You can specify unique, time-based intervals based on the product, process, or even the workstation. Windows automatically pop up, clearly identifying when data collections are due. If a failure is detected or if no data is collected, ProFicient can automatically send notifications, email administrators, or even force users to specify assignable cause codes and corrective actions.
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With ProFicient, audits are easier with instant access to quality records and electronic documentation needed to demonstrate compliance. ProFicient is a robust solution that can stand up to third-party certification audits or internal audits for Quality Management Systems (QMS) that require ISO 13485:2012, Good Manufacturing Practice (GMP), or ISO 9001 as required by the FDA, Health Canada (CMDCAS), EMA, Japanese PAL, EU Directive 90/385/EEC, ICH Q10, or other agencies. Creating reports takes only minutes instead of hours or days, eliminating the need for spreadsheets.
ProFicient boasts built-in checklist- and workflow-alerting features needed to comply with Hazard Analysis and Critical Control Points (HACCP) and Standard Operating Procedures (SOP). With ProFicient, you can incorporate workflow requirements at the production-floor level, providing automatic data collection prompts to operators. InfinityQS’s real-time Dynamic Scheduler
offers visual checklists to operators, reminding them when to perform HACCP, SOP, and other critical quality checks.