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adWatch - CAPA

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Summary		Compliance

adWATCH-CAPA strictly adheres to the guidlines set forth by the FDA regarding electronic documents and signatures for pharmaceutical, biotechnology, and medical device companies.

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-CAPA 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


	CAPA requests and Analysis adWATCH-CAPA mirrors the workflow of quality issue processing from initial notification through investigation, analysis, and resolution.
	Investigation Portal allows the sponsor to assign investigations to OEMs and Private Label companies to be performed over the web.
	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.
	Powerful merge-mail facility allows departments to send multiple customized letters.
	Corrective Action adWATCH-CAPA provides the ability to respond quickly to product quality issues by providing timely customer feedback. Electronic notification with Action Items to all departments is automatically generated.
	Software Validation adWATCH-CAPA includes a software validation database to assist with FDA-mandated requirements for initial validation and change control procedures.
	Global Access to Current information Customer Service, Quality Assurance, Regulatory Affairs, and Manufacturing have access to critical data as the corrective action request is being processed and resolved. Enterprise-wide replication ensures up-to-the-minute information is available across all locations, worldwide
	Electronic Records and Signatures adWATCH-e meets and exceeds the requirements for the FDA's 21 CFR Part 11.

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