Electronic Device History Record (eDHR) Software

Software to Automate Electronic Device History Record eDHR and Electronic Device Master Record eDMR to Comply with 21 CFR Part 820 and 21 CFR Part 11

The FDA's Quality System Regulation (21 CFR Part 820) requires medical device manufacturers to establish and maintain device history record for each batch, lot, and unit they produce. The DHR 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.

When medical device manufacturers use electronic eDHRs, they must also comply with 21 CFR Part 11 requirements pertaining to electronic records and signatures.

MasterControl Process™ and Documents™ Software for Automating Electronic Device History Record eDHR and Electronic Device Master Record eDMR

Many of our FDA-regulated customers rely on MasterControl Process™ to automate the process of collecting and controlling data critical to compliance. MasterControl Process™ offers the flexibility in terms of design, routing, and user and security roles. It provides advanced tracking functionality, incorporates escalation, and offers best-practice features that prompt users with selected data to reduce data entry and avoid mistakes common in manual data entry. Data captured on forms is automatically entered in the MasterControl database, and can be used for analysis.

MasterControl Process™' robust features make it an ideal solution for managing electronic device history records eDHR. Furthermore, use of MasterControl Documents simplifies managing and maintaining the device master record (DMR).

Here's how MasterControl Process™ addresses some of the major challenges that companies face in establishing and maintaining forms-based processes.

Forms Automation Challenges		MasterControl Process™ Software - Automate Electronic Device History Record eDHR
Inefficient Paper Forms System A paper-based forms process can be plagued with inefficiency and such issues as: filling out the wrong form, not completing the right form, and sending the form to the wrong person.		Cost-Effective eAutomation System MasterControl Forms automates any forms-based process and offers best-practice features that prompt users with selected data. It automates routing, notification, escalation, and approval for faster turnaround. MasterControl is Web-based, so employees, customers, and suppliers can participate in forms-based processes (i.e., data input and verification) from virtually anywhere.
Poor Data Capture Forms are designed to gather accurate and complete information critical in compliance. With paper forms, the onus lies with the operator to input accurate and complete information, and then for an analyst to accurately transfer this information to a spreadsheet or other analysis tool.		Accurate Data Capture In creating new forms or improving existing ones, companies can use a variety of field formats for accurate and accelerated data collection. With a click of a mouse, a user can select common responses keyed in the form fields that allow a list of data options previously entered. 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.
Disconnected Processes Manual systems don't connect forms-based processes (audit findings, corrective action, etc.), making continuous improvement almost impossible. For example, if the deviation process not linked to the device history record, corrective action process, a critical complaint may languish indefinitely before it can be acted upon and remediation is initiated.		Connected Processes MasterControl integrates different quality processes for a more effective and efficient quality management. For example, a deviation or non-conformance can be launched directly from the device history record (DHR), reducing data entry and avoiding mistakes common in manual transfer of information.

Features

Here are some of MasterControl Process™ powerful features:

Efficient Forms: MasterControl automates any forms-based process, including routing, notification, escalation, and approval.

• Routes can be created based on a company's unique needs. For example, forms can be routed for data entry/data collection and approval. MasterControl incorporates escalation of overdue tasks. System administrators can easily create a variety of individually tailored user and security roles.

• MasterControl Process™ is Web-based so employees, customers, vendors, and others involved in forms-based processes can perform their tasks from virtually anywhere. Provides a centralized repository for easy access, search, and retrieval of forms by all authorized users.

• MasterControl tracks forms by status or history. A form will show as either "in process" or "complete" if tracked by status.

• Completed forms are indexed and stored, so users can search and report on the contents of the form.

• DHR review is simplified by automatically routing the DHR to the reviewing authority upon its completion.

• Forms can be signed and approved electronically. A signature manifestation including name, date, time, and meaning of electronic signature can be appended automatically to each form. MasterControl's electronic signature features comply with the FDA's 21 CFR Part 11 requirements.

Flexible Form Design: Forms created in Microsoft Word, Excel, or PowerPoint can be converted to PDF as is, so end users will see the same form and won't need new training. A company may also improve existing forms or design new ones to suit its needs using HTML and PDF design tools.

Offline Forms : Off-site and traveling users or external parties (customers, vendors) can complete forms and stay in the loop even without being connected to the MasterControl system. They can complete forms offline and then upload.

Form-to-Form Launching : A form can be launched directly from another form, connecting one process to the next. Not only does MasterControl streamline this process, but it also maintains the links so one can review a completed process and easily see what triggered that process.

Streamlined Performer/Witness Signoff: A process step can be configured to allow two people to sign off from a single screen. This is 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.

Conditional Routing: Forms can be routed to different users depending on data entered into the form. For example, a complaint can be routed to the appropriate product team by selecting the product from a drop-down field.

Supervisor Route: Many forms-based processes require approval by a supervisor no matter who initiates the process. With MasterControl, you can add the "supervisor" to forms routes. It can also be added in succession, so the route will move from a supervisor to that person's supervisor, and so on, along the hierarchy.

Analytics and Reporting: Data captured on forms is automatically entered in the MasterControl database. Companies can use built-in tools to filter the data, and then chart results for instant analysis. MasterControl's advanced analytics and reporting capability provides standard and customized reports to help increase management oversight.

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