Software Integrators

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Software

Archiving / Mirroring

Calibration Software

CAPA Software

Change Control

Clinical Research

Content

Complaints

Data Management

DCS

Desktop Security

Document Control

Data Management

Encryption Software

EMS / BMS

ERES Software

ERP Software

Fire & Security

Lab. Instrumentation

LIMS

Maintenance

MES

Process Control

Lifecycle

Project Management

SCADA

SPC

Training

Validation Tools

Vision Systems

 

Environmental / Building Management or Monitoring Software

 

 

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.

 

 

Environmental Monitoring Software:

 

 

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 LoggerACR 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
EMSSCompliance 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 LabWatchThe 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 ManagerTISCOR 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.

 

If you are experienced in using one of the software packages listed below and would like to rate the product while sharing your comments and experiences with other visitors, please submit a comments form at the base of this page.

 

If you are a Pharmaceutical, Medical Device, Clinical or Quality Management Systems and Software manufacturer and feel that the details provided are inaccurate, please click here. Alternatively, if you wish to add your software and provided that it is genuinely designed to meet the Life Science Industry regulatory requirements, why not click here!

 

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