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.
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.
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, please feel free to contact a MasterControl representative.