Pharmaceutical and Biotechnology

Pharmaceutical and Biotechnology

Pharma and biotech companies use IVR systems (IVRS), contact centers, and computer telephony to automate a host of business processes.  Areas of application include but are not limited to:

 

  • REMS process automation for ensuring patient safety
  • Therapy compliance
  • Sponsor-managed clinical trials
  • Post-marketing surveillance
  • Managed drug distribution

The promise of technology is lowering risk by achieving consistent, repeatable results.  Achieving this promise requires a rigorous set of practices to document, build and maintain information systems.  A VoiceVision® evaluation will give you a clear understanding of how well your systems have been engineered and maintained in light of GxP, FDA 21 CFR Part 11, and HIPAA regulations.  Our experience and knowledge of the end-to-end software and systems development lifecycles (SDLC) give us expertise to help you identify areas of meaningful improvement.  If your IVRS and contact center are used to process patient, prescriber or investigator communication and data, our 14 point diagnostic can help you ascertain:

  • Areas where your documentation may be insufficient to accurately represent your system for audits
  • Weaknesses in your business technology continuity plan
  • Determining if your systems have been adequately tested let alone validated to ensure desired functionality

Our evaluation report can help you construct a roadmap to keep your system compliant, technically up-to-date, and ready for future growth and change.  Recent events suggest that the FDA will be ever more stringent in the requirements it imposes on biotech and pharma companies in managing patient risk.  Chances are your telephony information systems are at the heart of the processes needed to comply.  We can help.

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