Validation Services

IT Systems that are developed or implemented within a highly regulated industry  require a compliant Life Cycle Documentation and  a system implementation, that consists of well defined Quality Management methods.

A typical Life Cycle Documentation consists of the following documents:

  • User Requirements
  • Functional Specification
  • Design Specification
  • Design review
  • Installation protocoll / Installation Qualification (IQ)
  • Functional Qualification / Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Risk Assessment
  • Traceability matrix
  • Defect and Issue management log

BENEFITS

  • Secure Systems
  • Reliable Data
  • Compliance to regulations
  • Reduced Risks for inspections

We as LIMSCON can help you with our consultants who have a long experience in Validation Services.

 

METHODOLOGY

  • Valdation is integrated into project plan, phases and milestones
  • Paper less Life Cycle Documentation based on HPALM
  • Paperless Issue and Defect management
  • Risk based testing and validation approach
  • Structured documenton that starts from the processes  and ends on the validation report

 

 

Are you interested?

Please contact us with any questions!