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Training and T-Med Databases Compared

Posted on March 15, 2017November 9, 2017Author AndrewCategories BlogTags 21 CFR Part 820, Audit trail, certification frequencies, CFR21 Part 11 compliant, Change history Log, compliance to FDA standards, define qualifications, defining roles and responsibilities, document revision changes, electronic documents, electronic records, electronic signatures, Email reports, Employee Positions, employee roles and responsibilities, Employee training management, Export reports to excel, FDA regulation, inactivity monitor, ISO 13485, Management dashboard, measures of effectiveness, measures of training effectiveness, Password encryption, password expiration, prerequisites, Privilege based user login, Quality Management Standards, recertification frequencies, Record training events, recording training history, Reports and analysis, required Training, SBS T-Med Database, SBS Training Database, Tobjective evidence, training, training classes, Training gap reports, Training history reports, training programs, training records, training requirements, Training requirements reports, training schedule, training skills, user privileges

Training and T-Med Databases Compared

Sunday Business Systems offers two very similar products for employee training management for different levels of compliance.  The SBS Training Database and the SBS T-Med Database both offer solutions for defining roles and responsibilities, training requirements, and recording training history, etc. (refer to the Feature Comparison Table).

The Training Database was designed for basic compliance where there are slightly less rigorous requirements.  The database is an excellent source of objective evidence that training programs have been defined and are being executed in an efficient manner.  It is also an invaluable tool to ensure measures of training effectiveness are maintained.  Both an Access stand-alone version and a SQL version for enhanced security and performance are available.

The SBS T-Med Database was designed for rigorous compliance to FDA standards (21 CFR Part 820 and ISO 13485) with CFR21 Part 11 compliant electronic records and electronic signatures.  Electronic signatures are required for approving training events and document revision changes.

The T-Med database also is more secure, with password expiration, account locking, and an inactivity monitor.  Companies subject to FDA regulation may use the advanced features of the SBS T-Med Database to show strict compliance to the Quality Management Standards.

The product feature comparison is shown below:

Feature Training Database T-Med Database
Employee Positions  
Define prerequisites / qualifications x x
Define employee roles and responsibilities x x
Define required Training for each position x x
Employees may hold multiple positions x x
Training records
Create a training schedule (of future events) x x
Record training events x x
Scan and link electronic documents such as signed rosters x x
Scan and link test results and other measures of effectiveness x x
Reports and analysis
Management dashboard showing overall compliance  o x
Training history reports x x
Training gap reports (what is needed) x x
Training requirements reports x x
Export reports to excel, word, PDF x x
Email reports with a single click x x
Microsoft access (stand-alone) database x  o
General  
Create training classes (courses) x x
Define certification and recertification frequencies x x
Group classes into training skills x x
Maintain headcount reports x x
Privilege based user login x x
SQL based (Access front end / SQL back-end) optional x
Change history Log / Audit trail   x
Detailed user privileges (add/edit/delete / approve)   x
Password encryption and expiration   x
Inactivity monitor   x

 

Click here to see the full report.

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API Q1 AS9100 asset management Asset Tracking Database Audit Management Calibration Calibration Software CAPA CAPA Software certification Corrective Actions Document control employee training history Employee training management Employee training plan enterprise quality management software eqms FMEA FMEA Risk management ISO 9001 ISO 9001 compliance software ISO 9001:2015 ISO 9001:2015 software ISO 13485 Learning Management System LMS manage employee training records new release Paperless QMS Preventive Actions Preventive Maintenance QMS QMS Software quality management system quality management systems Risk analysis Risk Based thinking Risk Management Sunday Business Systems Supplier management SWOT Analysis track employee roles and responsibilities Training Database training requirements TS16949
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