KEY FEATURES SBS T-Med Database is ISO 13485 compliant software used to track employee training events, position requirements, certification, and re-certification. Report training gaps and key metrics. Manage Employee Training Records Define Job Descriptions / Roles and Responsibilities Define Training requirements by position (standard training for each position) by employee (special training for each employee) for revision controlled documents Certification Requirements Re-Certification Requirements Document revisions trigger training requirements Email Reports directly to affected employees Electronic signature approvals User login: define user passwords and privileges CFR21 Part 11 compliant Install on your local server or leverage our Cloud QMS solution BENEFITS Build a simple and effective Quality Management System (QMS / eQMS) Efficient and cost effective software Simple, low cost solution … Continue reading T-Med Database

News reports of data breaches, hacks, and other system intrusions continue on a regular basis. It is critical that software designers build secure databases that are highly resistant to hackers and meet information security standards. Both CFR 21 part 11 and ISO/IEC 27001 establish requirements for secure information systems and electronic records. CFR 21 part 11 is part of the Code of Federal Regulations that establishes the US Food and Drug Administration (FDA) electronic records and electronic signatures requirements. ISO/IEC 27001 specifies the requirements for establishing, implementing, maintaining and continually improving an information security management system within your organization. SBS essentially offers two levels of databases.  While security is critical, cost and connectivity important factors. SBS standalone databases require username … Continue reading Information Security, Electronic Records and Electronic Signatures in SBS Products

Free Demo Downloads – try before you buy! We believe software must be experienced before you can make a good purchasing decision. Accordingly, we provide free, full-featured demo versions of our standard products that may be downloaded and evaluated prior to purchase. SBS Product Key Features Training Database · Maintain training records · Record certification and re-certifications · Evaluate training effectiveness · Email delinquency notices · Manage training compliance T-Med Database · Ideal for FDA regulated industries · Manage training compliance · Maintain training records · Record certification and re-certifications · Evaluate training effectiveness · Email delinquency notices · CFR 21 Part 11 compliant Quality Database · Manage corrective actions (CARs) · Manage preventive actions (PARs) · Track Non-conformances · Internal … Continue reading Demos

KEY FEATURES Nonconformance Tracking   Escalate a Nonconformance to a Corrective Action Corrective Actions (CAPA)   Safety, Supplier, Internal Audit CARs   With Validation and Verification   Approvals require electronic signatures Preventive Actions (PA) Audit management   Record audit findings   Manage Audit Schedules   Escalate to a Corrective Action or Preventive Action Meeting management Project management Customer satisfaction surveys CFR21 part 11 compliant security, activity logs, audit trails BENEFITS Complies with requirements of   ISO 13485, 21 CFR Part 820, ISO 14971   ISO 9001:2015   AS9100   ISO/TS 16949 Provides a concise, electronic record of historical events, actions, and improvement   No paper to get lost Efficiently maintains quality records   Internal audits   Corrective Action results   … Continue reading Q-Med Database