We provide regulatory-compliant solutions that fill the gaps in manufacturing execution, including an EBR (Electronic Batch Record) system used by our customers to obtain FDA approval of their production processes. This automation 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:
- Identification and prevention errors
- Improved workforce competency and increased productivity
- Full compliance with the strictest regulations, GMP best practices and FDA demands for work by checklists
- Elimination of delays caused by safety and compliance activities
- Better quality and safety
- Better business results in all manufacturing processes
Are your manager’s decisions based on real-time data from the field?
- Real-time visibility and situational awareness
- Real-time dashboards and data analytics to support manager decision-making
Are your workers working according to FDA regulations and checklists, your processes and best practices?
- Presentation of tasks and relevant instructions to workers, in checklist format, on any mobile device
- Real-time monitoring of worker performance and execution
Is work being performed efficiently and at a suitable level of quality?
- Validation of adherence to required task execution plan
- Resolution of events through the rapid deployment of corrective actions
Is work aligned with the relevant EHS guidelines and requirements?
- Paper-free environment that empowers work by-the-book, prevents shortcuts and includes specific checklists embedded in every task
- Real-time visibility to managers, ensuring proactive, fast response and easier mitigation of EHS risks
Facing problems tracking contractor performance and managing contractor budgets and schedules?
- Step-by-step capture of task execution and data input, including timestamps, location tags and signatures
- Optimized field execution and increased productivity through real-time events and work plans, modifiable priorities and efficient resource allocation
Forced to work with multiple systems to support different tasks and use cases?
- One robust platform with multiple use cases
- Seamless integration with existing IT/OT systems, ensuring use of existing data, use cases and point solutions
Access to Data
Is your unique knowhow and data stored in diverse, often unstructured and forgotten systems?
- Seamless and safe ingestion/digitalization of knowhow and processes from documents, forms and IT/OT systems – a paperless world where no documents have to be printed
- An elastic data model that precisely mirrors business processes and operational knowhow in a cyber-secure, customized data model