CTS leak instrument eases regulatory compliance for medical device manufacturers

May 14, 2019 | By Cincinnati Test Systems

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.

Administrator Configurable
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.

About CTS

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.

Media Contact:
Leo Valiquette
(613) 769-9479