SAGE has the experience and understanding to achieve compliance with the codes and regulations for industries such as pharmaceuticals, food and beverages, nutraceuticals, medical devices and health and beauty, and to qualify their respective, applicable systems. Our team of consultants have a strong knowledge and comprehension of current regulations and guidelines from authoritative bodies such as FDA, HPFBI (Health Canada), EMA, USP, ISO and others. We continuously stay informed of regulatory changes to provide expert services on our clients’ projects.
SAGE has the resources to support compliance and validation projects:
- Change Control Initiation & Execution
- Non-Conformance Resolution
- Deviation Closures
- CAPA Execution
- Master and Project Validation Plans
- Environmental Monitoring
- Smoke Studies
- Data Integrity
- Packaging Equipment
- Manufacturing Equipment
- Warehouse Management Systems
- IQ/OQ/PQ/PV/CV/CSV
What We Do
Plan
- Validation Master Plan Development
- Project Validation Plan
- Validation Scheduling
- Site Validation Plan
Design
- Design for GMP and Gap Analysis
- Risk Assessments
- Criticality Assessments
- Failure Modes Effects and Analysis (FMEA)
Implement
- Installation Qualification
- Operational Qualification
- Performance Qualification
- Process Validation
- Quality Management System Implementation
- Lab Equipment and Method Validation
- Computer Systems Validation / Data Integrity
Support
- Procedures and Policies
- Deficiency Reporting and Closures
- Auditing and Audit Responses
- Documentation Preparation and Execution
- Training