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Consulting Services

Quality Management System (QMS) Consulting

Building, optimizing, and remediating pharmaceutical quality management systems to ensure robust compliance, operational efficiency, and regulatory confidence across your organization.

QMS Development CAPA Systems SOP Writing Change Control Data Integrity

Quality Systems That Drive Compliance and Business Performance

A robust Quality Management System is the backbone of pharmaceutical regulatory compliance. Whether you are building a QMS from the ground up, remediating an existing system following regulatory observations, or optimizing quality processes for efficiency, GxP Global Quality Network delivers practical, compliant quality system solutions.

Quality systems must work for your organization, balancing regulatory rigor with operational practicality. The approach is collaborative, hands-on, and focused on sustainable compliance.

QMS Services

  • Quality management system design, development, and implementation
  • QMS gap assessments against 21 CFR Part 211, ICH Q10, and ISO standards
  • Standard Operating Procedure (SOP) writing, review, and harmonization
  • CAPA system development: root cause analysis, effectiveness checks, trending
  • Deviation and non-conformance management system design
  • Change control program development and documentation
  • Document management system design and optimization
  • Product complaints and adverse event reporting system development

QMS Remediation

  • Post-inspection QMS remediation following FDA 483 observations or Warning Letters
  • Quality system maturity assessments and improvement roadmaps
  • Risk-based quality management program development (ICH Q9)
  • Annual Product Review (APR) / Product Quality Review (PQR) programs
  • Supplier quality management program design

Data Integrity

Network auditors specialize in data integrity compliance programs aligned with ALCOA+ principles, FDA guidance, and MHRA expectations, including 21 CFR Part 11 assessments for computerized systems, audit trail reviews, and data integrity gap remediation programs.

Quality standard: All GxP Global Quality Network engagements are led by senior-credentialed auditors with 20+ years of active GxP audit experience, regulatory currency across FDA, EMA, MHRA, and Health Canada standards, and direct accountability for every deliverable.