Information management
Our web-based solution allows for field execution, secure uploads and easy access to all of your critical information, by everyone on the project team.
What does it look like when your validation lifecycle goes from good to GREAT?
BioVoke eVLM improves quality throughout the validation lifecycle.
By dynamically building traceability through true data driven lifecycle workflows, BioVoke eVLM actively controls some of the most error prone processes in your validation and quality environments, including risk assessments, trace matrices, and testing deviations.
BioVoke effectively improves quality across your operation by Minimizing errors, deviations, and data and information loss.
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Simple operations
The system is data driven, keeping automatic and constant linkage from the process and product data, such as CQAs and CPPs, through to test case execution, making automatic trace matrix reports as simple as the click of a button.
Cost reduction
BioVoke eVLM was specifically designed to reduce cost across the project and product life cycles.
From multiple executors on the same protocol, to dynamically linked discrepancies/deviations on protocols, BioVoke eVLM was designed to drive down costs.
Streamlining project delivery and minimizing typical cost overrun factors are trademark BioVoke eVLM benefits.
Test cases
Test cases can be approved in the system and saved in the library, allowing use of pre-approved test cases for like-for like equipment across global sites.
Validation and product life cycle management
BioVoke is made up of eight modules, all seamlessly integrated with one another, all designed to manage different aspects of the validation and product life cycle, as well as support functions such as change management and documents management.
Specification change control
Our engineering specification engine is used to link components to pre-approved specifications. Change control across specification is now tightly controlled.
BioVoke facilitates the science-based and risk-based validation lifecycle approach of ASTM E-2500
The best of both worlds with SaaS or on-premise hosting
BioVoke supports both the ASTM E-2500 risk-based approach to validation as well as other validation models.
Massively scalable, BioVoke can be deployed at one site or at dozens of sites across the globe. Available as SaaS or on-premise hosting, BioVoke is designed to exceed industry standards for data integrity and cyber security.
Built-in workflows for deviation management and change management drive efficiency, enhance visibility and reduce errors.
Advanced reporting and project management tools provide the visibility needed for the team to make informed, timely decisions.
BioVoke is designed for validated use in the life sciences industry.
It is FDA compliant in support of 21CFR part 11 guidelines.
BioVoke recommends that implementation of BioVoke in cGMP environments be subject to validation requirements, with the extent of these requirements depending on intended use of the system.
Scalable whether you're a small emerging company or a Fortune 50 global enterprise
Created to close the gap between the process control strategy and the validation lifecycle.
Designed specifically to implement QBD strategies for design elements, risks, hazards, FMEA workflows, and all inputs into the process control strategy.
BioVoke is in the Cloud
Paper becomes a thing of the past. Efficiency becomes standard. GMP compliance is easy.
- How much of your server storage does it require?
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None
All data is stored in BioVoke servers hosted by AWS.
- How much data can it manage?
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No Limit
BioVoke data storage with AWS is virtualized, so, as soon as we approach the virtual limit to the virtual disk, we can scale up additional storage automatically.
- Backups are managed in a multi-tiered fashion
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Automatically
BioVoke is hosted on Amazon Web Services (AWS), which provides robust replication and recovery service.