Electronic Batch Records

Electronic Batch Records

Challenges

1

Decision-making

Are your manager’s decisions based on the real-time data from the field?

2

Workforce Competence

Are your workers working according to FDA regulations and checklists, your processes and best practices?

3

Work Quality & Efficiency

Is work being performed efficiently and at a suitable level of quality?

4

EHS Conformance

Is work aligned with the relevant EHS guidelines and requirements?

5

Contractor Management

Facing problems tracking contractor performance and managing contractor budgets and schedules?

6

Multiple Systems

Forced to work with multiple systems to support different tasks and use cases?

7

Access to Data

Is your unique knowhow and data stored in diverse, often unstructured and forgotten systems?

Solution

The Mobideo Platform provides regulatory-compliant solutions that fill the gaps in manufacturing execution, including an EBR system our customers use to obtain FDA approval of their production processes. This automatization and digitalization of previous time-consuming manual documentation processes also delivers real-time visibility of the step-by-step actions performed by workers, resulting in:

Connected Workers

The Mobideo App enables operators to dynamically populate task content and digital checklists using any mobile device, including capturing and adding photographs, barcodes, and annotations. Moreover, the app ensures that inspectors focus solely on essential inspection tasks, tailored to standardized procedures and regulatory compliance. By eliminating boilerplate templates and one-size-fits-all checklists, operators can efficiently conduct inspections specific to the type of equipment being inspected, optimizing workflow and regulatory adherence.

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Connected Managers

The Mobideo Control Center turns both planned and unplanned activities into digitalized tasks and checklists that are dispatched to workers in the field. Enabling the real-time tracking of progress and compliance, it also supports the creation of unplanned activities generated in response to alerts/warnings displayed in real-time on digital wallcharts and dashboards; the automatic creation of EBR reports; and better decision-making and management of resources.

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Process Optimization

The Mobideo Optimizer captures all data from the Mobideo App and the Mobideo Control Center, generating a rich set of reliable EBR data available for immediate analysis and use in real-time digital wallcharts. This valuable data serves a range of purposes – such as KPI measurement, creation of real-time reports, evaluation of how EBR tasks are actually being executed, and identification of trends and work patterns – that drive continuous process improvement and strengthen operational excellence.

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Benefits

Identification and prevention of error

Early, real-time awareness and identification of issues and delays, allowing for resolution of events through the rapid deployment of corrective actions

Optimized field execution and increased productivity through real-time events and work plans, modifiable priorities and efficient resource allocation

Ensures workers are working according to FDA regulations and approved checklists, your processes, and best practices with tasks and relevant instructions available on any mobile device

Real-time visibility to managers, ensuring proactive, fast response and easier mitigation of EHS risks

Always know who did what, and when.

Paper-free environment that empowers work by-the-book, prevents shortcuts and includes specific checklists embedded in every task

Automatic generation of reports in real-time, eliminating the need to manually create reports after work is completed.

Reduces the non-utilization of often expensive tools by ensuring immediate awareness of availability for re-assignment, as well as better utilization of NDE teams and tools.

Real-time access of all relevant and most up-to-date documents and drawings to every user on a mobile device.

Learn more about what MobideoSTO can do for your STO.

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