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The pharmaceutical industry requires compliance with Good Manufacturing Practices (GMP), data integrity requirements, and global regulatory frameworks. Against this backdrop, inspection readiness and audit...
Regulated industries have always been defined by strict documentation requirements, audit scrutiny, and an ever expanding library of records. As...
Whether just hearing the acronym QMS for the first time or evaluating software for small businesses, quality management systems are central to reliable operations and...
Between evolving AI frameworks, demand for higher-quality data, global policy shifts, and new approaches to manufacturing and supply resilience, companies...
We’re proud to announce a major milestone in PSC Software’s growth: we have achieved both ISO 9001 and ISO 27001 certifications. These two internationally recognized...
The latest revision of the Good Clinical Practice guideline, ICH E6 (R3), updates how clinical trial documentation should be managed, with new expectations for compliance....
Audits are a critical part of compliance for regulated industries, but traditional on-site inspections can be costly, time-consuming, and disruptive....
Australia and New Zealand are introducing changes that will significantly impact life sciences companies for 2026. Australia’s reforms include new...
Electronic Batch Records (EBRs) have become essential for modern pharmaceutical and life sciences manufacturing. While many systems promise compliance and...
As Asia’s life sciences regulatory landscape evolves in 2026, companies face significant changes that demand strategic preparation. India is piloting electronic Common...
The European Medicines Agency (EMA) is at the forefront of digital transformation in pharmaceutical regulation through its Digital Application Dataset Integration (DADI) project. This...
By incorporating ISO 13485:2016 principles and ISO 9000:2015 references, the FDA’s transition from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) aims to...
An Enterprise Quality Management System (eQMS) serves as the cornerstone for organizations striving to achieve excellence in quality and compliance, enabling businesses to make...
With increasing regulatory demands and the pressure to deliver high-quality products faster, companies are turning to smarter tools to help...
The global life sciences regulatory landscape is looking to undergo significant evolution in 2026. The UK’s Medicines for Human Use (Clinical Trials) Amendment Regulations 2025...
Traditional quality management approaches often rely on manual processes and paper-based systems, which can be inefficient, error-prone, and costly. Electronic...
In the upcoming year, across major North American jurisdictions, regulators are modernizing policies to accelerate innovation while strengthening safety and quality oversight. From...
In regulated industries such as life sciences, pharmaceuticals, and medical devices, quality management is a strategic necessity. Manual processes, paper-based systems,...
