Handle out of specification results with ease
Improve safety and compliance with better OOS management
Out of specification is a result that falls outside the predetermined specifications or established acceptance criteria set by the manufacturer and/or the laboratory. Our OOS application helps establish a streamlined system through a defined procedure to reduce paperwork and minimize manual interventions and errors.
Improve process outcomes and ensure compliance with OOS
Streamline and digitize the process to manage out of specification incidents
Quickly and efficiently log and categorize incidents
Assess OOS impact and investigate root cause to initiate CAPA
Improve transparency in the system with timely access to data – even the archived historical records
Understand OOS trends with in built analytical tools
Quickly process incidents, get approvals, and ensure timely action with a digital workflow
Work with a regulatory compliant application
Work with a regulatory-compliant application
Comply with storage requirements of electronic CAPA records and maintain data integrity
Testimonial
The Audree Infotech
Advantage
21 CFR part 11, GAMP 5, and other regulatory compliant
On-going support and user training
Host application on cloud, on-premise, or in a hybrid model
End-to-end validation before go-live
Highly customizable apps as per client processes
Complete suite of pharma apps
Expert-led process consulting
Seamless integration
Faster change request management
Other Applications
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