Management System (QMS) Standard Operating Procedures (SOPs). 
  • 100% quality compliant.

Validated the software for performance and suitability for its intended use of the QMS portal for responsive and rapid remediation.