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...
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...
LIMS Implementation Reduces Testing Cycle Times and Dramatically Cuts Costs
After years of paper-based laboratory testing processes, our pharmaceutical client was looking to make strides in a...
Global Document Management Solution Reduces Infrastructure Cost, Harmonizes Practices
The Brevitas team supported the replacement of three legacy systems with a global document management system that...
Data Integrity Compliance Project Completed Ahead of Schedule and Under Budget
An internal audit of a top generic pharmaceutical manufacturer identified deficiencies in their legacy computerized systems related...
Computer System Validation Compliance Audit of Cloud Systems
The Brevitas team conducted a Computer System Validation audit on two recently updated and validated cloud systems....