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 signatures. Electronic signatures are required for approving several different stages of the Corrective Action. Containment approval, Corrective Action Plan approval, verification/validation approval, and final closure approval all require electronic signatures. This documents a more structured process for each of the steps. The Q-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 Q-Med Database to show strict compliance to the Quality Management Standards.
Feature Comparison Table
|Feature||Quality Database||Q-Med Database|
|Nonconformance Tracking and Analysis||●||●|
|Nonconformance Approval (via electronic signature)||○||●|
|Disposition Approval (via electronic signature)||○||●|
|Containment approval (via electronic signature)||○||●|
|Action Plan approval (via electronic signature)||○||●|
|Action validation approval (via electronic signature)||○||●|
|Closure approval (via electronic signature)||○||●|
|Supplier Corrective Actions (SCAR)||●||●|
|Continual Improvement Project Tracking||●||●|
|Audit Approval (via electronic signature)||○||●|
|Risk Management – FMEA||●||●|
|Risk Management – SWOT Analysis||●||●|
|SQL data security||optional||●|
|CFR21 Part 11 compliant||○||●|
|Account lock after excessive failed logins||○||●|