KEY FEATURES Nonconformance Tracking and Analysis Closed loop Corrective Actions with Validation and Verification (CAPA) Audit Management Risk Management (FMEA and SWOT Analysis) Continual Improvement Projects Preventive Actions QMS Tools: Context of the Organization, Interested Parties, QMS Scope Meeting Manager Customer Satisfaction Surveys Environmental Health and Safety (EHS / HSE) management email reminders for open CARs, open actions, etc. Rich set of reports and analysis tools for each module Locally installed or Cloud-based solutions available BENEFITS Build a simple and efficient Quality Management System (QMS) Improve customer satisfaction Quickly and effectively respond to customer complaints Rebuild customer confidence when things go wrong Monitor Customer Perceptions and take action to improve Efficient and cost effective Simple, low cost solution … Continue reading Quality Database
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
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