Commissioning, Qualification & Validation

Brevitas Consulting - Pharmaceutical

Comprehensive CQV Strategy Guarantees Successful Startup

Commissioning, Qualification and Validation (CQV) activities play a crucial role in delivering operationally effective and compliant facilities, utilities, equipment and process. We support our clients throughout the full CQV lifecycle, from early stage of user requirements gathering to start-up and operations handover. A comprehensive approach is taken together with the client’s interdisciplinary team during CQV process to facilitate a timely and cost-effective solution. During the course of our engagement, we continually educate your team, to facilitate knowledge transfer and ensure long-term sustainability.

Comprehensive CQV Strategy Guarantees Successful Startup

Commissioning, Qualification and Validation (CQV) activities play a crucial role in delivering operationally effective and compliant facilities, utilities, equipment and process. We support our clients throughout the full CQV lifecycle, from early stage of user requirements gathering to start-up and operations handover. A comprehensive approach is taken together with the client’s interdisciplinary team during CQV process to facilitate a timely and cost-effective solution. During the course of our engagement, we continually educate your team, to facilitate knowledge transfer and ensure long-term sustainability.

Brevitas Consulting - Pharmaceutical
Brevitas Consulting - Pharmaceutical

CQV Services

Experienced in the vertical take-off after construction completion, we deliver value to your projects through the following CQV services:

  • Establish basis and optimize CQV processes at regulated facilities
  • Attain quality compliance to regulatory requirements and alignment with business goals
  • Achieve technical assurance for the impacted systems and processes
  • Ensure operational readiness for turnover
  • Deliver project with high quality on-time & on-budget
Brevitas Consulting - Pharmaceutical

CQV Services

Experienced in the vertical take-off after construction completion, we deliver value to your projects through the following CQV services:

  • Establish basis and optimize CQV processes at regulated facilities
  • Attain quality compliance to regulatory requirements and alignment with business goals
  • Achieve technical assurance for the impacted systems and processes
  • Ensure operational readiness for turnover
  • Deliver project with high quality on-time & on-budget

Project Management

  • Validation Project Scoping
  • Risk Assessment
  • Execution Strategy Development
  • Resource Strategy Development
  • Project Status Monitoring & Reporting
  • Change Request Management
  • Performance Management
  • Commissioning, Qualification & Validation Planning

Commissioning & Qualification

  • Validation Master Plan Development
  • Requirements Traceability
  • Design Qualification (DQ) Development/Execution
  • Commissioning (FAT, SAT) Development
  • Installation, Operational, Performance Qualification (IQ/OQ/PQ) Execution

Validation

  • Process Validation (PV)
  • Computer System Validation (CSV) Compliant to Data integrity and 21 CFR Part 11
  • Automation System Validation
  • Sterilization Validation
  • Cleaning Validation (CV)
  • Media Fill Validation
  • Laboratory Equipment Validation
  • Analytical Method Validation
  • Environmental Monitoring

Case Studies

Brevitas Consulting - Pharmaceutical Case Studies

Walk-In Refigerator

In order to upgrade their WIRs to GMP standards, our Global Pharmaceutical client retained the services of the Brevitas consultants to provide project management leadership to address gaps, resource constraints, engineering design, and compliance issues.

Facility Air Compressor C&Q

Brevitas’ dedicated professionals oversaw the commissioning of three strategic projects within the engineering portfolio for a leading pharmaceutical company. With our expertise in project management and technical assurance , we successfully addressed compliance gaps, improved system redundancy, increased raw material testing capacity and reduced raw material testing cycle times.

LIMS

After years of paper-based laboratory testing processes, our pharmaceutical client was looking to make strides in a competitive industry by implementing a Laboratory Information Management System. Brevitas played a key role in driving this innovative project to success.

Data Integrity

An internal audit of a top generic pharmaceutical manufacturer identified deficiencies in their legacy computerized systems related to SDLC requirements (GAMP standards, FDA 21 CFR Part 11 & Data Integrity). Brevitas consultants were enlisted to deliver an effective solution to bring the existing systems into regulatory compliance.

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