Integrated QMS & ECO/ECR
- Full suite QMS integrated to the ERP system, failed inspections auto-initiate NCR process, link CAR / CAPA to NCR, perform root cause analysis, track customer complaint/satisfaction cases, control tool calibration/maintenance scheduling. Using controlled software processes earns you easy pass at ISO, API spec Q1/Q2, FDA audits and more.
- NCR system designed specifically for regulatory compliance; collect information, control process, and enforce controls; access quality data easily with graphs, reports, and easy excel exporting. Automatically generate NCRs with source details upon any inspection failure; track exceptions in a centralized NCR system; route NCRs via auditable workflow control and automated email notifications to appropriate dispositions and department.
- CAR/PAR/CAPA system designed specifically for regulatory compliance. Automatically link out to CARs (corrective action reports) to resolve NCRs; optional 8D (eight disciplines) tracked to CAR resolution; root cause analysis tools within CARs / PARs
- Root cause analysis tools within CAR / PAR process designed specifically for regulatory compliance.
- Log inspections directly from work orders (e.g. receiving, in-process, final), pass/fail rates, failure codes, and more to create detailed reports on inspection activity; maintain your own database of inspection failure codes. Require (i.e. system enforce) critical steps in inspection instructions, work instructions, job checklists and data collection sheets delivered electronically to shop floor; automatically generate NCRs with source details upon any inspection failure.
- Engineering Change Orders - robust, clean, controlled ECO process built in and intelligently integrated. Manage all affected components, higher-level BOMs, open work orders for the material, etc. Route ECO through various stages departments in workflow, ping assignee with email alert and “nag” notifier, report on ECO assignment history, etc. Achieve controlled process for rev rolls.