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

  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

  KEY FEATURES   Control of Calibrated Equipment Record calibration / validation history Generate a Recall Report for “Out of Cal” Equipment Record calibration / validation measurement values Document responses when measuring equipment is found to be unfit for its intended purpose Generate calibration certificates Review detailed calibration reports Preventive Maintenance Create Preventive Maintenance Schedules Define Preventive Maintenance Checklists Track Unscheduled Maintenance Generate Fix-It-Tickets Control Miscellaneous Assets Rich set of reports for detailed analysis Install on your local server or leverage our Cloud QMS solution BENEFITS Build a simple and effective Quality Management System (QMS / eQMS) Efficient and Cost Effective Simple, low cost solution Saves time and improves efficiency Reduce risk through proper preventive maintenance Effective QMS Control calibrated … Continue reading Asset Tracking Database

KEY FEATURES SBS Training Database is ISO 9001 compliant software used to track employee training events, position requirements, certification, and re-certification. Report training gaps and key metrics. Manage Training Records Define Job Descriptions / Roles and Responsibilities Define Training requirements by position (standard training for each position) by employee (special training for each employee) for the release of controlled documents Certification Requirements Re-Certification Requirements Document revisions trigger training requirements Email Reports directly to affected employees User login: define user passwords and privileges Install on your local server or leverage our Cloud QMS solution Compare the Training Database to the T-Med Database BENEFITS Build a simple and efficient Quality Management System (QMS / eQMS) Efficient and cost effective Simple, low cost … Continue reading Training Database

KEY FEATURES SBS Ground Control is your Document Control and Employee Training Management solution. Document Control Complete document lifecycle management Controls any electronic document including Microsoft Office files, Word, Excel, PowerPoint, PDF, AutoCAD, SolidWorks, etc. Control document releases New documents Document Revisions Expired and Obsolete documents Ensure approvals are documented Capture electronic signatures Email alerts to notify reviewers Organize electronic documents Organize by Type, Department, and Owner Group related documents for quick reference Document releases trigger training requirements User login: define user passwords and privileges Simple, effective reports Ensure the effectiveness of your document control system   Training Management Manage Training Records Define Job Descriptions / Roles and Responsibilities Define Training requirements by position (standard training for each position) by … Continue reading Ground Control

KEY FEATURES ISO 9001 compliant vendor management software used to establish criteria for selection, evaluation and re-evaluation of suppliers: Develop Vendor or Supplier qualification plans Record qualification results Maintain your Approved Vendor List (AVL / ASL) Establish criteria for selection, evaluation and re-evaluation of suppliers Maintain a supplier qualification history / supplier performance records Generate vendor ratings or graded score cards Link electronic files (paperless system) A rich set of reports for Vendor status, gaps, and performance Define user passwords and privileges for secure log in Install on your local server or leverage our Cloud QMS solution BENEFITS Build a simple and efficient Quality Management System (QMS): Comply with standard Purchasing requirements of ISO 9001:2015 AS9100 IATF 16949:2016 ISO 13485 … Continue reading Vendor Management

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.

28-Apr-2017 Sunday Business Systems is proud to announce the latest release of the Asset Tracking Database (version 2.71). This new release is ideal for companies striving to maintain compliance with the ISO 9001:2015 standard. The Asset Tracking Database is an affordable software tool used to manage calibrated equipment, reduce risk through preventive maintenance, and manage unscheduled maintenance. The program has a rich set of reports including calibration recall lists and preventive maintenance schedules. The latest release includes: Added a priority field to the unscheduled maintenance module Improved reports Minor bug fixes and enhancements Free trial downloads are available from our website for a no risk evaluation: https://sundaybizsys.com/asset-tracking-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 Develop Vendor qualification plans Record Vendor qualification results Maintain your Approved Vendor List (AVL) Establish criteria for selection, evaluation and re-evaluation of suppliers Link electronic files (paperless system) Rich set of reports User login: define user passwords and privileges BENEFITS Build a simple and efficient Quality Management System (QMS) Comply with standard Purchasing requirements Efficient and cost effective A vital tool to ensure ISO 9001:2015, AS9100, ISO/TS 16949, API Q1 compliance Paperless system

KEY FEATURES Control of Calibrated Equipment Recall Report for “Out of Cal” Equipment Preventive Maintenance Schedules Track Unscheduled Maintenance Generate Fix-It-Tickets Control Miscellaneous Assets User login: define user passwords and privileges BENEFITS A Vital Tool to Ensure ISO 9001:2015 Compliance Build a simple and efficient Quality Management System (QMS) Efficient and Cost Effective Paperless System

DOCUMENT CONTROL & EMPLOYEE TRAINING MANAGEMENT Complete document life cycle management Controls any electronic document including Microsoft Office files: Word, Excel, PowerPoint, PDF, AutoCAD, SolidWorks Control document releases Electronic signature approvals are recorded Document Index New document revisions trigger training requirements Simple, effective reports Measure the effectiveness of your document control system Manage employee Training Records Define Job Descriptions / Roles and Responsibilities Define Training requirements Manage a Training Schedule Certification Requirements Re-Certification Requirements Supports self-paced (CBT) and instructor-led training Email Reports directly to affected employees BENEFITS A vital tool to ensure ISO 9001:2015, AS9100, and ISO/TS 16949, API Q1 compliance Efficient and cost effective Simple document life cycle management Build a simple and efficient Quality Management System (QMS) The … Continue reading Ground Control

KEY FEATURES Manage Training Records Define Job Descriptions / Roles and Responsibilities Define Training requirements Certification Requirements Re-Certification Requirements Document revisions trigger training requirements Email Reports directly to affected employees BENEFITS Efficient and cost effective A vital tool to ensure ISO 9001:2015, AS9100, and ISO/TS 16949 compliance Build a simple and efficient Quality Management System (QMS) Paperless QMS

KEY FEATURES Non-conformance Tracking and Analysis Corrective Actions Supplier Corrective Actions (SCAR) Safety Corrective Actions Preventive Actions Risk Management – FMEA and SWOT Analysis Internal audits Document Management Review Meetings Customer Satisfaction Surveys Email reports directly to employees Define user passwords and privileges BENEFITS A vital software tool to ensure ISO 9001:2015, AS9100, ISO/TS 16949, API Q1 compliance Improve Customer satisfaction Build a simple and efficient Quality Management System (QMS) Paperless QMS Efficient and cost effective