TESTING AND QUALIFICATION SERVICES

With 25 years of experience with some of the top clients in the Life science and Biotech sector such as Amgen, Boehringer Ingelheim, Genetech, Novartis, J&J, Shire Pharmaceuticals and Sanofi Pasteur, we pride ourselves in being subject matter experts in testing and qualification activities.
 
  • We continue to build and deliver core competencies in Business and System analysis, Quality Compliance, Commissioning and Qualification (C&Q) projects and project management.
  • Our team uses risk based approaches for managing multiple projects for a wide range of systems and equipment. We have successfully implemented System, Process, Cleaning and Equipment Validation projects for our clients. 
  • Our team uses GMP guidelines and lean methodologies to engineer validation deliverables such as  Design Specifications, User Requirements, Functional Requirements, Test cases (IQ,OQ and PQ), Validation Reports, and traceability matrices.
  • We are actively involved in C&Q projects relating to PLC, Delta – V Distributed Control Systems (DCS) and Manufacturing execution systems (MES).

RISK ASSESSMENTS AND MITIGATION SERVICES

Our expertise in implementing lean methodologies forms a major component of our value proposition. In Capital projects, our ability to conduct detailed risk and criticality assessments for any new or existing programs, people and systems helps client capture value and cut down redundancies and costs.

  • Global Compliance Partners is a Certified Continuous Improvement (CI) Practitioner – and has Implemented Lean Six Sigma methodologies, 5S and Kaizen at different client sites.
  • We conduct and lead risk assessment meetings to analyze the severity, probability of occurrence, and likelihood of detection for system related hazards using Preliminary Hazard Analysis methodology.
  • We have championed lean methodologies by conducting impact assessments, value/non value assessments, root cause analysis, fish bone analysis, Pareto analysis, and Failure mode & Effect Analysis (FMEA).
  • Global Compliance Partners pro-actively manages changes in project scope, identifies potential crises, and foresees any deviation and mitigation plans.
     

STRATEGIC ADVISORY SERVICES

Our leadership has leveraged its business acumen and its reputation of solving complex issues to deliver Strategic Advisory Services. We advice clients on project management and analytical solutions to improve patient experience and deliver better health and economic outcomes.

  1. Our team works in a dynamic cross functional setting to help clients create project road maps.
  2. We partner with clients to help them conduct vendor assessments.
  3. We provide critical analytical support in the decision to consolidate manufacturing and work to migrate manufacturing programs, processes, people and equipment.
  4. We provide dedicated assistance to several integration teams, including, Human Resources, Information Technology, Finance, R&D, Facilities, Automation, Quality Assurance, Engineering and Manufacturing.
  5. We develop client specific talent retention strategies that balance business continuity and help maintain its quality standards.
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