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adwatch capa -- description.pdf
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 Winchester Business Systems' adWatch-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. adWatch-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.
adWatch-CAPA helps a pharmaceutical and/or medical device company:
Receive, review and evaluate quality issues and corrrective/preventive action requests from customers, physicians, patients, distributors, and other organizations as well as other locations within the company -- in-process, receiving inspection, finiched 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
To request a demo,
Click here.
To download a brochure,
Click Here
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Features and Benefits
adWatch - CAPA accepts corrective and preventive action requests from a product complaint system as well as a company's ERP system.
adWatch - CAPA allows remote users to participate in many functions of the system via dial-up, intranet, or extranet.
adWatch – PCM mirrors the workflow of CAPA processing from initial notification through investigation, analysis, and resolution.
adWatch - CAPA provides the ability to respond quickly to product, assembly, sub-assembly, and raw materials quality issues by providing timely customer feedback.
adWatch - 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 adWatch - CAPA simple and easy to use.
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