Pharma Intelligence (PI Solutions)
Software designed by Life Science development people for Life Science development.
Our cloud-based and Artificial Intelligence powered pharma intelligence platform provides insights and strategic guidance to life science companies looking to navigate the complex landscape of the industry with efficiency and demonstrative compliance. By leveraging advanced data analytics and industry expertise, we provide our clients with the information and tools they need to make informed decisions and stay ahead of the competition. Our differentiators versus existing software are outlined below.
- Our products are Annex 11 and CFR Part 11 compliant and designed to follow life science life cycle management workflows and processes.
- Monitoring and compliance are automated and mapped to audit ready workflows and processes.
- Pre-populated actions enable intuitive adoption and greater efficiencies and controls.
- Resource allocation and forecasting is optimized through predefined change controls on actions/timelines so assignment of tasks can be according to individual employee available capacity and utilization targets.
- Employee training is automatically tracked to enable mapping of assigned tasks to individual capabilities.
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PMS ++
- Documentation filing and management (e.g., Trial Master Files) are integrated into the Project
Management System - Creation, review, and approval of documentations are embedded into the PMS.
- Protocol design is integrated into the PMS.
- Critical path optimization through automation of task completion both sequential and parallel
- Documentation can be collected through scanning by mobile phone in addition to scanners.
- Budgets are embedded in PMS to enable controls versus actuals with reporting out on realization
versus target. - Dashboards at multiple levels (activity, project, department) to enable visibility on performance to all
stakeholders internal and external. - Design is intuitive even for new staff in terms of workflow, tracking of changes, and impact.
- Substantial reduction in the use of emails and ease of budget reconciliation
QMS ++
- Effectiveness checks are automated within the system to track and assess whether CAPAs were
effective; historical analysis and recommendations based on specific deviations.
PV ++
- US/EU regulatory interface developed with AI algorithm with data from the public domain, thereby
automating and substantially reducing the literature searching and inputting time. - This enables employees to focus on create/review/approve functions.
RA ++
- FDA/EMA/MHRA documentation and data flow aligns with development activities.
- Standard sections are auto filled and loaded from the PMS; variable sections can be programmed by
the user. - The dossier compilation is automated to enable expedient publication.