Auditing Warehouse Operations

Auditing Warehouse Operations

Frequently, a significant portion of most pharma manufacturing facilities is the warehouse operations area. Under this “pharma” umbrella we would include chemical manufacturers, API manufacturers, finished pharmaceutical manufacturers and contract manufacturing...
Software as a Service

Software as a Service

Software as a Service (SaaS) products are being utilized by Life Science companies to address solutions for some specific regulated practices and processes. One such product, from my previous experience, is a Learning Management System. The software provides the...
Maintaining a Validated GMP Automation System

Maintaining a Validated GMP Automation System

Congratulations … the new automation system has been successfully validated. Regardless of the validation methodology employed, the Project Team has invested countless hours completing the validation, employing the system into its Operational Phase of a system Life...
Conducting Due Diligence Audits

Conducting Due Diligence Audits

There is a rising tendency within the Life Sciences industry, particularly within pharmaceutical manufacturing, to partner with contract manufacturing organizations (CMOs) to provide a particular segment/niche within their product manufacture and/or project timeline....
The Drug Supply Chain Security Act Summary

The Drug Supply Chain Security Act Summary

This article, provided by Regina Fullin, Sr. Compliance/Validation Consultant from Compliance Team, Inc., provides an executive summary of the FDA Drug Supply Chain Security Act (DSCSA), passed into law to address a growing problem with counterfeit products which are...