Data Analysis Software for APSD

Reliable APSD results depend on consistent calculation methods and clear reporting. Our data analysis software is purpose-built for NGI workflows, providing structured inputs, validated calculations, and streamlined output formats to simplify review.

Core Capabilities

• APSD metrics: MMAD, GSD, FPF, stage groupings, and mass balance checks.
• Method templates: Standardize calculations and outputs across methods and products.
• Batch analysis: Process multiple runs at once to increase throughput.
• Reporting: Generate review-ready PDFs and export data to LIMS or CSV for downstream systems.

Data Integrity Features

• User roles and permissions: Assign access based on function and responsibility.
• Audit trail: Track changes to critical parameters and data entries.
• Electronic signatures: Support review and approval workflows when configured in a validated, 21 CFR Part 11–aligned environment.
• Version control: Maintain control over method templates and software revisions.

Workflow Benefits

• Faster review: Unified calculations and standardized outputs reduce manual checking.
• Reduced variability: Minimize spreadsheet drift and version inconsistencies.
• Easier method transfer: Use shared templates to align sites and streamline training.
• Scalable deployment: Configure for development teams, QC labs, or global networks.

Standards Awareness

The software is designed to support pharmacopeial APSD methods (for example, USP <601>, Ph. Eur. 2.9.18) with transparent, documented calculation logic. Clear reports and export options help create defensible data sets for submissions and audits.

With purpose-built APSD software, teams can spend less time on manual calculations and more time interpreting results and advancing products.