Pharmaceutical companies have traditionally used paper (hard copy) to maintain production batch records (PBR), also called master production batch records (MPBR), for FDA-compliance purposes. With the advent of 21 CFR Part 11 in 1997, the FDA began to accept electronic batch records systems. Since then, more and more manufacturers have recognized the advantages of automating the process of controlling batch records.
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Under CGMP regulations found in 21 CFR Parts 210-211, the electronic batch record (EBR) must demonstrate the accomplishment of every significant step in the production, packing, and holding of each batch of a drug product. CGxP requires extensive EBR System documentation, including batch dates, identity of major equipment/lines used, components/materials used and their weights, in-process and laboratory control results, complete labeling control records, sampling, and identification of personnel supervising or checking each step.
In addition to what CGMP requires, manufacturers that automate their PBR must do so in accordance with 21 CFR Part 11 requirements. MasterControl's EBR software meets all Part 11 requirements, including time-stamped audit trail, reporting, electronic signature, and security requirements.
MasterControl's electronic batch record software systems, designed based on the Instrumentation, Systems and Automation Society's S88 model (ISA-S88 or S88), is a powerful EBR management solution for automating and controlling batch processes.
Many of our FDA-regulated customers rely on MasterControl Process™ to automate the process of collecting and controlling data critical to compliance like in the management of electronic batch records system. 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 electronic forms is automatically entered in an SQL database, and can be used for analysis.
MasterControl Process' robust features make it an ideal solution for managing electronic batch record systems.
Here's how MasterControl Process addresses some of the major challenges that companies face in establishing and maintaining forms-based processes.
EBR Systems Automation Challenges
Batch Record Software Solutions
Inefficient Paper Forms System
A paper-based forms process like for batch records 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.
Poor Data Capture
Electronic batch records systems, controlled by the Process application, 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.
Manual systems don't connect forms-based processes (audit findings, corrective action, etc.), making continuous improvement almost impossible until an electronic batch records system is implemented. For example, if the customer complaint process is not linked to the corrective action process, a critical complaint may languish indefinitely before it can be acted upon and remediation is initiated.
Cost-Effective eAutomation System
MasterControl Process can automate batch record processes. It offers best-practice features that prompt users with selected data. It automates routing, notification, escalation, and approval for faster turnaround. MasterControl's electronic batch record software is a web-based solution, so virtually anyone you specify can participate in forms-based processes (i.e., data input and verification) from virtually anywhere.
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. MasterControl's electronic batch record software helps to ensure data is entered correctly into the form. Fields can also be set up to calculate data using simple or complex math operations.
MasterControl electronic batch records software integrates different quality processes for a more effective and efficient quality management. For example, a change submission form can be launched directly from a CAPA form, connecting one process to the next. Relevant information will be automatically entered into the new form, reducing data entry and avoiding mistakes common in manual transfer of information.
Here are some of MasterControl Process' powerful features:
Efficient Forms: MasterControl electronic batch record software automates any forms-based process, including routing, notification, escalation, and approval.
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.
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 EBR systems. 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 between the electronic batch records system, so one can review a completed process and easily see what triggered that process.
Document Approval via Forms: Some forms-based processes are so tightly connected with the document approval process, requiring the same signatures for both. With this feature, the process is streamlined. A form and the documents linked to it can be approved all at once, avoiding repetitive steps.
Conditional Routing: Quality-related tasks 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 from the EBR software.
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 a SQL database. Companies can use built-in tools of the EBR software 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.
To have a comprehensive knowledge about an electronic batch records (EBR) software system, feel free to contact MasterControl representative.