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

Sunday Business Systems offers two very similar products for different levels of compliance.  The SBS Quality Database and the SBS Q-Med Database both offer solutions for Corrective and Preventive Actions (CAPA), Non-conformance management, audit management, etc. (refer to the Feature Comparison Table. The Quality Database was designed for basic compliance where there are less rigorous requirements.  The database is an excellent source of objective evidence that, for instance, corrective actions were completed and they were effective.  The recorded data is sufficient to show the results and efficacy of the Corrective action program. The SBS Q-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 … Continue reading Tech Note: SBS Quality Database and Q-Med Compared

14-Mar-2016 Sunday Business Systems, a leader in affordable and efficient software tools for quality management systems, is proud to announce the latest release of SBS T-Med Database.  This new release is ideal for FDA regulated companies that must manage employee training records. The T-Med Database is an ISO 13485 compliant program used to track employee roles and responsibilities, position training requirements, certification, re-certification, and training events. Simple reports show when re-certification is due or nearly due. Scan and link class rosters, certification checklists, and test results to create an efficient paperless system.  The program has a rich set of reports including employee training history for periodic evaluations or reviews. Measure training effectiveness with a click of a button.  It utilizes … Continue reading Press Release: T-Med Database Release

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