Electronic Batch Records (EBR) Software System
Software System to Automate 21 CFR Part 11 Compliant Electronic Batch Record (EBR) Processes in Pharmaceutical Enviornments to Meet FDA 21 CFR Part 211 CGMP Requirements
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. Since then, more and more manufacturers have recognized the advantages of automating the process of controlling Electronic Batch Records (EBR).
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 Electronic Batch Record EBR 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 meets all Part 11 requirements, including time-stamped audit trail, reporting, electronic signature, and security requirements.
MasterControl Electronic Batch Records™, 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 Forms™ to automate the process of collecting and controlling data critical to compliance like in the management of electronic batch records EBR. MasterControl Forms 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 an SQL database, and can be used for analysis.
MasterControl Forms' robust features make it an ideal solution for managing electronic batch record.
Here's how MasterControl Forms addresses some of the major challenges that companies face in establishing and maintaining forms-based processes.
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MasterControl Forms™ Software - Automate Electronic Batch Records and Other CGMP Processes |
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Inefficient Paper Forms System
A paper-based forms process like electronic 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.
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Cost-Effective eAutomation System
MasterControl Forms 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 is Web-based, so virtually anyone you specify can participate in forms-based processes (i.e., data input and verification) from virtually anywhere.
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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.
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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. |
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Disconnected Processes
Manual systems don't connect forms-based processes (audit findings, corrective action, etc.), making continuous improvement almost impossible. 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.
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Connected Processes
MasterControl 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.
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Here are some of MasterControl Forms' powerful features:
Efficient Forms: MasterControl automates any forms-based process, including routing, notification, escalation, and approval.
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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.
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MasterControl Forms 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.
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MasterControl tracks forms by status or history. A document will show as either "in process" or "complete" if tracked by status. The revision or approval history of documents can also be reviewed using the history feature.
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Completed forms are indexed and stored, so users can search on the contents of the form.
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Forms can be signed and approved electronically. Signature manifestation ? name, date, time, and meaning of electronic signature ? can be appended automatically to each document. 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.
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.
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.
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 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. |
