BioVoke is a cloud-based project management software that allows users to centralize, track, and manage critical information across projects from product definition through GMP operations. It has six modules for product and process knowledge, requirements and design, verification planning, paperless verification development and execution, issues and change management, and document management. BioVoke provides real-time collaboration, efficient information management, and electronic testing capabilities to help teams deliver high-quality, compliant manufacturing facilities on schedule and under budget.

1. BioVoke Version 2.0 www.biovoke.com
Deliver projects faster
- at lower cost
Manage GMP information
- in one centralized location
Standardize project delivery
- across worldwide locations
From product and process definition to
full-scale GMP operations, BioVoke™ is
your solution to the triple demands of
cost reduction, schedule reduction,
and the mandate to deliver quality and
compliant manufacturing facilities.
BioVoke™ provides you with efficient
information management and
electronic testing capabilities that
allow your teams to effectively execute
on their mission to deliver highly
reliable, high performance, qualified
facilities and processes.
Process control strategy, quality risk controls,
user requirements, test plans, critical design
aspects, commissioning, FAT, SAT, verification,
protocols, punch lists, issues, TOPs, SOPs,
project changes, deviations, meeting minutes,
scope definition, key decisions, action items…
Can we centralize, track and manage all of the
above with a single solution that links critical
information across a project? BioVoke™ can!
Our web-based solution allows for field
execution, secure uploads and easy access to
all of this information.
What if project teams across the globe had
access to a cloud-based solution that
allowed for real-time collaboration and
provided an efficient process to deliver
GMP manufacturing capacity? BioVoke™
can do this while supporting traditional
C&Q approaches or the ASTM E2500
approach to meet quality risk management
expectations based on product and process
knowledge. BioVoke™ can be easily
tailored to align with your project delivery
process, and provide you with a preferred
mix of flexibility, control and security.
BioVoke™ – Unique Application, Unique Capabilities

2. BioVoke Version 2.0 www.biovoke.com
BioVoke™ – Module Descriptions
BioVoke™
Overview
BioVoke™ is comprised of six (6) modules that can work independently or as an integrated suite. Current suite includes:
 Product and process knowledge
 Requirements and design
 Verification (test) planning
 Verification (paperless) development and execution
 Issues and change management
 Document management
The Admin Tools, Master Data and Project Management modules are included with any of the above modules.
Product and
Process
Knowledge
Capture product attributes, process steps and quality attributes; and link Critical Quality Attributes (CQAs) to Critical
Process Parameters (CPPs), to produce a complete, well-thought out set of process requirements. Then 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 air-tight testing and qualification with our Requirements and Design module. Requirements and design elements
can be individually developed or imported, reviewed and approved. You can also add attachments to support your
requirements and design, reference other documents, link requirements to systems, or even create a collaboration group
and tackle requirements and design as a team. The design review aspect is used to verify that requirements have been
satisfied by design elements and can be collaboratively reviewed and approved. BioVoke™ automatically links
requirements to design and testing and builds traceability matrices to document that all requirements have been met.
Verification
Planning
Support all of your project planning activities using the Verification Planning module. This module accommodates high-
level project planning to document which test phases (e.g., RV, FAT, IV, OQ, etc.) are applicable for a 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, and the added security and
speed of electronic review, approval and execution. Developing test protocols using the document library and using
electronic routing, approval and execution reduces schedule time and eliminates redundancy, lost documents, GDP issues
and formatting issues. Tests can be executed using workstations or tablets. Take pictures for tests steps on the go. 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 eliminate paper trails 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, including pull down menus, 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, meetings, action items and decisions more efficiently using this module. Develop
meeting agendas, invite individuals or groups, assign and track action items 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.