ZenQMS Partners with Sware to Simplify GxP Validation Across the Software Lifecycle

ZenQMS and Sware provide Life Sciences organizations with a modern, risk-based approach to validating ZenQMS implementations and ongoing software releases ARDMORE, PA, UNITED STATES, July 22, 2026 ...
Mena FN

Computer System Validation (CSV) Training Course: Regulations Impacting Your Systems And Hands-On Practice Writing Validation Documents (Jan 27Th - Jan 29Th, 2026 & On-Demand)

(MENAFN- GlobeNewsWire - Nasdaq) The main market opportunities include training on modern technologies for computer system validation, compliance with evolving FDA regulations, and risk-based ...
MD&M East

The Goldilocks Principle: Approaches to Software Validation

Software is a significant part of any modern manufacturing operation, and FDA requires validation of such software used for regulated processes. Companies are often confused, however, about when and ...
JD Supra

FDA’s Draft Computer Software Assurance Guidance Changes the Game for Quality System and Production Software Validation

On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
MD&M East

Validating Software as a Medical Device (SaMD)

Software in the healthcare industry has come a long way over the past 20 years. Medical device companies, like most life sciences companies, were a bit hesitant to incorporate software and automation ...