QUALITY MANAGEMENT CONSULTING

The Morris Group specializes in the implementation & optimization of cGMP compliant Quality Management Systems for pharma, biotech and medical device in accordance with FDA and global regulations including; 21 CFR Part 210/211, 820, ISO 9001 and the FDA’s Guidance for Data Integrity.

Our senior consultants have 20+ years of operational experience with end-to-end QMS programs including:

  • Deviations
  • CAPAs
  • Product Complaints
  • Investigations
  • Effectiveness Checks
  • Change Control

 

 

We are experienced with the all major electronic Quality Management and Document Management systems including:

  • TrackWise
  • Documentum
  • Veeva Vault
  • Master Control
  • LiveLink
  • FirstDocs
  • ZenQMS
  • Compliance Wire

Our services include:

  • Audits / Assessments
  • Vendor Selection
  • Remediation
  • Implementation
  • Policies & Procedures
  • Validation