INSIGHTS ON REGULATORY COMPLIANCE
-
Five Steps To Implementing CSA
Explore how the FDA’s CSA guidance simplifies computerized systems validation by emphasizing risk-based approaches, reducing documentation burdens, accelerating testing, and enhancing compliance.
-
Improving Productivity And Purity In ADC Polishing
Discover how a CDMO achieved 40x productivity and 15% cost savings by switching to rapid cycling membrane chromatography for ADC polishing, which helped cut process time and buffer use.
-
Exploring The Potential Of Agentic AI
Discover how agentic AI is poised to transform Enterprise Asset Management in regulated industries to enhance compliance, reduce downtime, and bridge fragmented systems for resilient operations.
-
Compressed Gas Contamination: Guidelines For Control In Aseptic Manufacturing
Explore key guidelines for preserving the purity and quality of compressed gas, with an emphasis on contaminants, monitoring, and preventive maintenance practices.
-
Why Perform A D-Value Study? Reference Review10/31/2024
Understanding how a product influences microorganisms' resistance is crucial. Read about relevant standards and references as well as recommendations for performing product D-value studies.
-
Overview Of Biological Indicator And Sterilization Monitoring Systems7/2/2024
Watch to explore the use and proper placement of biological indicators in hydrogen peroxide decontamination processes.
-
How Digital Procedures And E-Logbooks Are Transforming Manufacturing9/2/2025
Paper-based processes slow down life sciences manufacturing and introduce compliance risks. Discover how digital procedures and electronic logbooks can boost accuracy, speed, and traceability.
-
Validation Of A Sterilization Process: Part 29/9/2025
Gain essential insights into sterilization processes by exploring the Overkill method—an approach that ensures product safety through rigorous cycle development and validation.
-
Cleanroom Data Analytics For Setting Up Environmental Monitoring6/24/2025
Discover how digital integration enhances compliance, streamlines operations, and enables proactive planning for contamination control in pharmaceutical manufacturing
REGULATORY COMPLIANCE SOLUTIONS
-
Learn about Honeywell Manufacturing Excellence, a powerful platform built to accelerate innovation in life sciences manufacturing.
-
MasterControl’s audit management software system automates tasks so that companies can successfully pass audits.
-
Digital document control systems introduce automation into your processes. A digital solution is not only more efficient, it also makes it easier to keep up on regulatory changes and maintain compliance.
-
The Palltronic Flowstar V integrity test instrument ensures accurate filter integrity testing with a further reduction in test time, full compliance with 21 CFR Part 11, advanced automation capabilities, and simplified network integration saving the user time while improving process efficiency.
-
Explore cycle development and validation services and biological indicator testing services from an ISO-certified laboratory, registered with the FDA and DEA.