Our on-site validation service can enable you meet global regulatory requirements and help you reduce your compliance risk.

This 2-day course guides attendees through equipment qualification, calibration and computer system validation processes from planning to reporting.

Design qualification based on user requirements; Qualification based on design specifications and installation requirements of manufacturer; Operation ...

This online course describes regulatory requirements and expectations regarding the validation and compliance of computerized systems used in the ...

USDM has experience qualifying, verifying, and validating the myriad systems, equipment, and processes that are found in most life sciences GxP environments, ...

This course is designed for those who perform, supervise, manage, audit, or oversee the validation of test methods in labs that support cGMP, GLP, and other ...

Mar 25, 2024 · The validation team is responsible for establishing and maintaining computer validation programs, developing and approving computer validation ...

Aug 28, 2023 · Computer System Validation (CSV) emerges as a critical process to ensure that these computerized systems are designed, implemented, and ...

Computer systems validation (CSV) is a critical requirement of electronic record and system compliance, as described in the FDA 21 CFR 11.10(a) and EMA Annex 11 ...

Performance qualification (also referred to as “user requirement testing”) confirms that the software will meet the user's needs and is suitable for their ...