Quality Management Systems

QMS Assessment, Development, and Implementation

A robust Quality Management System (QMS) provides a systematic approach to issue resolution and process improvement. RegDev's team of experts collaborate with clients to understand their current QMS needs, identify gaps, provide solutions, and assess effectiveness of existing systems.

RegDev's QMS reviews provide expertise on International Council for Harmonisation (ICH) GCP, European, UK, and US FDA regulatory requirements and trends.

Our QMS services include support in designing and developing robust QMS, SOP and Work Instruction development, Quality Planning, Quality Risk Management, and development of a Root Cause Analysis and Corrective Action and Preventive Action Plan.

Our services also include support in designing and implementing a QMS, providing input on:

Gap Assessments
Quality Planning
Quality Risk Management
Quality System design and implementation based on US and International standards
Quality Manual Development
SOP (and accompanying documents) Development, Review, and Training:
- Document Control Programs
- Change Management
- Nonconforming Product Issues
- CAPA Programs (Support, Metrics, Analytics, and Trending)
- Production and Process Controls
- Contract Service Provider Oversight
- Quality Agreements
- Root Cause Analysis
Development and support of procedural documents
Development and support of Software Development Life Cycle (SDLC) procedures
Development and support of Validation documentation
IT Systems Validation / 21 CFR Part 11 Assessments
Deviations/Investigations
Vendor Qualification and Management
ICH E6(R2) Addendum Assessment Supports

Quality Management Systems

QMS Assessment, Development, and Implementation

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