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adWATCH - AE meets the government's requirements for 21 CFR Part 11 and HIPAA.
Winchester's systems engineering experience provides the perfect foundation on which to build dependable, consistent, secure, accurate and attributable Internet-based applications conforming to all GCP requirements for Data Integrity, System Reliability, Management Control, and Auditable Quality. adWATCH-PCM is designed to be in full compliance with International Conference on Harmonization and Good Clinical Practices (ICH-GCP), 21 CFR Part 11 Electronic Record and electronic signatures and FDA's "Guidance: Computerized Systems Used in Clinical Trial."
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Features and Benefits
adWATCH - AE mirrors the workflow of complaint processing from initial notification through investigation, analysis, and resolution.
adWATCH - AE automatically generates the FDA-approved MedWatch, Baseline, and CIOMS reports from information already in the database.
The Customer Notification forms letter library provides the ability to send customized letters at predetermined times or on an as-needed basis during the investigation and resolution.
adWATCH - AE provides the ability to respond quickly to product quality issues by providing timely customer feedback.
adWATCH - AE 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
adWATCH - AE allows remote users to participate in many functions of the system via dial-up, intranet, or extranet.
An intuitive look and feel to screens makes using adWATCH - AE simple and easy to use.
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