Software zur Nachverfolgung der Produktregistrierung medizinischer Geräte

 


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Architektur und Technologie


Die Produktregistrierungslösung TrackWise macht den gesamten Lebenszyklus der Produktregistrierung im gesamten Unternehmen vollkommen transparent. Nachverfolgung von Aktivitäten der Regulatory Affairs über mehrere Standorte und Niederlassungen hinweg.

Automatische Überwachung aller behördlichen Einreichungen sowie entsprechender Korrespondenz und Verpflichtungen. Rasche Anpassung an sich weltweit verändernde Verordnungen dank einfacher Point-and-Click-Konfiguration. Bessere Sichtbarkeit sämtlicher Produktinformationen für strategische Geschäfts- und Compliance-Entscheidungen. Hier erfahren Sie mehr zu diesem Thema: Verfolgung von Produktzulassungen mit TrackWise Datenblatt.

Integration von Software zur Nachverfolgung medizinischer Geräte im Unternehmen TrackWise, das System zur Nachverfolgung für Produktregistrierungen , ermöglicht es Herstellern von medizinischen Geräten, den Aufwand sowie Kosten und Risiken des Registrierungsprozesses signifikant zu reduzieren. Technologie zur globalen Nachverfolgung medizinischer Geräte TrackWise optimiert die Verwaltung des Produktlebenszyklus für jede Registrierung, in jedem Land, für jedes Produkt, jeden Verwendungszweck, jede Konfiguration, jedes Kit sowie die entsprechende Etikettierung.

Diese Website nutzt Cookies, um bestmögliche Funktionalität bieten zu können. Durch die weitere Nutzung der Seite stimmst du der Verwendung von Cookies zu. MasterControl's customer complaints tracking software connects the customer-complaint process to the rest of the quality system, providing links to corrective actions and adverse-event handling. Via an external link, customers can integrate MasterControl Customer Complaints with other computer systems.

For example, a link can be provided on a company Web site, within a CRM application or any application that supports URL links , so employees, customers, or partners can easily initiate a customer complaint. Connectivity will help managers track a complaint from initiation to completion and give them the ability to proactively improve the complaint-handling process. In a manual system, record keeping may be inadequate for the purpose of answering a product liability lawsuit.

Without a customer complaints tracking system, managers don't have the ability to track complaints and see the compliance program as a whole, both of which are essential in developing a strategy for preventing unwarranted legal exposure. MasterControl provides advanced reporting capabilities for real-time view of the state of a company's compliance. The customer complaints tracking software allows continuous monitoring and promotes improvement, both of which can help increase a company's readiness to answer any possible lawsuit.

A controlled record-keeping environment that shows how complaints are investigated and addressed may help reduce legal exposure. A manual system is plagued by bottlenecks: All of these can result in delayed complaint resolution. Customer complaints tracking software by MasterControl will reduce the life cycle of the complaint process by streamlining different steps and consolidating different sources of complaints under a single platform. It provides a customizable form that captures all necessary information, provides automatic follow-up via e-mail notification, and incorporates escalation to ensure timely response.

MasterControl customer complaints tracking software is a robust software solution that manages complaint handling more efficiently and effectively with the help of the following features:.

Additional forms can be customized according to a company's special needs. Compliant System - 21 CFR Part 11 requires an audit trail as a key control in making electronic records reliable. MasterControl maintains a secure, time-stamped audit trail within the customer complaints tracking software that documents the identity of anyone who creates, modifies, or deletes an electronic record such as a customer complaint file , when the action occurred, and the changes made to the record.

MasterControl meets FDA requirements for electronic signature and software validation. Analytics and Reporting Tool - MasterControl's advanced reporting capabilities available in the customer complaints tracking systems increase management oversight and demonstrate appropriate controls to regulatory agencies.

The solution includes the following customizable reports:. CAPA Integration - MasterControl's customer complaint tracking software gives you the option to integrate customer-complaint handling with the corrective and preventive action CAPA process to automatically escalate any serious quality problem.

Sustained Compliance - Regulated companies cannot ignore customer complaints. Every complaint has to be properly evaluated, investigated, and the situation, corrected. MasterControl customer complaints tracking system is designed to streamline and simplify the complaint process, foster efficiency throughout the enterprise, and keep compliance costs down.

With MasterControl, you can count on a partner that will support your compliance efforts over the long haul. For more information about complaint handling or customer complaint tracking software systems, please feel free to contact a MasterControl representative. Unternehmensinfo Wer sind wir? Kostenlose Ressourcen herunterladen Produktdatenblatt: Customer Complaint Tracking Software Systems: The MasterControl Solution MasterControl's software suite collects and securely stores all documentation pertaining to the complaints a company receives.

Here's how it can answer key challenges in the customer complaint process: Customer Complaints Handling Challenges MasterControl Customer Complaints Software Solution Different Sources In a manual customer complaint tracking system, customer complaints may come from different sources e-mail, phone, fax, letters, corporate Web site, sales reps, etc. Centralized Source It provides a secure and centralized platform for receiving customer complaints and then tracking and storing all subsequent documentation pertaining to investigation and correction of the problem.

Disconnected Processes When a company uses different tools that are not connected, tracking complaints and follow-up work can be a major obstacle.