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- Commissioning, Qualification & Validation
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Insights into Improvements: Building a Targeted Roadmap for ISO 9001 Aligned Optimization
Our client manages a global repository of biological data and conducts an annual certification process to ensure...
Closing IT Gaps to Achieve Audit Readiness
Brevitas executed a risk-based GMP IT audit readiness assessment across a regulated vaccine and biologics environment. The...
GMP Audit Readiness for CGT Operations
Brevitas was engaged to conduct an audit-readiness assessment using a risk-based approach to identify compliance gaps and...
Accelerating GMP Readiness Through Risk-Based CQV and Strategic Execution
Brevitas deployed a risk-based CQV strategy leveraging GxP test prioritization, clear system boundaries, leveraging commissioning data, proactive...
Regulatory Readiness: Brevitas’ Targeted Strategies for GMP Qualification of 50+ Benchtop CGT Systems
The Brevitas team developed and executed protocols for the qualification of over 50 benchtop CGT systems for...
Driving Efficiency: Streamlining the Qualification of 15 BSCs with QRM, Project & Vendor Management
Brevitas streamlined the qualification of 15 Biosafety Cabinets (BSCs) by applying Quality Risk Management (QRM) principles and...
Airflow Visualization Study to Address Audit Observations
Our client, a CDMO in the biopharmaceutical industry retained the services of the Brevitas team to help...
Validation Framework and Data Integrity Program for CGT Non-Profit Organization
A Non-Profit Organization creating cell and gene therapies was looking to improve their CSV, CQV, and data...
Serialization and Aggregation Readiness for US Products
A Global Pharmaceutical client required implementation of aggregation functionality for their packaging lines as part of the...
GMP Drug Manufacturing Policy Development
Our Drug Manufacturing Client is currently in Phase 3 Clinical Trails. They retained the services of the...
