0 Auditing & Compliance Assessment Tool
Gain Real-Time visibility of your Audit Plan, Issue Reporting, and Remediation Status. Manage your entire internal audit Lifecycle in one place, assured by independent oversight from a sterilisation SME. Want to ensure your sterilisation process is compliant to the new Annex 1? Track in real-time your compliance position and be audit ready. Assign and track actions through to completion. Trend critical performance metrics for each steriliser, act before an issue becomes a problem! Self-Inspection – Compliance Audit Tool A pre audit questionnaire completed by the end user compiles all the required information to allow the sterilisation SME and/or AE(D) to review and prepare for the audit that they subsequently conduct. Both audit tools are simple to use, with standardised and straightforward radial choice selection options designed to verify a compliance position to the relevant clauses of Annex 1. There is also the ability to add explanatory text and drag and drop files and supporting evidence as appropriate. Monitoring Tool and Machine Metrics The monitoring tool sets schedules for ongoing self-assessment and tracks any actions arising to completion. The tool can also be used to capture critical performance parameters of your sterilisation process, (for example trend analysis of weekly leak rate results or cycle/phase durations, that can confirm consistent machine performance or otherwise). Audit Report The users on the account will be notified and receive the audit report electronically along with associated actions. A high-level Red/Amber/Green (RAG) rating includes the option to drill down into the audit topic subject areas where users can see the detailed observations and compliance risks. It is a simple visual and globally accessible platform giving a real-time risk overview, ideal as part of a level 1 or 2 Self-Inspection process, ensuring a consistent and ongoing audit and monitoring solution. Global oversight The power behind the compliance tool allows organisations to scale from a singular manufacturing facility and steriliser to multiple facilities and/or sterilisers. This allows stakeholders charged with global governance responsibilities to quickly ascertain compliance status across their site or sites, whether they are in a Quality or Engineering facing role. If you would like to see a demonstration of the system and discuss its suitability, please let me know. Paul and I would be happy to convene an initial Teams meeting at a mutually convenient time, email me at KJP@pavus.co.uk More details here: GMP Compliance Assessment Tool 1About Quiqsolutions Quiqsolutions is a leading provider of online quality management systems used by over 1000 organisations since 2011. In 2023 they were acquired by the Citation Group. For more information visit www.quiqsolutions.com