OOS Troubleshooting Assist Pro App 1-Year License

OOS Assist Pro™ - Chromatographic OOS Investigation App (1-Year Licence, 2 Devices)

Description:

An OOS result lands on your desk. What do you check first and how do you prove it?

OOS Assist Pro™ gives your laboratory a structured, defensible path through every chromatographic out-of-specification investigation. Describe the failure in plain language, follow an engineered protocol of checks, record what each check actually showed, and generate the worksheets your investigation needs.

It is modelled on the phase structure of the FDA guidance on investigating OOS test results.

What's inside

• 21 chromatographic failure modes

• 158 probable causes, each with the observation that confirms or rules it out

• 167 diagnostic checks across Phase Ia, Ib and II

• 8 worksheet types, as Word or PDF

How it works

1. Symptom triage: type what you see and get the matching symptom and containment steps.
2. Engineered protocol: checks ordered cheapest and most discriminating first.
3. Investigation record: record every outcome and see which causes your evidence supports or rules out.
4. Worksheets: Phase Ia, Ib, II, hypothesis log, integration review, retest protocol, root cause & CAPA, and the Field Alert clock assessment.

Built for regulated labs: a Field Alert reminder; it never proposes testing into compliance or averaging a failure away; the conclusion stays with your analysts and QA.

Your data stays with you: investigations are saved only in your browser.

What you get: a licence key valid for 1 year, used on 2 devices, working in any modern browser with nothing to install, plus the User Guide and four additional explicative pdf documents.

Important: this is a decision-support and documentation aid, not a validated GMP record system, and it is not regulatory advice.