Our Commitment To You

We commit to delivering the following Service Level to you, included in the price of license fees for BioVoke:

  • System Availability: 99% (1% reserved for system maintenance).
  • Backup Services: Nightly Full Backup, 4-hour differential. All backups stored on secured SAN and mirrored to an independent archive. Archives are compressed and encrypted.
  • Disaster Recovery: The server is mirrored allowing for complete failure of one server with no loss of data and minimal (if any) service interruption.
  • Fully staffed support team standing by.
  • The SLA offered by Amazon Web Services can be found here.

Licensing

BioVoke can be licensed either by project or by subscription. The project pricing allows unlimited users to access all the features of BioVoke. Subscription pricing allows access to a limited range of features for a much lower yearly fee per user.

Infrastructure

Since BioVoke is hosted in the cloud, there are no infrastructure costs beyond what is already incurred by maintaining a LAN and Internet connections.

Maintenance

After software solution delivery and customer acceptance, the operation and maintenance phase of the software development life cycle (SDLC) begins. At this time, processes must be in place to ensure the system is maintained and controlled in such a way to remain fit for its intended uses. The processes required may include:

Included in Service Level Agreement:

  • Performance monitoring
  • Support and maintenance activities
  • Backup and recovery
  • Business continuity/disaster recovery
  • Incident management
  • Records management and archival

Outside of Service Level Agreement:

  • Corrective and Preventive Actions (CAPA)
  • Change management
  • Periodic review/internal audits
  • Security management/administration and maintenance of access control lists
  • User and maintainer training
  • Revalidation

Standard subscription fees cover items included in the Service Level Agreement. Items outside the Service Level Agreement may be purchased for an additional cost.

Validation

BioVoke is used for management of requirements, specifications, risk assessments, and commissioning and validation test cases, all of which are quality-managed, GMP electronic records. Additionally, the system manages review and approval signatures, as well as evidence of executed test cases, in the form of electronic signatures for these records.

Regulated customers using BioVoke to manage predicate rule records are required to validate the system per its intended use in accordance with their quality system.

A typical set of validation deliverables includes:

  • Validation Project Plan
  • User Requirements Specification (URS)
  • Configuration Specifications for each database instance
  • Installation Qualification (IQ) for each database instance
  • Functional Specifications (FS) in the form of Use Cases for each solution
  • Operational Qualification (OQ) for each solution
  • Traceability Matrix
  • Qualification Summary Report

Procedures

Standard Operating Procedures (SOPs) are needed for successful operation and maintenance of BioVoke solutions and data after deployment. The following is a list of procedures that are typically needed for a BioVoke implementation:

  • Management of Antivirus Software
  • Backup and Restoration of Data
  • Data Security and Security Monitoring
  • BioVoke Database Backup, Restoration, and Archiving
  • BioVoke Business Continuity Plan
  • Use and Operation of BioVoke
  • Software Change Control and Configuration Management
  • Computer System Access Authorization and Control
  • Employee Training Program
  • Computerized System Maintenance and Use Logs
  • Service Requests and Problem Reporting
  • Periodic Review of Controlled Documents

CAI can manage or support development of any or all of the procedures listed above for a negotiated cost, if desired.

Training

CAI can conduct remote or on-site classroom training depending on which implementation plan is purchased.  The cost will vary depending on the implementation plan and the number of modules.