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Summary
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adWatch PCM is designed to be flexible, scalable and easy-to-use.
The centerpiece of adWatch - PCM is meta-information -- by document. The user is given all relevant information about an adverse event in the way the authoring, editing and filing process is performed - step by step, action by action -- all summarized in one location. More detailed information about any document is immediately available via imbedded views.
adWatch - PCM has been designed with deliberate simplicity, mirroring the workflow of the product complaint management and safety organizations. A consistent user interface across multiple platforms, coupled with extensive on-line help, makes adWatch - PCM intuitively easy to learn and use.
Navigation within the adWatch - PCM system is simple. The design of the integrated modules leads the user through steps to click on buttons or icons that automatically forwards them through the appropriate workflow.
adWatch - PCM employs user-controlled tables for almost every checklist-driven entry. Modification of checklists and tables are under the control of the clinical database administrator, not the IT staff.
With Lotus Notes/Domino's technology, remote and mobile users can personally manage product complaint information using their laptop. Later, new and/or updated information is easily and efficiently replicated to the corporate adWatch - PCM database.
adWatch - PCM is extremely flexible. It can easily be adapted and customized to meet specific user needs and organization characteristics.
adWatch - PCM is scalable. It can serve a single location or an entire enterprise with global sites. Through replication, data can be synchronized across large organizations.
adWatch - PCM has been tested with a wide variety of other applications to further extend its power to other critical functions within the organization. These include: graphics, video, sound, word processing, spread sheets, management reporting, and other database managers -- Oracle, DB2, SAS, included.
To request a demo,
Click here.
To download the brochure,
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Features and Benefits
Complaint Entry and Analysis adWATCH-e mirrors the workflow of complaint processing from initial notification through investigation, analysis, and resolution.
Automated Adverse Event Reporting adWATCH-e automatically generates the FDA-approved MedWatch, Baseline, and CIOMS reports from information already in the database. Reports are seamlessly integrated to increase efficiency and accuracy of data.
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-e 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-e 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 complaint 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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