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Services Provided:

As a specialist in LIMS Validation, my consulting services provide a stepwise approach to validation that parallels the software development life cycle process of your LIMS. For each phase of development, the following critical validation documents are created:

  • Vendor Selection
  • Validation Plan
  • User Requirements Specification
  • Functional Requirements Specification
  • Design Specification
  • Configuration Specification
  • Custom Code Specification
  • GAP Analysis Report
  • Vendor Audit Report
  • RISK Assessment Report
  • Traceability Matrix
  • Standard Operating Procedures
  • IQ/OQ/PQ Validation Protocols including Test Scripts
  • IQ/OQ/PQ Summary Reports
  • Data Migration Protocol including Test Scripts
  • Data Migration Summary Report
  • Validation Summary Report
  • Custom Training Course(s)

These documents may vary, be called by a different name or be merged at your company. The above list is meant to serve only as an example. All deliverables are named and formatted according to the standards of your company, and their development follows the specific Standard Operating Procedures and templates of your organization.

My services can be used for any or all of the above processes and deliverables. I have done everything from the well orchestrated 'soup to nuts' validation to the emergency 'we must go live in a month and need you just for PQ'. My clients drive the scope of my involvement and the validation deliverables that I develop. Projects can range from a few days to several months, depending on the need. 

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