- PILOT:EBR - Electronic Batch Record
PILOT:EBR - Electronic Batch Record (EBR) to digitize pharmaceutical production
Using PILOT:EBR for the Electronic Batch Record Management, pharmaceutical companies take a great step towards full digitization of their production. PILOT:EBR provides a complete electronic and GMP-compliant process from formula generation to weighing and validation of production data up to the comprehensive documentation including batch logs. All regulatory rules and requirements, such as FDA, EMA, AMG, cGxP, etc. are integrated.
The Master Batch Record (MBR) is the basis of all manufacturing instructions integrating the generation and management of formulas according to the ISA-95/ISA-88 standards. This includes, for example, the definition of workflows, general conditions, equipment and quality requirements. This information is then used for all following operative processes like weighing, dosing, validation of production data and collection of further data. PILOT:EBR documents all manufacturing steps based on the MBR. One of the numerous benefits is the simple batch inspection and release. You can also integrate LIMS, building or process control systems and other systems via the relevant interfaces.
- Multifunctional terminal
Multifunctional terminal instead of permanent system changes
In their working routine, employees often use different devices and fulfill their tasks using paper forms. This is different with the multifunctional terminal by FELTEN because all information a user requires for their work is in one place and on one GUI. As the information is entirely digital, paper documents are no longer needed.
Real-time data from the shop floor and ERP master data are bidirectionally communicated via the Pilot® platform. The ultra-modern web technology provides and displays this data for the user. Employees get the specific information they require for their job and are securely guided through the process.
The multifunctional terminal is available as stationary terminal or can be used with mobile devices. You can flexibly change design and contents and provide each employee with exactly the information required to efficiently prepare the next work steps. A graphic shows the current order or shift performance and thereby the target-actual comparison in production and motivates the staff to reach their targets.
You are free to configure any GUI for the employee. You can, for example, show the order information with current statuses and the relevant actual and target values. The GUI can also include the current machine status and all planned inspections, maintenances, product changes, etc. Even important KPIs can be added. The results of the last shift or the last few days can additionally be shown. And: a click can open all required documents, from material and product information up to work instructions or service manuals and maintenance videos.
PILOT:EBR - Electronic Batch Record (EBR) to digitize pharmaceutical production
Using PILOT:EBR for the Electronic Batch Record Management, pharmaceutical companies take a great step towards full digitization of their production. PILOT:EBR provides a complete electronic and GMP-compliant process from formula generation to weighing and validation of production data up to the comprehensive documentation including batch logs. All regulatory rules and requirements, such as FDA, EMA, AMG, cGxP, etc. are integrated.
The Master Batch Record (MBR) is the basis of all manufacturing instructions integrating the generation and management of formulas according to the ISA-95/ISA-88 standards. This includes, for example, the definition of workflows, general conditions, equipment and quality requirements. This information is then used for all following operative processes like weighing, dosing, validation of production data and collection of further data. PILOT:EBR documents all manufacturing steps based on the MBR. One of the numerous benefits is the simple batch inspection and release. You can also integrate LIMS, building or process control systems and other systems via the relevant interfaces.
Multifunctional terminal instead of permanent system changes
In their working routine, employees often use different devices and fulfill their tasks using paper forms. This is different with the multifunctional terminal by FELTEN because all information a user requires for their work is in one place and on one GUI. As the information is entirely digital, paper documents are no longer needed.
Real-time data from the shop floor and ERP master data are bidirectionally communicated via the Pilot® platform. The ultra-modern web technology provides and displays this data for the user. Employees get the specific information they require for their job and are securely guided through the process.
The multifunctional terminal is available as stationary terminal or can be used with mobile devices. You can flexibly change design and contents and provide each employee with exactly the information required to efficiently prepare the next work steps. A graphic shows the current order or shift performance and thereby the target-actual comparison in production and motivates the staff to reach their targets.
You are free to configure any GUI for the employee. You can, for example, show the order information with current statuses and the relevant actual and target values. The GUI can also include the current machine status and all planned inspections, maintenances, product changes, etc. Even important KPIs can be added. The results of the last shift or the last few days can additionally be shown. And: a click can open all required documents, from material and product information up to work instructions or service manuals and maintenance videos.