
Please find below our listing of possible software solutions for the Pharmaceutical, Medical Device or Life Sciences Industry wishing to comply with the FDA, TGA, MHRA regulations.
| Vendor | Claim | Website |
| QSI System, | Designed specifically to meet the requirements of ISO 9001:2000, the QSi System for Quality Management helps your organization reap the benefits of ISO certification, including improved customer satisfaction and reduced costs. | www.qualitysys.com |
| TrendReader Standard Data Logger | ACR Systems TrendReader Standard Data Logger Software, includes data validation that permits our software and hardware to conform to the FDA’s 21 CFR Part 11 regulations. Data viewed on either the PC or printed form is authentic by providing a data file sign-off mechanism, a CRC check (Cyclic Redundancy Check) for data integrity, and an overall data validation pass/fail statement with sign-off right on the graph. | www.acrsystems.com |
| EMSS | Compliance Software Solutions Corporation (CSSC) has developed the Environmental Monitoring Software System (EMSS©) to comply with the requirements defined in the FDA’s 21 CFR Part 11 for Electronic Documents | www.csoftsol.com |
| Validator 2000 LabWatch | The Validator 2000 meets all the new FDA regulations for thermal validation, including 21 CFR Part 11 on electronic signatures and records. It provides many time-saving benefits such as automating sensor calibration and report generation. The LabWatch System operates in compliance with the FDA regulation on 21 CFR Part 11 Electronic Signatures and Records | www.kayeinc.com |
| Inspection Manager | TISCOR designs software for hand-held computers for technicians performing site and equipment inspections. TISCOR solutions prove compliance and prevent the falsifying of records. Among TISCOR's many products is Inspection Manager, which effectively addresses 21CFR Part 11 | www.TISCOR.com |
The above table lists all the Software identified by PharmOut Information Technology.
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