Proven for GMP and non-GMP Projects

BioVoke has been fully tested, both in our labs and in the field, and has been proven to meet all requisite regulations concerning the entire project cycle for GMP and non-GMP manufacturing facilities. It’s simple to use, highly reliable in service, and powerfully customizable to suit any unique requirements.

Clients need to demonstrate that any IT application meets user requirements when used with client SOPs, trained personnel, and ancillary input/output systems. Test packages are available for a nominal fee to support client validation requirements.

These packages include:

  • Records of our in-house testing
  • Electronic records/electronic signatures compliance report
  • Template PQ protocol for client to customize based on its user requirements and SOPs

Commissioning Agents, Inc. can customize the PQ, develop SOPs, train personnel, and otherwise assist in a full validation to customer user requirements. If the client chooses to customize BioVoke, such customizations would require testing against user requirements and software configuration challenges.

BioVoke can be deployed as COTS software or reconfigured to meet a regulated company’s needs. CAI’s recommendation to regulated customers for a COTS deployment would be to classify the software as a GAMP V Category 3. However, the regulated firm ultimately must assign GAMP Categories.

Security

Through Amazon Web Services we provide clients with world-class, highly secure data centers that utilize state-of-the art electronic surveillance and multi-factor access control systems. The cloud infrastructure has been designed and managed in alignment with current regulations, standards, and best-practices.

For more information on Amazon Web Services visit https://aws.amazon.com/whitepapers/.