This is the final installment in PSC Biotech®’s series on Quality Risk Management (QRM) in Commissioning and Qualification (C&Q). This follows on the concepts introduced in the first four installments:

  1. QRM in C&Q Planning
  2. Risk Assessments – One Size Does Not Fit All
  3. Critical Aspects of Pharmaceutical Facilities and Equipment – Identification and Verification
  4. C&Q in the Process Validation Lifecycle

This White Paper applies QRM principles to facility operations in the pharmaceutical industry. Update your Commissioning, Qualification and Validation principles to a science- and risk-based management.

Table of Contents

    • Introduction
    • QRM: Beyond Qualification and Validation
    • Applicability of QRM Concepts to a Site PQS
    • Evaluating the Quality Impact of Legacy Systems/Functions
    • Identification of Critical Aspects
    • Change Control According to Quality Impact
    • Calibration of Instruments
    • Preventative Maintenance
    • Periodic Review and Requalification of Legacy Systems
    • Summary
    • About the Author
    • CQV Outsourcing
Quality Risk Management in Pharmaceutical Facility Operations

Download the Applications for Quality Risk Management in Facility Operations White Paper today!

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PSC Biotech® is one of the largest providers for Commissioning, Qualification, and Validation services for the life science industry, with emphasis on Quality Risk Management. Our team consists of seasoned experts in the validation of facilities, utilities, equipment, computer systems, processes, cleaning, and test methods. We provide end to end solutions with expertise in Project Planning, CQV Master Planning, Requirement Specifications, Risk Assessments, Commissioning, Decommissioning, FATs, SATs, Installation Qualifications, Operational Qualifications, Performance Qualifications, Summary Reports, Traceability Matrixes, Calibration, Temperature/Humidity Mapping Services and more.

We look forward to hearing about your needs in Quality Risk Management and whether we can be of service. Please get started by emailing us at or using our contact form online.

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