adWATCH - Corrective and Preventive Action (CAPA) helps organizations capture, distribute, retrieve, and manage corrective action requests and preventive action requests globally and in real-time.
The objective of Atlant Systems' atWATCH-CAPA Corrective and Preventive Action system is to help organizations capture, distribute, retrieve, and manage quality issues globally -- quality issues from any manual source, computer source or application. atWATCH-CAPA fosters an environment where document creation, review, and approval can be done collaboratively among individuals within and outside the corporation all over the world.
atWATCH-CAPA helps a pharmaceutical and/or medical device company:
- Receive, review and evaluate quality issues and corrective/preventive action requests from customers, physicians, patients, distributors, and other organizations as well as other locations within the company -- in-process, receiving inspection, finished goods, material review boards.
- Process and document investigations of quality issues by the respective manufacturing site(s)
- Resolve quality issues including the corrective and preventive actions necessary to meet customer service goals
- Track all open quality issues to ensure timely resolution and action
- Enforce an approval process for each CAPA entry that complies both with company and regulatory requirements
- Provide access to the CAPA management system by all authorized users inside and outside the organization
- Archive CAPA and related documents electronically for rapid search and retrieval
- Deliver ad hoc reporting to management for trend evaluation and statistical analysis
Features and Benefits
- atWATCH - CAPA accepts corrective and preventive action requests from a product complaint system as well as a company's ERP system.
- atWATCH - CAPA allows remote users to participate in many functions of the system via dial-up, intranet, or extranet.
- atWATCH – PCM mirrors the workflow of CAPA processing from initial notification through investigation, analysis, and resolution.
- atWATCH - CAPA provides the ability to respond quickly to product, assembly, sub-assembly, and raw materials quality issues by providing timely customer feedback.
- atWATCH - CAPA includes a software validation database to assist with FDA-mandated requirements for initial validation and change control procedures.
- Enterprise-wide replication ensures up-to-the-minute information is available across all locations, worldwide
- An intuitive look and feel to screens makes using atWATCH - CAPA simple and easy to use.
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