Audit Management
Manage Your Audit Programs. Electronically
Montrium’s Audit Management application allows life sciences organizations to identify operational & compliance risks through structured audit information. Based on industry standards and best practices, the audit management module is designed to assist auditors in the planning and execution of audits through the use of workflow based tasks and integrated GxP audit checklists. Audit observations can be easily captured, tracked and trended both for internal and external audit thereby eliminating time-consuming paper-based processes.
Pairing the Audit Management solution with the implementation of the CAPA Connect, life science organizations can improve the tracking and trending of quality issues as they happen. Although this is the scenario most strive for, it is only really with an integrated quality management system and a holistic approach, that this can be achieved.
Ensure that GxP Audits are faster, easier, and more effective
Auditing is an important part of ensuring regulatory compliance and can also generate a significant body of information around GxP activities. Audit reports have, however, typically been very unstructured and paper based. Being able to structure and mine audit information can lead to the discovery of important trends and signals which need to be actioned through the quality system. Using audit information to assess past performance and future potential of suppliers and sites is also extremely beneficial and having structured audit data helps us do this. Finally, audit observations need to be managed and corrective actions put in place so ensuring integration with CAPA is key.
Perfect For
- Pharmaceutical Organizations
- Contract Research Organizations
- Manufacturing Organizations
Built to
- Automate audit reporting
- Simplify audit planning and scheduling
- Centrally track and trend observations
Take the tour
Manage the entire audit process
Audit Program Management
Plan your audit programs and centrally allocate auditors. Generate audit plans and inform auditees automatically.
Structured Audit Checklists
Build your own audit checklists to allow for structured capture of all audit findings and observations.
Register and Track Observations
All observations made within a checklist or entered directly in the system can be tracked and trended in one location.
Manage audit data in one place
Structured Forms
All audit information is captured in a structured form which means that data can be queried and used not only to generate audit reports but also for trending.
Reports & Dashboards
Predefined KPIs and the ability to export audit data to Microsoft Excel to produce in-depth analysis and reports give you the tools to proactively manage audit observations.
Audit Checklists
Build and manage audit checklists for all areas of GxP operations in one central place to ensure that audit information is structured and standardized.
Compliance
Centralized tracking of audit programs and audit observations enables you to easily identify potential GxP compliance issues and ensure corrective actions are put in place.
Improve audit scheduling.
Automated Email Alerts
Auditors and auditees receive notifications of when audits are scheduled or if any schedule changes are made.
One simple calendar
It is easy to see which audits have been planned or are incoming in the central audit calendar.
Manage audit resources
Centrally manage all audit resources in one easy to navigate calendar.
Streamline the way you manage Corrective and Preventive Actions.
Integrated with CAPA Connect
Pairing the Audit Management solution with the implementation of the CAPA Connect, life sciences organizations can improve the tracking and trending of quality issues effectively, as they happen.
Centralize All Observations
Manage and view all audit observations and associated corrective actions in one central list with advanced filtering, search and views.
Import and Export Observations
You can easily import and export observation lists from the system to and from Microsoft Excel.
Packed Full of Other Functionality
20+ Audit Checklists
Our solution comes preloaded with over 20 standard GxP audit checklists to get you started
Audit Workflow
A fully automated workflow manages the audit process from A to Z
Email Alerts
Automated email alerts can be sent to notify participants of audit activities and corrective actions
Real-time KPIs
KPIs provide you with insight into the health of your audit programs in real-time
Mobile Friendly
Audit checklists can be completed on the go with your tablet or mobile device
PDF Rendering
PDF versions of audit reports can be generated automatically for filing and distribution
Program Planning
Manage your complete audit program in the central audit calendar
Digital Signatures
Integrated digital signatures allow you to digitally sign audit reports in your browser
Excel Export
Export audit observations and corrective action plans directly into Excel for reporting