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Electronic Device History Record (eDHR) Software Systems

The FDA's Quality System Regulation (21 CFR Part 820) requires medical device manufacturers to establish and maintain device history records for each batch, lot, and unit they produce. The eDHR software is a compilation of all records pertaining to the production of a finished medical device. It entails extensive documentation that includes dates of manufacture, quantity manufactured and when they were released, acceptance records to show that the device was produced according to device master records (DMR), identification labeling, and device identification and lot numbers.


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Produktinformationen

Discover how MasterControl eDHR Software can manage your eDHR process, all while mitigating risk, improving speed-to-market, and generating ROI.

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Fragen und Antworten
  • Was müssen Sie über Compliance mit 21 CFR 820 und ISO 13485 wissen? In dieser informativen Zusammenfassung mit Fragen und Antworten wird erklärt, was diese Normen beinhalten, für wen sie gelten, wie sie miteinander verknüpft sind und vieles mehr.

Demos & Toolkits

Get in-depth, comprehensive resources to guide development of your eDHR program.

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Interaktive und Live-Demonstrationen
  • Das Qualitätsmanagementsystem (QMS) von MasterControl bietet eine breite Palette an Softwarelösungen für Qualitätsmanagement, Dokumentenlenkung, Produktlebenszyklusmanagement, Lieferantenmanagement, Auditmanagement, Schulungsmanagement und weitere, auf Ihre Unternehmensbedürfnisse abgestimmten Lösungen. Dieser Überblick zeigt, wie Sie mit dem QMS von MasterControl Abfall vermeiden, Audits vereinfachen und die Einhaltung behördlicher Vorschriften erleichtern.
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Toolkits

Educational Materials

Get insider information about the most relevant issues in eDHR today, and how to navigate and overcome the complexities of FDA and ISO Compliance.

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White Paper
  • Dieses Whitepaper gibt einen knappen Überblick über ISO 13485 und untersucht, wie die Erlangung einer Zertifizierung nach diesem Standard den Weg für bisher ungenutzte geschäftliche Möglichkeiten im In- und Ausland ebenen kann. Zudem wird erläutert, wie ein Unternehmen vermeiden kann, einer der 50 Gerätehersteller zu werden, die aufgrund mangelhafter manueller Prozesse keine erneute Zertifizierung erlangen.
  • Da die meisten Medizingerätehersteller sowohl die Norm 21 CFR 820 QSR als auch ISO 13485 beachten müssen, ist es sinnvoll, die Einrichtung eines integrierten Qualitätsmanagementsystems (QMS) für 21 CFR 820 und ISO 13485 in Betracht zu ziehen. In diesem Whitepaper werden die Schnittpunkte dieser regulatorischen Anforderungen erläutert. Zudem enthält es wertvolle Informationen über Dokument-Benennungs- und Nummerierungsstrategien für eine bessere Compliance.
Produktdatenblätter
E-Book
  • Seit dem Jahr 2000 profitieren wir in Bezug auf regulatorische Compliance von unserem technologiegetriebenen Zeitalter. Dieses E-Book führt 16 Gesetze und Initiativen auf, die die Modernisierung mit vorangetrieben haben. Es ergründet, wie sowohl Aufsicht unterliegende Unternehmen als auch Regulierungsbehörden im vergangenen Jahrzehnt durch die Nutzung von Technologie Compliance vereinfachen und damit verbundene Kosten senken konnten.

Educational Materials

Analyst Report
  • Diese Studie zeigt, dass Unternehmen sich zu Recht auf das Risikomanagement und die Risikoanalyse konzentrieren, die angewendeten Prozesse und Verfahrensweisen jedoch möglicherweise unvollständig sind. Erfahren Sie, wie Sie Stolpersteinen ausweichen und dafür sorgen, dass Ihr Unternehmen die Qualität, den Betrieb und die Finanzkennzahlen erheblich verbessern kann.


MasterControl Process and Documents Modules are Ideal eDMR and Electronic Device History Record Software Systems


Complying with FDA, ISO and CGmP requirements is mandatory for medical device manufacturers whenever they use electronic eDHR software. Paper-based and legacy systems can't keep up with the rapidly changing business demands of the current market. It is extremely important to have a comprehensive system that can completely collect and control all the data that is critical for compliance.

MasterControl eDHR software systems provide an online platform for designing, managing, and controlling device history record files that are dependent on inputs from several sources. With MasterControl, medical device manufacturers can migrate from their highly error-prone paper forms system to an automated, dependable system. Problems like incorrect or duplicate data entry and similar inefficiencies become a thing of the past. The MasterControl Process™ software solution automates the electronic device history system for faster turnaround by providing best-practice forms for effective routing, notification, escalation, and approval.

The majority of medical device manufacturers today face the challenge of poor data capture, which usually leads to incorrect analysis and decisions that inadvertently have a negative effect the state of the business. MasterControl eDHR software systems provide highly customizable forms for securely capturing and entering data and all information vital for compliance. For example, users can select common responses keyed into form fields that allow a list of previously entered data options. This helps ensure data is entered correctly into the form. Fields can also be set up to calculate data using simple or complex math operations to validate values entered into the fields. MasterControl Documents™ enables companies to maintain device master records (DMRs) efficiently since it allows the same entered data to be automatically directed to other quality processes such as CAPA, deviance, non-conformance, etc., allowing management to have transparent oversight into a connected pool of processes.


MasterControl eDHR Software Systems Provide Fully Compliant Forms


In order to remain competitive in the market, many medical device manufacturers choose to buy and implement compliant eDHR software systems in their existing business and procedures. Their primary objective is to develop standard operating procedures that are compliant with FDA requirements such as 21 CFR Part 11. This requirement highlights the capability of electronic device history record software systems to provide forms that accommodate their business requirements.

To streamline connectivity, forms can be made dependent on each other via links. A process step can also be configured in the electronic device history record software to allow two people to sign off from a single screen. This may be necessary for tasks that require a witness during completion (e.g., electronic batch records) and eliminates the need for one user to log out and another to log back in so the second signature can be committed. In addition, because it is Web-based, the MasterControl system can be accessed from virtually anywhere in the world. To accommodate off-site users, third-party vendors, and similar users, MasterControl allows data to be collected through offline forms which is then uploaded and synced with data on the online portal as soon as the user goes online.

MasterControl eDHR software systems allow companies to take advantage of advanced analytics and customizable reports. Eventually, companies are not only able to attain but also sustain compliance that is based on connectivity and cross-collaboration between users and processes across the enterprise.

To Learn More About Electronic Device History Record (eDHR) Software Systems


To learn more about electronic device history record (eDHR) software systems, please feel free to contact a MasterControl representative.

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