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

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.