AODocs for Life Sciences Now Delivers Advanced QMS Capabilities for Highly Regulated Enterprises
Modern and Intuitive Quality Management System Features Continuous Validation Framework Designed to Elevate Quality Assurance, Patient and Product Safety, and Data Integrity
AODocs, one of the fastest-growing content services platform providers, announced the latest edition of AODocs for Life Sciences, a modern cloud-native quality management solution (QMS) designed to accelerate the delivery of business solutions for FDA-regulated companies.
With this new update, AODocs for Life Sciences delivers enhanced capabilities for document control, change management, training and acknowledgment, management of corrective and preventative actions (CAPAs), and audit management. The latest release also features capabilities for managing non-conformities, customer complaints, governance and retention, reporting and analytics, and more.
AODocs for Life Sciences is a QMS that medical device manufacturers, pharmaceutical companies, and other research organizations can leverage to confidently build and administer their quality program, reduce the cost of computer system validation & assurance (CSV&A), and provide traceability during audits. The AODocs QMS framework, which is based on ISO 9001:2015, GAMP5, ASTM E2500, FDA 21 CFR Part 11, and EudraLex Annex 11, enables enterprises to deliver managed services that meets and exceeds the expectations of regulatory agencies in the U.S., Europe, and Japan.
“This year has dramatically illustrated the need for agility in the life science industry, and the importance of medical devices and drug manufacturers being able to react quickly to new situations and put their products to market in record time,” said AODocs CEO, Stéphan Donzé. “Quality management systems are a critical and foundational component of the IT stack for life science organizations, and AODocs for Life Sciences provides them with a flexible and easy to deploy SaaS platform to control their quality documents and business processes that can be deployed in weeks, not months or years.”
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AODocs for Life Sciences employs a continuous validation approach to alleviate time and challenges often involved with meeting validation requirements, and helps to provide the path to a smooth, secure, and compliant move to the cloud.
“Cloud solutions must be validated for life sciences companies to use them, and every time a cloud vendor makes an update to their software, it needs to be re-validated. Unfortunately, many life science firms still conduct validation testing manually, which is time consuming and prone to error. AODocs leverages a ‘Continuous Validation’ framework to mitigate these risks and ensure that AODocs libraries and applications are maintained in a validated state,” added Donzé.
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