Quality Management Systems and Training Programs

Pharmatech understands the critical relationship between business performance and product quality. We also recognize that when it comes to Quality Management Systems one size does not fit all. Quality Management Systems (QMS) for start-ups in early stages of product development require agility and flexibility while those supporting global commercial operations balance flexibility and agility with standardization throughout the organization’s network. We support our clients with the following services:

Quality Management System (QMS) Services:

  • Develop QMS strategy and roadmap
  • Design and develop partial or complete QMS
  • Develop or improve specific policies and procedures
  • Perform gap assessments
  • Develop remediation plans
  • Integrate QMS due to merger, acquisition, or significant organizational change
  • Improve efficiency of existing QMS processes

Examples of Typical QMS Processes:

  • Supplier Management Programs
  • Data Integrity Controls across the Value Chain
  • Quality Events (nonconformances, deviations, CAPA, complaints, investigations)
  • Change Management (engineering and regulatory)
  • Internal/Supplier/Contract Service Provider Audits
  • Product Realization (design controls, Quality by Design (QbD)
  • Records Management
  • Recalls and Withdrawals
  • Production Records (Device Master File (DMF), Design History File (DHF), batch records, packaging and labeling)
  • Specification and CTM release Processes
  • CPV Support Processes and Systems

Training Program Services:

  • Develop tailored training plans
  • Perform assessments of training programs and methodologies
  • Develop and deliver topic specific training

Examples of Typical Training Processes:

  • Introductory and refresher GxP training
  • Good Documentation Practices
  • Complaint Handling
  • Root Cause Analysis
  • Investigations and Corrective and Preventive Action (CAPA)
  • Quality Risk Management
  • Technical Writing in Regulated industries