The regular calibration of sensitive medical equipment test instrumentation such as temperature sensors, pressure transducers and weighing instruments is mandated by the U.S. Food and Drug Administration (FDA). Precise and repeatable measurements are crucial for test equipment being used in the medical equipment given the increased risk associated with non-compliance for medical device manufacturers.
Mitigating risk for these manufacturers hinges on five key areas of medical equipment calibration management that must be attended to in order to maintain regulatory compliance:
- Documentation
- Planning and Decision Making
- Organization
- Execution
- Analytics and Reporting
With a high quality, integrated asset management application such as CalWeb from Tektronix, all aspects of running a calibration program are improved.
Users are provided with a centralized, accurate way to analyze calibration records and identify historical trends.
All instrument and calibration data is stored electronically, allowing for analysis, optimization of calibration frequency and effortless reporting. Certificates and labels can easily be printed and distributed. Barcodes can be generated for seamless communication and syncing of data with smart calibrators.
Customers who have already deployed a CMMS can easily integrate it with web-based applications using bulk upload features; built-in document control features ensure compliance with FDA and ISO regulations.
CalWeb Covers the Bases
CalWeb benefits medical device companies in each of the five major areas above that are essential in managing a calibration program within a highly regulated environment.
- Documentation. CalWeb is compliant with ISO and FDA regulations and features secure, sophisticated document and change controls including document lifecycle management, audit trail history, cross-linking and a centralized repository.
Why it matters? These features increase productivity while eliminating the issues for which regulated companies are most often being cited. Document retrieval and reporting is virtually effortless when compared to traditional calibration record keeping.
- Planning and Decision Making. All Tektronix and internally managed asset information, including instrument locations, calibration intervals and tolerance information can be defined and managed within the CalWeb application.
Why it matters? Administrative costs are reduced when a system becomes paperless. Automated calibration results and tolerance history can easily be analyzed and may justify reduced calibration frequency for equipment that exceeds required process tolerances.
- Organization. CalWeb provides a seamless way to streamline standard operating procedures. Permission levels can be assigned which will designate access based on the level of training each user has completed. Advanced analytics and reporting features allow for escalation of uncompleted tasks to the appropriate levels.
Why it matters? Streamlined operating procedures improve company-wide efficiencies and result in reduced training time and costs. Calibration forms and assignment status are tracked electronically and provide automated version control.
- Execution. Using CalWeb, calibration tasks are easily tracked and maintained throughout the organization. Automatic alerts can be set so that appropriate personnel are notified when calibrations are due. Service orders can be generated and tracked right from the user’s console. Customer recalls for calibration and work-in-progress status updates can all be managed within CalWeb.
Why it matters? Automated reminders, calibration cycle management and supply chain procurement features allow CalWeb customers to provide seamless and consistent service to their clients. The ability to view service status and inventory updates in real time leads to increased plant efficiencies and more proactive risk management.
- Analysis. Inaccurate tracking and a lack of effective analysis can put an entire organization at risk. CalWeb from Tektronix offers a central and secure document repository, real time email notifications and advanced system reporting that provides for company-wide visibility regardless of physical location..
Why it matters? In the case of an audit, CalWeb can facilitate both the preparation and the audit itself. Being able to simply and quickly validate organization-wide process controls reduces regulatory, scientific and business risks.
Tektronix recognizes that medical device companies are making a real difference in people's lives. While compromised production quality in any industry can mean financial losses, we understand that in the healthcare sector it can even mean loss of life. With over 70 years in the test and measurement industry, no one knows calibration better than we do. It's your job to make life easier for others. It's ours to provide world-class resources that make life easier for you.
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