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.
Improve Quality
End-to-end traceability in real time
BioVoke’s data-driven design dynamically builds traceability links through the validation lifecycle, giving you real-time visibility and traceability reports on-demand.
Reduce cost
Reduce cost of quality
Errors causing rework are a leading cause of cost overrun. BioVoke helps your team get it right the first time, every time.
Reduce cost of capital projects
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.
Manage Risk
Control process and product risk
Built-in workflows document product and process information, conduct risk assessments, develop control strategies and document approved design specifications.
Control project and capital risk
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.
Projected Savings
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 |
Case Study:
BioVoke eVLM Vs. Paper Protocols
$300 Million Project
The problem
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.
The solution
Employed Biovoke Verification Development and Execution Module along with the Issues and Change Management module.
The results
BioVoke demonstrated a 42% savings in end-to-end development and execution when compared to traditional paper protocols.
Case Study:
Biovoke Change Management & Automation Configuration
2.5 year / $2+ Billion Project
The problem
Track changes to equipment design and automation system configuration during construction and commissioning.
The solution
Employed BioVoke Issues and Change Management capability of BioVoke Core.
The results
Tracked and resolved over 2000 engineering equipment and automation changes with $800k savings in process efficiencies.