CTS leak instrument eases regulatory compliance for medical device manufacturers
May, 14, 2019 – Harrison, Ohio – Cincinnati Test Systems (www.cincinnati-test.com), the experts in leak detection equipment, is helping medical device manufacturers comply with 21 CFR Part 11 and EU Annex 11 requirements for storing and protecting electronic records with the latest release of Sentinel Blackbelt Pro.
Blackbelt Pro is CTS’s next generation of multi-channel test instrumentation that provides pressure and vacuum leak, flow and ramping testing for medical device manufacturers. It can manage and execute testing of up to four parts (synchronous or asynchronous), all under the control of one Blackbelt Pro instrument.
The U.S. Food and Drug Administration’s 21 CFR Part 11 and European Medicine Agency's Annex 11 are guidelines for storing and protecting electronic records and applying electronic signatures. These guidelines extend to the manufacturing, testing, packaging and distribution of medical devices, which are subject to stringent documentation and audit requirements. While 21 CFR Part 11 and EU Annex 11 have existed for more than 20 years, the rise of data-driven manufacturing and quality control processes typical of Industry 4.0 have heightened their importance.
Leak testing is a crucial quality control process in medical device manufacturing. As leak testing technology has evolved, leak test instruments have come to collect and manage larger and larger volumes of data. How this data is secured, accessed and manipulated falls under the scope of the 21 CFR Part 11 and EU Annex 11 guidelines.
The latest release of Sentinel Blackbelt Pro includes improvements and enhancements developed in consultation with medical device manufacturers to assist with 21 CFR Part 11 and EU Annex 11 compliance.
Blackbelt Pro features that support 21 CFR Part 11 and EU Annex 11 compliance
Unique User IDs
250 unique user profiles may be stored within the instrument. User authentication requires a unique password for each user. This limits access for specific functions to permitted users only. The administrator can also create unique user roles with security parameters defined for each user.
Audit / Activity Log
A non-editable Audit Log is available that outlines events (logins/executions/edits time and date stamped) performed by all users. Log entries are stored in onboard memory while the system stores all the activity with a built-in autosave function.
Instrument Edit Comments
This may be invoked to force users to enter reasons and comments when any changes are made to the instrument.
PDF Report Generation
All reports, such as Test Result Data, Program Configuration, Instrument Setup, Audit/Activity Log, may be exported as a non-editable .pdf document.
The administrator function of Blackbelt Pro allows the highest authorized user to assign and manage capabilities to other users in regard to:
- Password expiration days
- Max login attempts
- Inactivity timeout and expiration
- Customizable login banner messaging
To learn more about Blackbelt Pro and 21 CFR Part 11 and EU Annex 11 compliance, contact us.
Since 1981, Cincinnati Test Systems, Inc. (CTS) has delivered precision leak detection equipment, functional test systems and assembly verification testing to manufacturers. Its Sentinel, TracerMate and LPC product lines are used for pressure and vacuum decay leak testing, flow testing and tracer gas testing in the medical device, automotive, consumer products, off-highway, oil and gas, and energy sectors. CTS is part of the TASI Group of Companies’ Product Integrity organization, along with Sciemetric and CTS-Schreiner. The Product Integrity organization provides Industry 4.0 leak test, data management and analytics solutions that help manufacturers worldwide improve quality and productivity. CTS has sales and support offices in the U.S., Europe, China and Korea.
CTS and Sciemetric release QualityWorX for CTS instruments
Added data collection, analysis capabilities optimize test station performance
July 17, 2018 – Harrison Ohio and Ottawa Ontario – Cincinnati Test Systems (www.cincinnati-test.com) and Sciemetric Instruments (www.sciemetric.com) have brought the data management and analytics of Manufacturing 4.0 to leak and flow testing with the first of many innovations to come from their collaboration as part of the TASI Group of Companies.
To achieve Manufacturing 4.0, manufacturers need to make the most of their production line data, for higher first-time yields and faster resolution when quality issues arise. This is particularly true for leak testing. Practical and integrated tools are needed to make more effective use of data and ensure this crucial quality assurance process is reliable, repeatable and quick enough to keep pace with production. This is why CTS and Sciemetric have now made it possible to collect, store and analyze data from CTS instruments using QualityWorX.
The QualityWorX CTS DataHub is a turnkey platform for collecting and analyzing data from up to five CTS Sentinel instruments at a time, without requiring complex IT support to set up. It includes a host PC and Sciemetric Studio analytics software. Sciemetric Studio aggregates serialized leak test data for on-demand and in-depth analysis and visualization. Manufacturers can begin collecting and analyzing data within minutes.
