SPECTRA’s reporting module bridges the gap between statistical analysis and regulatory-ready documentation. The workflow has three stages:
As you work through the analysis modules (batch profiling, process charts, PCA, PLS, capability analysis), each chart has a “Add to Report” action. Selected graphs are queued with their derived statistics — control limits, violation counts, PCA loadings, and capability indices.
For each selected graph, SPECTRA feeds the derived statistics into an LLM that generates a plain-language analytical summary. For example, a process parameter analysis chart might produce:
“The parameter pH showed 4 violations across 12 batches analyzed at ±3σ, affecting 2 unique batches (16.7% violation rate). All violations were UCL breaches classified as major. Batch B-0042 had the worst deviation at +4.2σ above centerline.”
The analyst then reviews each AI-generated summary and can:
This workflow ensures AI assists but never replaces human judgment.
The final report is generated as a Word document containing:
The document uses Word-native heading styles, so the table of contents resolves automatically in Microsoft Word or Google Docs.
Word and PDF outputs match standard GMP documentation formats, so teams use them directly for review, approval, and archiving. Word supports collaboration and editing, while PDF provides a fixed, audit-ready version. This removes manual reformatting and speeds up validation and inspection workflows.
The report includes only the statistics and parameters you selected — no raw data is dumped into the document. Each insight section records: