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A new solution developed by Stelex Inc.® (Bensalem, PA) addresses the problems faced by pharmaceutical and medical device companies that must bring existing or legacy systems into compliance with the FDA's 21 CFR § 11 regulation on Electronic Records and Electronic Signatures.

Stelex's ComplianceBuilder, The Turnkey Part 11 Solution, was created exclusively to address compliance with 21 CFR § 11. This solution enables pharmaceutical and medical device companies with existing automated systems to meet the intent of 21 CFR § 11 regulation while preserving their original automation investment.

"As a consulting firm for FDA-regulated industries that actively monitors the progress of 21 CFR § 11, it was only natural that we should anticipate our clients' needs and develop the ComplianceBuilder Solution," said Michael Kavinson, CEO of Stelex. He added, "The ComplianceBuilder Solution is yet another example of Stelex's innovative and cost-effective answer to our clients' business problems."

Stelex offers the ComplianceBuilder Solution in two versions, ComplianceBuilder/File and ComplianceBuilder/SCADA. ComplianceBuilder/File is designed for Instrument Data files, Datasets, MS Word, MS Excel or any other document format. ComplianceBuilder/SCADA is designed for PLC, DCS, SCADA and MES Systems. Both versions create a central archive for all documents in a secure central database.

The ComplianceBuilder Solution's Patent Pending technology provides audit trail capabilities, captures electronic signatures, enforces robust security, and ensures full compliance with 21 CFR § 11. The ComplianceBuilder Solution integrates seamlessly with existing systems, making it a cost effective solution to the 21 CFR § 11 issue.

Stelex is a consulting firm providing quality solutions to FDA regulated companies and mission critical environments for over 15 years. Stelex commands a through understanding of federal regulations and industry accepted software development standards. Stelex has the proven ability to assist corporations with Quality Auditing Services, System Development, e-Enterprise solutions, System Validation services and Training. The company is focused on providing timely and comprehensive solutions within ever changing technological and regulatory environments.

For more information:

Daniel R. Matlis
Stelex Inc.
Two Greenwood Square, Suite 310
3331 Street Road, Bensalem, PA 19020
215-638-9700 x-120 / 215-638-9333 (fax)
dmatlis@stelex.com

Source: Stelex Inc.

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