FDA ready for electronic reports

TrackWise eMDR Submission Manager software, an add-on for TrackWise, lets companies electronically submit Medical-Device Reports (MDRs) to the FDA. The software electronically tracks and manages product complaint and adverse-event assessment and reporting processes. The software lets companies manage complaints and investigations, assess potential adverse events for safety risk problems, and comply with health authority reporting requirements, including those of FDA.

FDA regulations require that firms notify the organization when the company receives complaints that its devices malfunction or cause serious injury or death. Manufacturers are required to submit an individual adverse event report (MDR Report) to FDA using its 3500A form. TrackWise customers currently produce 3500A reports in electronic form, from structured audit-trailed data fields. Sparta's 3500A report has been previously approved by both FDA's Center for Devices and Radiological Health (CDRH) and Center for Drug Evaluation and Research (CDER).

To streamline delivery of 3500A reports, FDA is now implementing an electronic submission program called “eMDR.” Under this program, FDA receives electronic submissions of MDRs by the FDA Gateway, a secure agency-wide entry point for all electronic submissions. Using this approach, medical-device manufacturers can issue reports electronically, eliminating costs and errors associated with paper-based reporting processes.

Sparta Systems Inc., 2137 Highway 35, Holmdel, NJ 07733, (888) 261-5948, info.ims.ca/6949-250
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Complying by Web

CompliantPro for medical-device manufacturers lets design teams comply with the FDA's QSR requirements, ISO 13485, and ISO 14971. The software includes integrated Corrective and Preventative Actions (CAPA) capabilities, document control, enterprise risk management assessment, and environmental, health, and safety management. The software also includes advanced product quality planning, and incident reporting that complies with the FDA's requirements for MDRs and Corrections and Removals.

IBS America Inc., 125 Hartwell Ave., Lexington, MA 02421, (781) 862-9002, info.ims.ca/6949-251
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Adapter lets software work with Oracle applications

The SmartConnector is an Oracle Applications adaptor for the Oracle e-Business Suite. SmartConnector lets companies that use Pilgrim's SmartSolve software integrate those programs with any Oracle application through an intuitive visual environment. There's no need for end-user programming or to modify existing Oracle programs. The adapter lets users easily perform complex integrations. The SmartConnector uses Oracle Call Interface technology and supports bi-directional, synchronous, or asynchronous connections between Oracle e-Business Suite applications and SmartSolve.

Pilgrim Software Inc., 2807 W. Busch Blvd., Suite 200, Tampa, FL 33618, (813) 915-1663, info.ims.ca/6949-252
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Reduce CAPAs by assessing and managing risk

A stand-alone Risk Assessment module lets users configure and integrate risk-based assessment tables within all of EtQ's modules, or as an independent risk event. Users create risk assessment templates, with tables and charts to identify severity, frequency, or other risk-based criteria. Templates can be used for an independent risk-assessment event, and can be linked to modules within the EtQ Quality Management System. The resulting tool calculates the risk of quality events at every step of the process, improving overall quality, and reducing recurrence of critical events. As an example, EtQ uses the Risk Assessment module with Corrective Action and Preventive Action (CAPA) to minimize the number of CAPAs that enter a Quality System.

EtQ Inc., 399 Conklin St., Suite 208, Farmingdale, NY 11735, (800) 354-4476, info.ims.ca/6949-253
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