For more extensive data collection requirements, the QualityWorX CTS Data Connector allows data from a CTS Sentinel instrument to be pushed to a QualityWorX database. This enables consolidation of production data from leak tests with other tests along the line, providing a centralized, accessible and traceable record of part data across assembly processes.
All the data can be analyzed using Sciemetric Studio software for continuous optimization of a test process, clear proof of compliance and quick response to issues that affect testing.
Unified under the TASI Group’s Product Integrity organization, CTS, Sciemetric and CTS-Schreiner together provide quality and productivity solutions to manufacturers worldwide.
“Together, we deliver the largest and most comprehensive leak test product portfolio in the industry, with the data analytics horsepower manufacturers need to compete,” said Kevin Hansell, President of CTS. “The QualityWorX CTS Data Connector and the QualityWorX CTS DataHub are great first examples of the complementary strengths of our two companies and how we can help manufacturers drive production quality and efficiency.”
In the months to come, CTS and Sciemetric will roll out additional data integration capabilities that will allow enterprise users to create truly connected factories.
“For years manufacturers have relied upon QualityWorX to improve quality, efficiency and yield across their production lines,” said Nathan Sheaff, President of Sciemetric. “With CTS, we have found a strong partner with which to deliver even greater value by connecting more data sources from across the plant floor. This is just the beginning as we build from leak test to any test.”
For more information, go to www.cincinnati-test.com or www.sciemetric.com.
Since 1981, Cincinnati Test Systems, Inc. (CTS) has delivered precision leak detection equipment, function test systems and assembly verification testing to manufacturers throughout the world. Its Sentinel, TracerMate and LPC product lines deliver pressure and vacuum decay leak testing, flow testing and tracer gas testing. CTS is known as the leak detection expert in automotive, consumer products, off-highway, medical devices, oil and gas and energy. Today, CTS is expanding its capabilities in data management and analytics to help manufacturers rise to the challenge of Manufacturing 4.0. CTS has sales and support offices in the U.S., Europe, China and Korea.
Sciemetric has partnered with manufacturers for over 25 years to solve their biggest productivity and quality issues, and optimize their production lines quickly, through in-process monitoring/testing and practical data analysis. It works in the global automotive, off-highway, medical and consumer electronics industries to help manufacturers bring Manufacturing 4.0 to their production line, from leak test to any test. The data management and manufacturing analytics of QualityWorX and Sciemetric Studio empower manufacturers to start using their data today for visibility and fast issue resolution. Sciemetric has sales and support offices in Canada, the U.S., the U.K., India and China.
Tim Cook visits Cincinnati Test Systems to discuss Leak Testing
Harrison, Ohio (The Equirer/Cara Owsley) – August 24, 2017 ─ Apple CEO Tim Cook was in Harrison Thursday visiting local manufacturer Cincinnati Test Systems, who developed a high-pressure testing instrument for Apple. (Read More)
Harrison, Ohio (WKRC) – August 24, 2017 - Tim Cook, CEO of Apple, visited Cincinnati Test Systems in Harrison on Thursday. CTS is a key Apple supplier.
Harrison, Ohio (USA Today by ) – August 29, 2017 ─ Tim Cook's swing through midwest... (Read More)
Harrison, Ohio (MacRumors.com by )– August 24, 2017 - Tim Cook Hits the Road to Visit Testing Equipment Manufacturer CTS in Cincinnati. (Read More)
CTS Acquires H. Schreiner to Increase Business
Opportunities in European Automotive, Industrial, and Medical Markets
Harrison, OH – March 1, 2017 ─ Cincinnati Test Systems (CTS) announces the acquisition of
H. Schreiner, a designer and manufacturer of leak test instrumentation and special purpose testing machinery. Schreiner has been in business for over 40 years, located in Ottobrunn, Germany. The new CTS Company will operate at that location under the name Cincinnati Test Systems - Schreiner GmbH.
Kevin Hansell, President of CTS said, ‘Bringing H. Schreiner into the CTS organization establishes an immediate CTS presence in European market. It has been part of the CTS strategic plan to enhance the company’s future growth and performance in Europe and this acquisition is a significant step in that direction.’
With almost no overlap in the markets served, both CTS and Schreiner product lines will remain available for the foreseeable future. ‘It is our intent to utilize our combined sales channels to promote both companies. As we move forward, we will take every opportunity to grow these businesses together in a way that provides the most value to our customers in the global test market’, said Hansell.
Since 1981 Cincinnati Test Systems (CTS) has manufactured test instruments and custom leak test systems and supports over 25,000 test applications around the globe. CTS specializes in the manufacture of leak test instrumentation and test systems, has over 230 employees, and has significant operations in the US, Mexico, China, and Korea. CTS is a division of the TASI group of companies, which employs over 800 employees globally.