The life sciences industry is poised for a remarkable transformation where metrics-driven business processes and regulatory compliance (such as are FDA 21 CFR Part 11 and FDA Software Validation) are dominant factors for success. To sustain and flourish in this new environment, companies have to focus more than ever before on defining, monitoring and acting on the metrics that matter. This means managing operational risks, ensuring regulatory compliance, making quality a high priority issue and standardizing processes across the value chain, both internal and external.
An operational approach that takes into account both quality and compliance will provide organizations the capability to ensure reduced operational risks, prevent supply chain disruptions, eliminate quality failures and technology breakdowns – all while enabling them to go-to-market faster and seize new opportunities. With the situation changing significantly, so are the companies that operate within it.
In-house developed systems, stand-alone applications, and manually handled paper-based processes that manage quality and compliance at the unit level pose challenges. Such systems and processes lack a broad enterprise reach and are unable to scale effectively, while compliance costs rise, and the risk of non-compliance with FDA directives increases.
To help accomplish objectives organizations have for quality and safety management, ComplianceQuest (CQ) has designed Enterprise Quality and Safety Management System (EQMS+EHS) with a focus on quality, compliance, health and safety, collaboration & social capabilities.
21 CFR Part 606, 1271
