Software
Training Management 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.
Training Management Software:
| Vendor | Claim | Website |
| MasterControl™ | MasterControl™ integrated QUALITY and COMPLIANCE management software systems for FDA and ISO regulated industries. Integrated software systems include CAPA, Document Control, Training Management / Tracking, Change Control, Audits, Complaints Handling, eProcess Automation, Sarbanes-Oxley (SOX), etc. | www.mastercontrol.com |
| Training Tracker III | The Food and Drug Administration (FDA) mandates strict regulations regarding electronic signatures and audit trailing on electronic data collection methods under 21 CFR Part 11. Healthcare manufacturers using electronic record-keeping systems must comply with stringent regulations regarding the training of their employees, including the methods of recording and reporting such training for audits. Training Tracker III helps companies stay in compliance with these regulations by tracking employee training records and cross-referencing employees with their job titles / grades, courses required for those jobs, instructors and course scheduling. Once an employee's training has been completed, the information is recorded with the electronic signature, and all changes to that record are also date- and time-stamped for auditing purposes. | www.ihshealthgroup.com |
| ISOTrain | ISOtrain is a compliance driven training management software that meets government regulations, ISO 9000 standards and comprehensive validation protocols for a total quality based training. It has been developed based on industry reactions to government inspection observations (FDA, OSHA, EPA, etc.), 483's citations, and current or future client's requirements. Yes, ISOtrain is 21 CFR Part 11 compliant! | www.isotrain.com |
| Isotrain Training Management Solution | ISOtrain Training Management Solution is a powerful compliance driven, quality based training tracking system. ISOtrain allows you to manage employee training records on your global network. With a click of a button, you can notify employees of scheduled training, e-mail a report to management, review employee qualifications, or retrieve a course outline. ISOtrain runs on multiple desktop platforms, network operating systems and databases. Validation is made easy with a comprehensive validation package. | www.isotrain.com |
| SmartSolve | Pilgrim’s solutions help you effectively manage corrective and preventive actions (CAPA), investigations, customer complaints, internal and external assessments, document control, supplier quality, equipment calibration and maintenance, and employee training to help you produce the best products at the lowest cost. | www.pilgrimsoftware.com |
| ensur | Web-based quality management systems for FDA and ISO regulated companies. One platform provides document control, change control, complaint handling, investigations, CAPAs, employee training/certification tracking, product specification management, version control, and compliance testing. | www.mysticmsi.com |
The above table lists all the Software identified by PharmOut Information Technology.
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