The Continued Process Verification platform for pharma manufacturing
Stage Three is the intuitive platform providing the essential tools your organization needs to ensure production processes remain in a state of control throughout their lifespan.
From traditional process verification techniques to continuous monitoring of vast amounts of data
Organizations have access to an unprecedented amount of (often real-time) data from a broad array of integrated systems and standalone equipment. And yet, many of them are still relying on plant audits and product sampling as the primary source for feeding their Continued Process Verification programs. These techniques provide process snapshots at a particular time and don't allow real-time tracking of your Critical Performance Parameters and Critical Quality Attributes.
Stage Three is the data acquisition, visualization, and analytics platform purpose-built to address these challenges.
Statistical Process Control
Get complete visibility and control over your production processes
Connect your systems (ERP, MES, LIMS) and standalone equipment for automatic data acquisition.
Browse single and multiple target parameter data in various formats, including table, control, and process capability charts.
Access the comprehensive regression statistics and capability indices when you need more details.
Proactive Monitoring
Identify potential issues before they create major challenges
Receive notifications (e-mail, in-app, web push) about trending violations as soon as they occur.
Subscribe to the target parameters of interest for quick access and notification.
Record the findings of any rule violation investigations to keep them in context.
(D) You have not conducted Stage III Continuous Process Verification (CPV) to ensure that commercial products remain in a state of control. The requirement to implement continuous process verification was introduced in SOP No. [ ]. You have only conducted Stage III Continuous Process Verification on [(b)(4) ]. The rationale for selecting this product for CPV is not documented and you do not have any documented plans to conduct the CPV activities on other products commercially distributed in the U.S. market.
Early Adopter Program
Stage Three encompasses all the learnings and knowledge we have accumulated in running a CPV program for over eight years. While the platform works very well for our specific use cases, we want to take it to the next level and open it to other organizations that can benefit from our extensive experience.
If you are a small to mid-sized European manufacturer, the Early Adopter Program is your opportunity to gain a new perspective on your processes before your competitors do.
Not only will your organization get access to the Stage Three platform at a reduced price until it becomes commercially available, but you will also gain direct access to our development team to adapt Stage Three to your specific needs.
In exchange, we ask your team to provide periodic feedback to help shape the final platform.