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StatSoft pharmaceutical applications

by StatSoft Polska
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Quality AnalyticsQuality Analytics

A family of pharmaceutical statistical applications for quality monitoring, process and method validation, dissolution comparison, stability, environmental monitoring and measurement uncertainty.

This profile groups PQM, PV, DPC, AMV, PS, EM and MU. Each serves a different analytical task. Current commercial packaging is unconfirmed, so the grouping does not mean that one licence includes all applications. PLCS is a separate database product.

PQM and PV support process quality and validation statistics. DPC compares dissolution profiles. AMV analyses method-validation data. PS evaluates stability and shelf life. EM analyses environmental results. MU calculates measurement uncertainty. Optional databases are described for several applications.

Several desktop pages claim cGxP validation. AMV claims cGMP validation; MU practice coverage is unconfirmed. Paid DPC SaaS includes validation documentation and a certificate. Those statements do not establish shared controls or a validated customer environment across this family.

Adamed Pharma S.A. gives a vendor-hosted testimonial for Statistica and dedicated validation, stability and dissolution applications. Exact current modules and versions are unconfirmed.

Key Features & Capabilities

Core Capabilities

PQM Product Quality Monitoring: quality review and routine process monitoring, capability and control charts, outlier checks and report generation.
PV Process Validation: batch homogeneity, capability, equivalence and out-of-specification probability analysis.
DPC Dissolution Profiles Comparison: statistical comparison of dissolution curves, including similarity factors, bootstrap methods and model comparisons.
AMV Analytical Method Validation: precision, accuracy, calibration, range and method-transfer analysis; the vendor names ICH Q2(R2).
PS Product Stability: shelf-life estimates, batch pooling, accelerated-study analysis and trends; the published example names ICH Q1E.
EM Environmental Monitoring: environmental and microbiological statistics, limits, rare events and organism summaries.
MU Measurement Uncertainty: combine uncertainty components, prepare budgets and analyse calibration.
Saved study settings and analytical reports. Output and optional database scope vary by application.
DPC SaaS: browser-based dissolution analysis; paid subscription adds Word output, templates and validation materials.
Technical Specifications

Desktop add-ins inside Statistica are documented in a customer-side installation guide for the 2024–2025 licence period. Current runtime versions, required Statistica edition and separate licence fees are unknown. DPC and AMV pages describe Excel or Statistica data inputs; this does not establish a common API or connector set.

DPC SaaS runs in a browser on Microsoft Azure, according to the vendor. The public login warns that its interface is not adapted for mobile use. Cloud regions, APIs, single sign-on, multi-factor authentication, recovery targets and scale limits are unknown. Azure hosting applies only to DPC SaaS in this profile.

Pricing Information

Desktop licence types, user limits, bundle prices, database charges and Statistica dependencies are unknown.

DPC SaaS advertises a 30-day trial. Paid subscription adds unwatermarked reports, Word output, templates, validation documentation and a certificate. Registration initially permits one administrator; additional users require a commercial upgrade. Public currency prices are unconfirmed. These terms apply to DPC SaaS only.

The public DPC cloud agreement limits use to employees and restricts external result sharing except with the regulator. It allows feature changes without prior notice and provider-selected hosting. Basic support is discretionary. It permits discontinuation on 30 days’ notice and data deletion at termination. A separately negotiated agreement can take precedence. Confirm current written terms for contractors, change control, retention and exit.

Implementation Details

StatSoft offers pharmaceutical analytical consulting and implementation support. Included licence services, delivery timelines, database migration and acceptance procedures are unknown.

Define the intended analyses, report templates, runtime and database options before purchase. Request tests for the actual source-to-report path and saved analysis settings. These are buyer checks, not reports of calculation defects.

Strengths & Limitations

PharmaSpotter assessment from published vendor and third-party sources. No user reviews are on file for this product.

Strengths

Independent current product-review themes are unknown.

Limitations & Open Questions

Independent current product-review complaints are unknown.

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Notable Customers

Publicly disclosed pharmaceutical and biotech organizations

Adamed Pharma S.A.
Vendor Information
StatSoft Polska logo

StatSoft Polska

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Kraków, Małopolskie, Poland
Founded 1995 (31 years)
1001-5000 employees
Subsidiary
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