Plan & rehearse
- A calendar for internal, regulatory, and customer visits
- Mock audits before the real day
- Findings with clear ownership and signatures
- Follow-up into quality work when QMS is licensed
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Real-Time Compliance Gap Engine & Inspection Room Mode
Regulatory inspections should never trigger panic, scrambling, or late-night binder assembly. Novaqis AuditLens continuously monitors data across DMS, LIMS, LMS, QMS, and BRM to catch compliance gaps in real time, manages your complete audit calendar, and projects an interactive live Inspection Room Mode with one-click cryptographic evidence exports.
Intelligence / Dashboard
Pre-inspection readiness
Scope: AUDITLENS · DMS · LMS · QMS · BRM
Executive status
ACTION REQUIRED
Open audits
4
2 FDA · 1 Internal
Open findings
12
3 critical
Anomalies
7
Cross-module
Trace coverage
94%
Licensed modules
Entity trace - SOP-QA-0142
Live leaf callsSOP-QA-0142 v3.0 Effective
Published · training gate on
12 / 14 qualified readers
2 overdue retrainings
CAPA-2026-0088 linked
Root cause closed
Referenced in BCH-2026-0142
Issuance token verified
Anomaly findings
Effective SOP without training
[LMS] Close overdue assignments
CAPA closed without doc revision
[DMS] Open change control
Operator qual gap on Line 03
[BRM] Hold step until LMS gate
At a glance
Enterprise Architecture
Deterministic architectures and automated compliance engines engineered for multi-plant pharma operations.
AuditLens acts as a continuous 24/7 compliance sentinel across all modules, automatically detecting orphaned quality events, missing witness sign-offs, out-of-sequence timestamps, unreviewed audit trails, or overdue training interlocks in real time.
Register, schedule, assign, and track all internal site audits, supplier/vendor assessments, customer quality audits, and regulatory inspections (US FDA, CDSCO, WHO, MHRA) on an interactive timeline with automated milestone reminders and checklists.
Single-pane-of-glass interface designed specifically for active regulatory walkthroughs. Present clean, tamper-proof record histories and batch genealogies in seconds without hopping between disparate software applications or exposing confidential data.
Instantly follow the full compliance thread: start from an SOP revision, view the operator's reading dwell-time qualification, verify the QC analytical CoA, inspect the batch execution step, and review linked deviations without manual cross-referencing.
Automated background auditing enforces Attributable, Legible, Contemporaneous, Original, and Accurate standards across all electronic records, eliminating 483 warning letter findings before external visitors step on site.
Generate comprehensive, time-stamped, and digitally sealed PDF evidence packages during active audit sessions, eliminating manual photocopying and binder assembly.
Conduct realistic mock inspection drills with internal auditors, capture findings under 21 CFR Part 11 electronic signatures, and automatically route follow-up CAPAs directly into Novaqis QMS.
Runs securely inside your validated private cloud or local plant network with complete data sovereignty and zero external telemetry.
In the product
From entity trees and anomaly scans to e-signed findings and Nova AI compliance queries - everything stays license-scoped and on the same ALCOA+ fabric as Admin, DMS, LMS, QMS, and BRM.
Trace
Cross-module entity trees
Scan
Anomaly detection
Ready
Executive audit status
Scoped
License + RBAC only
Pre-inspection readiness
Intelligence / Dashboard
Pre-inspection readiness
Scope: AUDITLENS · DMS · LMS · QMS · BRM
Executive status
ACTION REQUIRED
Open audits
4
2 FDA · 1 Internal
Open findings
12
3 critical
Anomalies
7
Cross-module
Trace coverage
94%
Licensed modules
Entity trace - SOP-QA-0142
Live leaf callsSOP-QA-0142 v3.0 Effective
Published · training gate on
12 / 14 qualified readers
2 overdue retrainings
CAPA-2026-0088 linked
Root cause closed
Referenced in BCH-2026-0142
Issuance token verified
Anomaly findings
Effective SOP without training
[LMS] Close overdue assignments
CAPA closed without doc revision
[DMS] Open change control
Operator qual gap on Line 03
[BRM] Hold step until LMS gate
Cross-system entity trees
Traceability / Entity trace
Cross-system entity tree
Traceability · live leaf calls
Controlled document lineage
No invented rows outside licenseSOP-QA-0142 v3.0 Effective
Published · training gate on
12 / 14 qualified readers
2 overdue retrainings
CAPA-2026-0088 linked
Root cause closed
Referenced in BCH-2026-0142
Issuance token verified
Snapshot saved for inspection pack
ALCOA+ sealed
Severity-coded findings
Intelligence / Anomalies
Severity-coded findings
Intelligence · department-scoped
Executive status
HIGH RISK
Critical
2
Major
3
Minor
2
Effective SOP without training completion
[LMS] Close overdue assignments for QA readers
Batch step executed without current qualification
[BRM] Hold Line 03 until LMS gate clears
CAPA closed without controlled-document revision
[DMS] Open change control for SOP-QA-0142
Open deviation older than SLA window
[QMS] Escalate owner and refresh risk assessment
Superview drift: LMS curriculum vs DMS effective set
[AUDITLENS] Re-run LMS superview after sync
Compliance queries for auditors
Intelligence / Nova AI
Compliance queries for auditors
Inspection context
Nova AI · AuditLens tools
Deterministic trace · readiness · anomalies
Capability depth
Plan audits, rehearse before the visit, and see how documents, training, quality, and batches connect across the Novaqis modules you license, without overnight spreadsheet archaeology.
Inspection readiness
Audit prep often means exporting from every system into binders. AuditLens helps you plan, rehearse, and see connections across the Novaqis modules you license.
Manual joins across exports and email.
Follow a record across what you license.
What to try in a pilot
+2 more evaluation items in the full comparison - expand above.
Last-minute hunts in each system.
Early views and leadership-friendly status.
What to try in a pilot
+2 more evaluation items in the full comparison - expand above.
Shared folders and unsigned finding logs.
Calendar, mock audits, signed findings.
What to try in a pilot
+2 more evaluation items in the full comparison - expand above.
Categories describe common market patterns, not any specific vendor. Your inspection scope and licensed modules decide fit.
Regulatory alignment
Technical Research
Talk to our team about how Novaqis AuditLens fits your validation and compliance requirements.
FAQ