BioVoke Description 

BioVoke is a suite of integrated applications that is specifically built to enhance the quality, speed and efficiency of project delivery. BioVoke has leveraged two decades of project experience to design and implement a superior system.

Starting from the basis of product and process knowledge, BioVoke allows the project team to work through all phases of a project including risk assessments, requirements definition, commissioning and qualification planning, electronic protocol development and execution, document management, and discrepancy management.

Product and Process Knowledge

Capture product attributes, process steps and quality attributes, then link Critical Quality Attributes (CQAs) to Critical Process Parameters (CPPs), to produce a complete, well-thought-out set of process requirements. Identify process hazards and risk factors, determine detection methods, and develop manufacturing process control strategies. BioVoke maintains these links in an easy-to-use interface that allows users to perform robust design reviews that adequately mitigate risk factors and risk-based testing that ensures requirements are met.

Requirements and Design

Ensure accurate testing and qualification with our Requirements and Design module. Requirements and design elements can be individually developed or imported, reviewed, and approved. Add attachments to support your requirements and design, reference other documents, link requirements to systems, and create a collaboration group to tackle requirements and design as a team. The design review aspect verifies that requirements have been satisfied, and can be collaboratively reviewed and approved. BioVoke™ automatically links requirements to design and testing, then builds traceability matrices to document how all requirements have been met.

Verification Planning

Support all of your project planning activities using the Verification Planning module. This module provides high-level project planning to document which test phases (e.g., RV, FAT, IV, OQ, etc.) are applicable for any given system or component, as well as more detailed planning to assign actual testing elements or test cases.

Verification Development and Execution

Create complete test documents with all of the functionality of a paper protocol or test case, with the added security and speed of electronic review, approval and execution. Increase your team’s efficiency and eliminate redundancy, lost documents, GDP and formatting issues. Develop test protocols using the document library and electronic routing, review, and approval.  Tests can be executed using workstations or mobile devices. Take pictures on the go of active tests. Add attachments, generate discrepancies, build test cases from previous electronic protocols, and collaborate with other users across the globe in real-time.

Issues and Change Management

Use the Issues and Change Management module to manage issues and changes independently or in conjunction with the Verification Development and Execution module. Get full visibility on issues, discrepancies, non-conformances, or project changes from inception to closure. Itemized cost analysis and schedule impact are also included. Assign actions to users to ensure issues get resolved, track those actions, and get email notifications when they get completed. Electronic signatures can be used to review and approve issue activities.

Document Management

Manage GMP documentation with confidence and efficiency using BioVoke. Draft, review, and approve all documentation in one system using easily configurable review and approval workflows. Built-in version control and comment threads allow for collaborative efforts to stay with the document when accessed from any BioVoke module.

Track document and user activity in real-time and ensure traceability with audit trail functionality. Easily import, upload, download, and share documents. Use metadata to search the document repository with ease. Use document subscriptions to receive email notifications and stay up-to-date on revisions. BioVoke ensures business continuity by securely storing your electronic documents on an off-site server with daily backups.

Admin Tools

Manage all information pertaining to project personnel, including the creation and management of groups and teams, in one convenient location using the Admin Tools module.

Master Data

Manage and track all of your data, via custom pull-down menus that provide asset information, location information, and project information, in one convenient location. This central hub module feeds information to all other modules, ensuring that your data is always current. It allows tracking of all information pertaining to your assets, including equipment, instruments, skids, operational spare parts, consumables, and startup spares. In addition, instrument and equipment data can be seamlessly exported to your company’s CMMS.

Project Management

Manage high-level project information and document meetings, action items and decisions with this module. Develop meeting agendas, invite individuals or groups, and log decisions all in one location. Provide access to upcoming agendas, meeting minutes, action items and decisions, each of which can be searched for based on subject, date, people or any of our other searchable fields.