Leak Detection Associates Announces New SIMS 21 CFR Part 11 Compliant System Software

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Meeting the strict regulatory demands 21 CFR Part 11 requires is a critical factor in terms of quality system compliance and LDA is proud that we can deliver a solution that exceeds client and regulatory agency expectations

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Dedicating the time and resources to development of a complete Part 11 compliant instrument operation program allows us to stand as a leader in the marketplace and deliver a solution to exceed client expectations

Leak Detection Associates (LDA), the world’s premier manufacturer of custom built, helium-based leak testing instruments for the Pharmaceutical, Biotechnology, Medical Device and Food Packaging Industries is pleased to announce the release of its new SIMS Version 1.11.19 21 CFR Part 11 compliant software program specific to the custom-built helium leak testing systems it designs and manufactures. The new program, which was developed to support both existing SIMS 1284+ models and the new SIMS 1915+ units, makes LDA the sole marketplace supplier of helium-based leak testing systems that meet all of the 21 CFR Part 11 software requirements as dictated by the Food & Drug Administration (FDA).

“Meeting the strict regulatory demands now in place for any computer-driven analytical instrument is a critical factor in terms of quality system compliance. Dedicating the time and resources to development of a complete Part 11 compliant instrument operation program allows us to stand as a leader in the marketplace and deliver a solution to exceed client expectations, ” commented Alan Weiss, Chief Financial Officer of LDA.

Over the past twenty years, with the increasing use of computer systems and electronic records, the FDA has issued a number of guidance documents and directives that outline specific requirement for electronic data management. Systems must account for multiple level login of users, application of electronic signature and approval, secure data management that prevents alteration of existing results and an electronic audit trail that records all relevant events in a time and date stamped pattern. Contracting with a development team that specializes in development of instrument operation software programs and with extensive experience in the Part 11 area, LDA was able to design a robust and comprehensive program specific to helium leak testing on our custom-designed and manufactured systems, while improving functionality and usability compared to existing software options.

For existing SIMS units in the marketplace, LDA is offering a system software upgrade program for easy installation performed onsite for a client’s existing install base. All new instruments ordered, inclusive of new models – the SIMS 1915+ and SIMS 1915+ LT – will come with the new 21 CFR Part 11 program.

About Leak Detection Associates, LLC
For over 20 years, Leak Detection Associates has been the premier manufacturer of custom helium leak detection instruments for the pharmaceutical, biotechnology, medical device and food packaging industries. LDA's well-established technology has been incorporated into ASTM and compendia guidance documents. This robust industry experience, combined with the advanced capabilities of its newest model the SIMS 1915+ helium leak detection unit, provides companies with tools to quantitatively evaluate leakage, improve the package development cycle, establish manufacturing controls, and ultimately reduce risk to the product and consumer throughout the lifecycle.

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Brian Mulhall
Leak Detection
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