05.17.25 -- Industry-Leading Solutions For Quality Assurance And Compliance In Pharma

Approach for US FDA 21 CFR Part 11 electronic records and electronic signatures: IDBS PIMS has been designed, developed, and tested to enable compliance with 21 CFR Part 11 to accommodate regulatory needs.

Phase-specific quality standards in biopharmaceuticals ensure GMP compliance, and maintain data integrity. Experienced CDMOs help balance quality expectations with accelerated development timelines.

Each production line, container, and product has unique requirements. Explore how Körber tailors its inspection solutions to meet the individual needs of its customers with a wide range of inspection technologies.

Discover a line of validation products and services addressing different levels of validation needs based on individual risk assessment. They're designed to allow “continuous validation” for FDA-regulated companies.

Ensure regulatory compliance in life sciences with expert qualification services and a team that excels in equipment installation and use to provide comprehensive solutions to meet design and stakeholder requirements.

Uncover innovative monitoring solutions for aseptic filling processes to ensure sterility through equipment, environment, and product validation to optimize safety and regulatory compliance.