05-Jan-2018 Sunday Business Systems is proud to announce the release of version 3.40 of our Training Database. This new release is designed to improve the user experience by adding new buttons to show key forms in datasheet view, new reports. The new release also includes performance enhancements and minor bug fixes. Click here for free demo downloads. Key changes: Add datasheet view to key forms Add buttons to standardize forms Add manager reassignment function (reassign employees to a new manager if manager leaves company) Add document revision field to Gaps reports Add new history, gap, and requirement reports organized by manager Add criticality field to align with risk based thinking of ISO 9001:2015 Background: The SBS Training Database is an … Continue reading SBS Training Database version 3.40 released

  KEY FEATURES     FMEA = Failure Modes and Effects Analysis Risk Assessment: Failure Modes and Effects Analysis (FMEA) Implement risk based strategies for ISO 9001:2015, ISO 14971 Identify failure modes for each process or item Identify 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 User login: define user passwords and privileges Rich set of reports Track open actions and delinquent due dates ADVANTAGES Build a simple and efficient Quality Management System (QMS) Implement risk based thinking required by ISO 9001:2015 Easy to use Collaborative platform Simple, menu driven user interface Easy … Continue reading FMEA Database

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

  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 Preventive Action results Management review or MRB meetings Nonconformances Customer satisfaction surveys Improve … Continue reading Q-Med Database

  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 Meeting Manager Customer Satisfaction Surveys email reminders for open CARs, open actions, etc. Rich set of reports and analysis tools for each module BENEFITS Build a simple and efficient Quality Management System (QMS / eQMS) 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 Saves time and improves efficiency Answers are a click away Quality effectiveness Analyze graphs, charts, and reports on demand Report corrective and preventive action … Continue reading Quality Database