Reduce Deviations
BioVoke's data-driven approach helps life science firms enhance quality by design and reduce deviations that result in lost time and lost product.
BioVoke's data-driven approach helps life science firms enhance quality by design and reduce deviations that result in lost time and lost product.
BioVoke’s data-driven design dynamically builds traceability links through the validation lifecycle, giving you real-time visibility and traceability reports on-demand.
Errors causing rework are a leading cause of cost overrun. BioVoke helps your team get it right the first time, every time.
BioVoke has built-in scheduling tools to link validation activities to project milestones, ensuring all actions are complete and deviations are closed out in a timely manner.
Built-in workflows document product and process information, conduct risk assessments, develop control strategies and document approved design specifications.
Robust project management capabilities help the project team plan and execute the validation project. KPIs give visibility to help project management ensure milestones are met.
The entire BioVoke suite provides significant cost and schedule savings, while keeping all of your information current and secure. Estimated savings are anywhere from 20 – 40% for project delivery, based on the efficiency gains for the activities listed below.
Estimated Savings % of Activity Budget | Potential Savings Area |
---|---|
5–10% | User Requirement Development |
5–10% | Design Reviews |
10–30% | Planning |
20–40% | Project Management |
20–50% | Protocol Development |
25–40% | Document Review/Approval |
25–50% | Change Management |
40–65% | Protocol Execution |
50–65% | Issue/Discrepancy Management |
90–100% | Traceability Report Development |
$300 Million Project
Conduct a side-by-side comparison for the development, pre-execution review, execution, post-execution review and deviation tracking for an IOQ protocol on a complex piece of equipment.
Employed Biovoke Verification Development and Execution Module along with the Issues and Change Management module.
BioVoke demonstrated a 42% savings in end-to-end development and execution when compared to traditional paper protocols.
2.5 year / $2+ Billion Project
Track changes to equipment design and automation system configuration during construction and commissioning.
Employed BioVoke Issues and Change Management capability of BioVoke Core.
Tracked and resolved over 2000 engineering equipment and automation changes with $800k savings in process efficiencies.