Benchmarking Quality in the Healthcare Sector: Integration Across the Global Enterprise

STUDY OVERVIEW

Pharmaceutical, biotechnology and medical device companies spend millions to ensure their products meet quality standards at every stage of the product life cycle, from R&D to post-market support. One of the main challenges facing quality groups in global companies is integrating quality across the different functional areas that make up an organization's global enterprise.

Best Practices, LLC conducted this study to capture current approaches of leading companies for integrating quality across their global business operations. In particular, this study probes structure and global quality management, use of digital technology, and managing quality for GLP, GCP and GMP. There is also a chapter on quality management in pharmacovigilance.

Quality leaders can use this study to improve their integration of quality across their global enterprise.

KEY TOPICS

• Quality Structure and Global Management
• Digital Technology & Quality Improvement Catalysts
• Quality Management in GLP / GCP
• Quality Management in GMP and Logistics
• Quality Management in Pharmacovigilance (PV)

SAMPLE KEY METRICS

• Rate maturity of your global quality management system
• How is your global function organized
• Rate the effectiveness of these quality approaches for global operations
• Where has digital technologies provided greatest benefit
• Evaluate the effectiveness of digital technology and software tools
• Indicate scope and breadth of your clinical trials and development programs that quality supports
• Rate the effectiveness of these tools and approaches in managing GCP and GLP
• What are the most critical measures to ensure quality management of manufacturing
• What role does pharmacovigilance quality assurance play in each of these audit activities

SAMPLE KEY FINDINGS

• Digital technology shows promise adding value to manufacturing, software and customer support and across operations, patient experience, big data analytics, metrics, innovation and profit improvement.
• Technology is adding value to diverse quality functions including CAPAs, Complaint mgmt., Non-conforming events, vendor management, training & Audit.

METHODOLOGY

The research employed a data gathering approach that reaps quantitative & qualitative data from
a diverse group of 22 companies.

Industries Profiled:
Medical Device; Pharmaceutical; Diagnostic; Manufacturing; Consulting; Biotech; Biopharmaceutical; Health Care; Clinical Research; Laboratories


Companies Profiled:
Boston Scientific; idera pharmaceuticals; Astellas; seracare; GlaxoSmithKline ; GN Hearing; 3M Company; Neopharm; Amgen; NewLink Genetics; Abbvie; Takeda Pharmaceuticals; Daiichi Sankyo; DePuy Synthes; Baxter Healthcare; Novartis; Tesaro; Biogen; Sanofi; Abbott; Medtronic; Beckman Coulter

If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.