Question 1

What is ExcursionAssess AI?

Accepted Answer

ExcursionAssess AI is a SaaS decision-support tool for pharmaceutical companies to assess temperature excursions during storage and transportation using AI grounded in product stability data, MKT calculations, and regulatory frameworks (ICH, WHO GDP, USP).

Question 2

Does ExcursionAssess AI replace QA judgement?

Accepted Answer

No. ExcursionAssess AI is a decision-support tool. All AI assessments are reviewed and approved by qualified QA personnel via a 21 CFR Part 11 compliant workflow with electronic signatures.

Question 3

How is Mean Kinetic Temperature (MKT) calculated?

Accepted Answer

MKT is calculated according to USP <1079.2> using the Arrhenius equation. Temperatures are converted to Kelvin, the activation energy (Ea) is converted from kJ/mol to J/mol, and the result is returned in °C rounded to 2 decimals.

Question 4

Is the platform 21 CFR Part 11 compliant?

Accepted Answer

Yes. The platform implements controlled-document behaviour: after QA approval records are locked, electronic signatures and re-authentication are required, and a complete audit trail is maintained for all critical actions.

Question 5

What regulatory frameworks does ExcursionAssess AI follow?

Accepted Answer

ICH Q1A(R2), ICH Q1E, WHO GDP, USP <659>, USP <1079>, USP <1079.2>, and FDA 21 CFR Part 11 principles.

Question 6

Is my data isolated from other tenants?

Accepted Answer

Yes. The platform enforces strict multi-tenant isolation through Row-Level Security (RLS) policies. No data is ever shared across tenants.

Question 7

What does the Free plan include?

Accepted Answer

The Free plan includes 3 assessment credits and a 7-day trial with 1 user. Paid plans add more users, storage, and assessment credits.

Frequently Asked Questions

Compliance & Quality

Scientific Method

Data & Integrations

Reporting & Audits

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Frequently Asked Questions

Compliance & Quality

Is ExcursionAssess AI compliant with 21 CFR Part 11?

Does ExcursionAssess AI replace QA or QP decision making?

Which regulatory guidelines are reflected in the analysis logic?

Scientific Method

How does ExcursionAssess AI calculate Mean Kinetic Temperature (MKT)?

What stability data is required to analyze a temperature excursion?

Data & Integrations

Can I use ExcursionAssess AI with my existing temperature monitoring systems?

Reporting & Audits

How does the platform support audits and inspections?

Still have questions?