VoiceVision® is a service that evaluates Interactive Voice Response, Voice and Data Networks, and Contact Centers. The results of this evaluation are especially suited for businesses operating in FDA-regulated environments. Our team has worked with systems subject to 21 CFR Part 11 regulations for nearly a decade. Given the rigors with which computer and telecommunications systems must operate in this environment, the VoiceVision® service specifically addresses the need for processes that comply with FDA regulations and guidelines. Our target market focus includes companies working in the following industries:
Pharmaceutical and Biotechnology
Pharma and biotech companies use IVR systems (IVRS), contact centers, and computer telephony to automate a host of business processes.
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.
Areas of application include but are not limited to:
REMS process automation for ensuring patient safety
Sponsor-managed clinical trials
Managed drug distribution
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.
Clinical Research Organizations
IVR systems (IVRS) and other Interactive Response Technologies (IRT) are increasingly used in clinical trials to enhance process efficiency, consistency, and patient safety. The benefits range from reducing manual procedures whereby risk is reduced to lowering the material and labor cost of conducting a trial.
Sponsors and CROs have turned to IVRS to perform or enable functions such as:
Randomization in blind studies
Patient Reported Outcomes (ePRO)
Electronic Data Capture (EDC)
Distribution/Inventory Management/Drug Pooling
Dispense to participants
Implementing an IVRS or IWRS for these purposes requires adherence to GxP guidelines for documentation, development, qualification and validation. This rigorous approach is intended to ensure the integrity of study data and therefore of the trial itself.
A VoiceVision® Evaluation will give you a clear understanding of how well your systems have been engineered and maintained in light of GxP regulations. Our 14 Point Diagnostic will look at areas important to you such as:
Design (protocol, user requirements, randomization specifications, functional and configuration)
Validation (traceability matrix, functional test documentation, OQ, PQ)
Change Control and Risk Assessment process
Scalability of IVRS application and infrastructure
Whether you are a sponsor or a CRO, we can help you gain piece of mind or identify areas of improvement so you can manage your trials efficiently and effectively while lowering risk. The use of IVRS technology is steadily gaining widespread acceptance in clinical research. Smart investment in your IVRS and telco infrastructure will prepare you to scale for future studies and protocols.
If you support a telephony environment in a regulated industry, you know that maintenance and upgrades require careful planning and execution. You have to document, validate and apply change control processes while satisfying business customers' need for new features to maintain your company's competitive edge. Because voice applications and contact center operations require extensive integration of complex systems, balancing these competing goals can be challenging.
Our VoiceVision® 14 point diagnostic evaluation helps you make sense of where you stand. We look at all areas that are important in any regulated industry, such as:
Quality of documentation
Business continuity planning
Evidence of appropriate testing and validation
Adequate work practices and standard operating procedures (SOPs) for ongoing support
Good documentation is the foundation on which highly reliable and useable systems are built. The foundation of good documentation is carefully maintained work practices, SOPs, requirements, design, testing, and configuration documents. Understanding how your systems are used and if the capacity you've provisioned is appropriate can help you save money and time.
This goes a long way in enhancing internal and external customer satisfaction. We've spent years helping clients who operate under some of the most rigorous sets of regulations. Let our experience help ensure your systems compliance.
Even if your voice-based systems do not operate in a heavily regulated environment, you still have challenges that are common to all organizations that seek to leverage technology to streamline business processes. A call center evaluation is recommended periodically to evaluate performance over time.
If you're making changes to your system over time, you need to reevaluate and ensure you're not making the system worse! The simple logic behind VoiceVision is that the best practices used to ensure quality in regulated industries will produce benefits everywhere. Appropriately adapting such practices comes down to understanding underlying business and technical goals. A common sense approach for applying analysis with a focus on value will benefit your organization greatly and help you prepare for the future.
A VoiceVision® 14 point diagnostic assessment applies a targeted set of criteria to measure complex systems. We are able to tailor our analysis to best fit your needs while keeping universal principles in mind. In the real world, the most useful systems find a sweet spot that combines affordability and technical accomplishment.
This point seldom lies with the cheapest solution or the most technically advanced. We can help you set realistic goals to maintain in serving your customers needs. The recommendations we deliver will in many cases confirm some ideas you already have as well as provide new insights no matter how your IVR system and contact center are used.
Our comprehensive evaluation and report will give you specific performance data across the following business processes.