KEY FEATURES Real-time Statistical Process Control (SPC) Configure Collect data for parts and/or processes Define limits: valid data, specification, and control Chart Display options Collect and validate data against Control Limits Spec Limits Correlate data to process, part #, serial number or work order Real-time SPC Control Charts – generates warnings for spec / control limit violations Simple reports show summary statistics including Cp, Cpk Export raw data to Excel, Word, etc. Unlimited users, no per user licensing Ideal for Final QC data entry BENEFITS Efficient and cost effective Simple, low cost solution Saves time and improves efficiency Eliminates paper records A vital tool to ensure ISO9001 compliance Implements basic data collection and validation to ensure product compliance Eliminates paper … Continue reading SPC Keeper

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

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable FDA regulatory requirements. SBS Software tools help with efficient compliance to ISO 13485: SBS Product Key Features T-Med Database · Maintain training records · Record certification and re-certifications · Evaluate training effectiveness · Email delinquency notices · Manage training compliance · CFR 21 part 11 compliant Q-Med Database · Manage corrective actions (CARs) – Safety and Supplier CARs (SCARs) · Manage preventive actions (PARs) · Internal audit management · Document Quality Management System reviews · Manage continual improvement projects · Monitor and measure customer perceptions · Manage and assess risk … Continue reading ISO 13485

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 Health and Safety (EHS / HSE) management Context of the organization including interested parties Business Continuity Planning Occupational Health and Safety compliance (ISO 45001) In addition to our standard products, we use our extensive manufacturing operations experience to … Continue reading About Us