SyntriqAutomate evidence assembly.
Defend your root cause analysis.
Upload your sensor logs, batch records, SOPs, and shift logs. Syntriq extracts events from every document, reconstructs a chronological timeline, flags SOP violations, and helps your team build a defensible root cause analysis and investigation report — all with direct links back to the source evidence.
The Impact on Quality Operations
70% Reduction
In data collection and cross-referencing lag time, removing the primary bottleneck to the 30-day target closure window.
Source-Linked
Every finding links directly to the original uploaded document, so your team can verify any claim in seconds.
Enterprise Security
Role-based access, encrypted storage, and activity tracking designed for regulated manufacturing environments.
How it works
From scattered evidence to defensible investigation report.
Five steps. One workspace. Every finding traced back to its source document.
Upload evidence
Drop in every document related to the deviation — sensor CSVs, batch records, SOPs, cleanroom logs, training matrices, QA forms. All file types, one workspace.
Automated timeline & SOP analysis
Syntriq reads every document, extracts dated events, and reconstructs a chronological timeline. It cross-references your SOPs to flag violations, calculates derived metrics like excursion duration, and identifies systemic failures — all with source citations you can click to verify.
08:45 — Particle excursion detected
≥0.5 µm count exceeded alert limit · Particle_Counter_PC-FA03.csv
SOP-EM-002 §3.3c — Violation (Major)
Shift Supervisor not notified within 15 min · SOP-EM-002.txt
Derived — Excursion duration: 3h 0min
Computed from sensor data · Particle_Counter_PC-FA03.csv
11:45 — Particle counts return to normal
All readings within specification · Particle_Counter_PC-FA03.csv
Root cause analysis
Contributing factors are auto-extracted from the timeline and organized into a 6M Fishbone. Click any factor to see the evidence evaluation — what supports it, what the SOP requires, and whether it holds up. Drill deeper with 5 Whys, each level backed by document citations.
Method
3 factors
Machine
2 factors
Environment
2 factors
Man
1 factor
Measurement
1 factor
Material
0 factors
Each level suggests answers from your evidence with clickable source links
AI investigation assistant
Ask questions directly about your uploaded evidence. The assistant reads all documents and responds with source-cited answers — no hallucination, no generic pharma knowledge. Just your data.
“What was K. Tanaka's gowning assessment score?”
K. Tanaka received a marginal gowning assessment during her first supervised session, scoring 72% against a minimum threshold of 80%.
Source: Operator_Training_Matrix.csv
“Were there any interventions during the excursion window?”
Two aseptic interventions occurred: a dropped stopper tray at 09:15 and a torn glove discovered at 10:15, both by K. Tanaka.
Source: Aseptic_Intervention_Logs_AIL-2025-0421.txt
Draft investigation report
Build your investigation report in the built-in editor. The AI assistant can generate sections — event description, impact assessment, root cause summary — and you edit, refine, and approve. Export to Word when ready.
Syntriq is the drafting tool. Your QMS is the system of record. When the report is ready, export it and submit through your existing quality workflow.
Event Description
Impact Assessment
Root Cause Summary
Platform Capabilities
Engineered to handle the complexity of bio-pharmaceutical deviations.
Multi-Stream Data Syncing
Upload raw CSV historian logs, MES exports, and batch records simultaneously. Syntriq aligns out-of-spec physical excursions with operational logs automatically.
Automated SOP Spec Matching
The engine parses location and asset-specific SOP documentation, mapping multi-variable limits directly against localized time-series data to flag accurate variations.
One-Click Source Evidence Mapping
Every line item inside the investigative timeline remains hyperlinked to its raw file source. Defend decisions instantly during high-stakes internal or regulatory review panels.
Assisted Root Cause Diagnostics
Pre-populate technical context into structured 5 Whys and Fishbone (Ishikawa) methodologies, ensuring that physical process deviations are logically driven by empirical plant floor metrics.
QMS Report Structuring
Draft comprehensive event descriptions, direct process impact evaluations, and cross-referenced summaries ready to be exported safely into you QMS.
Activity Logging
Tracks who did what and when across every investigation, giving your team full transparency into the analysis process.
Operational Architecture
The intelligent engine missing from your technical stack.
Legacy QMS configurations are critical systems of record designed to store finalized documentation. Syntriq works *upstream* of the QMS—transforming unorganized manufacturing evidence into defensible findings before the final submission file is locked.
Primary Evidence Sources
SCADA Historians, LIMS assays, distributed floor monitoring hardware, shift logs, equipment maintenance logs, and active site training credentials.
Syntriq Processing Environment
Secure multi-variable data processing workspace. Parses complex process limits, isolates anomaly events, constructs linear histories, and structures compliance drafts.
The Quality Management System
QMS receives clean, defensible, human-verified technical documentation, initiating formalized CAPA sign-off procedures.
Early Cohort Request
Partner with us on a tailored site pilot deployment.
We are introducing Syntriq selectively to validation-forward sterile manufacturing and bioprocessing sites. Secure a technical demonstration modeled around your own custom deviation types.
✓ Custom operational assessments
✓ Zero disruption to active validated parameters
✓ Designed for regulated manufacturing environments