How a 72-strong calibration laboratory, accredited by A2LA, replaced manual monitoring, eliminated audit-related risks and achieved a volume of over 60,000 calibrations a year thanks to JRI MySirius.
| Over 60,000 | 72 | 1 week |
| Calibrations per year | Calibration Division Staff |
Standard turnaround time |
NovaStar Solutions is an A2LA-accredited calibration service provider that operates one of the most diverse and largest calibration divisions in the Midwest.
With 72 professionals specialising in calibration and expert teams covering a range of disciplines, NovaStar supports clients in the automotive, aerospace, medical devices, pharmaceutical and household appliance manufacturing sectors sectors where measurement integrity is an absolute requirement.
The company carries out more than 60,000 calibrations a year and guarantees a standard turnaround time of one week a competitive commitment that minimises downtime for customers and eliminates the costs associated with replacement equipment. NovaStar also offers a free collection and delivery service, a competitive advantage that makes life easier for customers responsible for managing the logistics of calibrations across multiple product ranges.
Calibration laboratories are particularly sensitive to environmental variations. Temperature and humidity are not merely background conditions: they are active variables that directly affect the accuracy of measurements.
Metal components expand when heated, which distorts the results of dimensional checks. Low humidity generates static electricity, which damages sensitive electronic components. High humidity accelerates corrosion.
Any deviation from the specified ranges during a calibration procedure may invalidate the results and lead to further costly calibrations.
Before adopting JRI MySirius, NovaStar relied on manual processes to monitor and record laboratory conditions.
Candace Bryant, Quality Manager at NovaStar, described the operational reality in no uncertain terms: manual humidity monitoring posed considerable challenges in terms of data collection and trend analysis. Staff spent a great deal of time entering data, reconciling records and monitoring alerts – tasks that increased the administrative burden without improving measurement results.
“Manual humidity control processes present challenges when it comes to compiling data and analysing trends.”
The issue of compliance has further exacerbated the problem. NovaStar operates in accordance with the requirements of 21 CFR Part 11, the FDA’s regulatory framework governing electronic records and audit trails for regulated sectors.
To demonstrate to auditors that environmental monitoring was continuous and time-stamped with no gaps, no manual data entry and no reconstructions – a level of data integrity was required that manual data entry simply could not guarantee on a large scale.
NovaStar has implemented JRI MySirius as a remote monitoring platform across all its calibration laboratories. The system provides continuous, automated monitoring of temperature and humidity conditions, with configurable alert thresholds directly linked to the performance of the heating, ventilation and air-conditioning (HVAC) systems and humidity control systems.
Guy Howe, Director of Calibration Services at NovaStar, highlighted the fundamental operational value of this system: alerts are configured to flag any deviations in temperature and humidity, enabling immediate corrective action to be taken as soon as specifications are exceeded.
Rather than discovering that parameters have drifted during a retrospective review of the data, the laboratory management receives real-time notifications accompanied by timestamps and details of the deviations all of which are precise details that are essential for root cause analysis.
“JRI’s equipment enables Novastar to automate its processes, thereby reducing manual data entry and minimising human error during calibrations.”
NovaStar has opted for an on-premises server deployment rather than a cloud-based configuration a deliberate choice that reflects the company’s data security policy and its business continuity requirements.
On-premises deployment means that the monitoring system operates independently of any third-party infrastructure, thanks to redundant data backups that ensure NovaStar can maintain its calibration operations and protect its customers’ data even in the event of external network disruptions.
Integration with NovaStar’s existing laboratory management system has further enhanced the added value.
Technicians no longer need to switch between systems or carry out manual data transfers. JRI MySirius integrates directly with operational processes, allowing staff to focus on carrying out calibrations rather than on entering environmental data. This level of data integrity is simply impossible to guarantee on a large scale with manual data entry.
The impact of JRI MySirius at NovaStar centres on three key areas:
In terms of compliance, the system has removed any uncertainty regarding compliance with 21 CFR Part 11.
Thanks to automated audit trails, time-stamped environmental records and configurable alert thresholds, NovaStar has a verifiable and defensible data chain that can withstand scrutiny by auditors without the need for manual reconstruction.
Bryant emphasised that JRI’s compliance with the provisions of Title 21 of the CFR, Part 11, helped to streamline the review process by eliminating approximations and replacing interpretation-related risks with verifiable documentation.
In terms of efficiency, Howe has directly quantified this development: the JRI system has reduced the costs associated with monitoring temperature and humidity, whilst offering features that surpass those of previous solutions.
By automating the monitoring of facility status and the management of alerts, NovaStar has enabled its staff to save time that was previously spent on manual inspection rounds and data compilation; these resources have thus been redirected towards increasing throughput and improving customer service.
“The JRI system reduces the administrative burden on staff, allowing them to focus on other key aspects of their work.”
When it comes to customer trust, the operational benefits lie upstream of what customers perceive but are felt directly.
NovaStar’s commitment to a one-week turnaround time is only possible if environmental conditions remain under control and if calibrations are not compromised by undetected variations within the laboratory.
When conditions change, JRI MySirius immediately flags the event, providing sufficient contextual data to identify the root cause before any recalibrations exacerbate the delay.
Eric Hanaka, sales director at NovaStar, where he has worked for 26 years, highlighted the benefits of JRI, particularly for clients operating in regulated environments: for organisations subject to strict regulatory requirements, JRI’s solutions meet the environmental monitoring requirements imposed by compliance frameworks, whilst providing a data trail that attests to the integrity of the data an integrity that manual recording simply could not guarantee on a large scale.
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NovaStar’s decision to opt for JRI MySirius reflects the platform’s positioning as a system specifically designed for compliance monitoring, rather than as a versatile IoT tool suitable for regulated use.
Key features that influenced this decision include: flexible deployment options (cloud-based and on-premises), real-time alerts accompanied by time-stamped deviation data for root cause analysis, compliance with 21 CFR Part 11 and documentation relating to regulatory compliance, as well as seamless integration with existing laboratory information management systems.
For calibration operations, pharmaceutical manufacturers, medical device laboratories and any regulated environment where ambient conditions form part of the compliance dossier, JRI MySirius provides monitoring that serves as evidence not just data.
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