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

Sunday Business Systems is proud to announce the latest release of the Quality Database. Version 4.95 improves the user experience, fixes minor bugs, adds checks for data integrity, and adds new NC reports.

  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

The FMEA Database is simple, inexpensive, ISO 9001 compliant software that uses Failure Mode and Effects Analysis (FMEA) as a risk management technique. It is ideal for the requirements of ISO 9001:2015.

KEY FEATURES Implement Risk based strategies for ISO 9001:2015 Identify failure modes for each process or item Identify failure effects and severity Identify causes and frequency Identify current controls and detection levels Develop multiple actions associated with this failure mode Assign owners and due dates Establish verification and validation criteria Electronic signature for management approval Rich set of reports Track open actions and delinquent due dates BENEFITS Save time and reduce the cost of compliance to Quality Standards such as ISO 9001:2015 Implement Risk Based Thinking Easy to use Collaborative platform Simple, menu driven user interface Easy to train users Convenient, intuitive forms Can restrict users to control data integrity Rich set of reports Easy to identify delinquencies, stalled actions … Continue reading Risk Management

Founded in 2004, Sunday Business Systems provides cost effective quality management software and training services to improve compliance to quality standards such as ISO 9001, AS9100, TS16949, ISO 13485, ISO 14001, and API Q1. SBS provides QMS (Quality Management System) software solutions for: Document control Corrective and preventive action management Risk management (FMEA / SWOT) Non-conformance tracking Audit Management Control of calibrated equipment Employee training management Supplier management Preventive Maintenance Control of Calibrated Equipment Inspection Data management, control plans, and SPC Environmental Management System compliance (ISO 14001 EMS) Occupational Health and Safety (OH&S) Management System compliance (ISO 45001 OH&S) Context of the organization including interested parties Business Continuity Planning In addition to our standard products, we use our extensive manufacturing … Continue reading About Us