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

Corrective and Preventive Actions Follow an 8D problem solving process to fix problems (corrective actions) so they never happen again. Reduce the risk of future problems (preventive actions) by asking “what can go wrong?” and fixing the issue before it harms the organization. Rich set of reports to track and analyze performance drive actions to completion trend CARs and associated cost CAPA (Corrective And Preventive Actions) modules are available in both the SBS Q-Med Database and the SBS Quality Database: The SBS Q-Med Database is ideal for FDA regulated industries (Medical Device, Pharmaceuticals) The SBS Quality Database is designed for Manufacturing, Aerospace, Service and other industries. Click here for a full list of features and a detailed comparison of the … Continue reading Corrective And Preventive Actions