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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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Informations sur le produit

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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Questions-réponses
  • Ce que vous devez savoir à propos de la conformité à la partie 820 du titre 21 du CFR et à la norme ISO 13485. Ce résumé informatif, présenté sous forme de questions-réponses, vous explique en quoi consistent ces normes, à qui elles s'appliquent, leurs liens, et bien plus.

Demos & Toolkits

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

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Démonstrations interactives et en direct
  • Le système de gestion de la qualité (QMS) de MasterControl fournit un large éventail de solutions logicielles facilitant la gestion de la qualité, des documents, du cycle de vie des produits, des fournisseurs, des audits, des formations, et bien plus, selon les besoins de votre entreprise. Cette démonstration montre comment le QMS de MasterControl élimine les gaspillages, simplifie les audits et facilite la conformité règlementaire.
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Kits d'outils

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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Livres blancs
  • Ce livre blanc fournit un récapitulatif concis de la norme ISO 13485 et montre les opportunités commerciales que l'obtention de cette certification peut offrir, à l'échelle nationale et internationale. Il explique également comment éviter de faire partie des 50 % de fabricants de dispositifs certifiés qui ne parviennent pas à obtenir le renouvellement de leur certification en raison de processus manuels inadaptés.
  • Pour la plupart, les fabricants de dispositifs médicaux doivent se conformer à la partie 820 du titre 21 du CFR et aux normes ISO 13485. Par conséquent, ils ont tout intérêt à mettre en place un système de gestion de la qualité intégrant ces règlementations et normes. Ce livre blanc identifie les points de convergence de ces exigences règlementaires et fournit des informations précieuses sur les stratégies de numérotation et de nommage des documents à adopter pour renforcer la conformité.
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Livre électronique
  • Depuis 2000, la conformité règlementaire s'est modernisée grâce à l'essor des nouvelles technologies. Ce livre électronique identifie 16 lois et initiatives qui ont contribué à cette évolution. Il décrit l'impact de la technologie sur l'amélioration sur les deux plans, tant les entreprises que les agences réglementées, afin de réduire les difficultés et les coûts liés à la mise en conformité, au cours de la dernière décennie.

Educational Materials

Analyst Report
  • Cette étude montre que les entreprises ont raison de s'intéresser à l'analyse et à la gestion des risques, mais que leurs processus et leurs pratiques ne sont pas suffisamment complets. Découvrez quels sont les écueils à éviter et comment aider votre entreprise à améliorer significativement la qualité, les opérations et les résultats.


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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