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Information Security, Electronic Records and Electronic Signatures in SBS Products

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

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 … Continue reading Training and T-Med Databases Compared

Tech Note: SBS Quality Database and Q-Med Compared

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