Welcome back, Raushan
Sunday, 10 May 2026 · 3 batches assigned
Active Batches
12
↑ 3vs last week
LabWare Events Today
247
LWsync 12s ago
OOS This Month
1open
DEV-014investigation
Batches Near Expiry
2batches
M22025· M22023
Test results flow from LabWare 8, QMS runs the quality workflows. Click any record to drill into facts.
Active Batches
Click any row to open batch detail
| Batch | Product | Mfg | Expiry | Tests | Status |
|---|
Batches
All batches synced from LabWare 8 · expiry tracking enabled
| Batch No. | Product | Mfg Date | Exp Date | Batch Size | Tests | Status |
|---|
Batch M22031
Formoterol Fumarate + Budesonide MDI · 6+200 mcg
✓ Stage 1 · Prepared
Analyst
Raushan Prasad
14 MAY · 11:08
✓ Stage 2 · Checked
Reviewer
Ganesh Salve
14 MAY · 14:22
✓ Stage 3 · Approved
QA Manager
Vijay Patel
14 MAY · 16:55
Batch Information
Test Results from LabWare 8
Read-only · click any result to view raw data in LabWare
| Test | Specification | Result | Status | Source |
|---|
Deviations & OOS
Auto-opened from LabWare OOS events · investigated in QMS
| ID | Source | Batch | Test | Result | Severity | Status |
|---|
Deviation DEV-2026-014
Out-of-Specification: Atorvastatin Assay
OOS auto-detected from LabWare · Test result LW-TR-2801 failed specification. Batch M22028 placed on hold.
Failure Details
Test
Assay — Atorvastatin (HPLC)
Specification
98.0 — 102.0 %
Observed Result
89.4 %
Deviation
-8.6 % below limit
LabWare Reference
Instrument
HPLC ML_QC_080
Analyst
Priya Menon
Detected At
09 May 2026, 16:30 IST
Affected Batch
Batch No.
M22028
Product
Atorvastatin 10mg Tablets
Batch Size
100,000 tablets
Mfg Date
04/2026
Expiry
03/2029
Current Status
Hold — Investigation
Investigation Timeline
OOS detected from LabWare
Webhook received, deviation auto-created
QA Manager notified
Batch placed on Hold
Phase 1A Lab Investigation
Re-injection scheduled · system suitability re-verified
Phase 1B Manufacturing Review
Root Cause Identification
CAPA Linking
QA Closure Approval
CAPA
Corrective and Preventive Actions
| ID | Title | Type | Source | Owner | Due | Status |
|---|
CAPA CAPA-2026-018
Atorvastatin HPLC method robustness improvement
CAPA Details
Type
Corrective + Preventive
Linked Deviation
Owner
Vijay Patel
Due Date
25 May 2026
Root Cause
Method robustness — mobile phase pH variation
Status
In Progress
Action Items
| Action | Owner | Status |
|---|---|---|
| Revise mobile phase preparation SOP | Vijay P. | Done |
| Re-validate HPLC method per ICH Q2(R1) | Ganesh S. | In Progress |
| Re-train all QC analysts on revised method | Raushan P. | Not Started |
Progress Timeline
CAPA Initiated
Plan Approved
Implementation
Completion
Effectiveness Check
Incidents
Minor anomalies and near-misses
| ID | Title | Area | Severity | Reporter | Date | Status |
|---|
Incident INC-2026-008
HPLC System Suitability Failure — ML_QC_080
Incident Details
Reporter
Raushan Prasad
Area
QC Laboratory
Severity
Medium
Source
LabWare auto-event
Equipment
HPLC ML_QC_080
Reported At
10 May 2026, 10:14 IST
Description: System suitability check failed for the morning HPLC run. Theoretical plates dropped to 1,850 (spec ≥2,000). Re-injection after column flush brought values back to 7,088. No batch impact since this was pre-run SST. Column maintenance scheduled.
Change Control
Formal control over process, equipment, material, method changes
| ID | Title | Type | Category | Initiator | Status |
|---|
Change Control CC-2026-022
Budesonide vendor qualification expansion
Change Details
Type
Material — Vendor Addition
Category
Minor
Initiator
Vijay Patel
Status
Impact Assessment
Justification: Add Aarti Industries (VC009) as secondary qualified vendor for Budesonide BP to reduce single-source supply risk currently with Vamsi Labs.
Market Complaints
Customer complaints with batch traceability
| ID | Product | Batch | Customer | Severity | Received | Status |
|---|
Complaint CMP-2026-003
Customer reports inconsistent dose count in Salbutamol MDI
Complaint Details
Customer
Cipla Ltd.
Product
Salbutamol Sulphate MDI 100 mcg
Batch
Severity
Quality
Source
Distributor
Received
02 May 2026
Complaint: Customer reports 3 units from Batch M22030 showed metered dose count of 188-192, below the labeled 200 doses. Retain samples being tested.
Recall
Statutory and voluntary recalls
No active recalls
Recall workflow activates from Critical Complaint or QA decision. Includes scope determination, customer notification, destruction tracking, regulatory submission.
Materials Catalog
Synced from LabWare 8 every 15 minutes
Materials are master-managed in LabWare 8. To add a new material, raise a Change Control.
| Code | Material | Type | Specs | Last LW Sync |
|---|
Approved Vendors
Annexure QA/018-A6 v07
| Code | Vendor | Location | Materials | Status |
|---|
Certificates of Analysis
Generated from LabWare test data + QMS signatures
| CoA | Batch | Product | Customer | Issued | Status |
|---|
Auditor Observations
Inspector observations and QA responses
Integrations
External systems feeding data into QMS
LW
LabWare LIMS v8 Connected
Source of truth for analytical test data. Provides materials, specs, test results, batch state, OOS events via REST + webhooks.
Last Sync
12s ago
Events Today
247
LabWare Event Stream · Last Hour
| Time | Event | LabWare Reference | QMS Action |
|---|---|---|---|
| 10:42 | TestResultEntered | LW-TR-3047 | Updated M22031 progress |
| 10:30 | OOS_Detected | LW-TR-2801 | DEV-2026-014 created |
| 10:22 | BatchReleased | LW-BATCH-22030 | CoA generation triggered |
| 10:14 | SystemSuitabilityFailed | LW-SST-441 | INC-2026-008 created |
| 10:05 | MaterialMasterUpdated | LW-MAT-Budesonide | CC-2026-022 drafted |
Audit Trail
Immutable event log · 21 CFR §11.10(e)
| Time | Action | Entity | Detail | User |
|---|---|---|---|---|
| 10:42 | LW SYNC | LW-TR-3047 | Microbial result from LabWare | system |
| 10:30 | OOS | M22028 | OOS · DEV-2026-014 created | system |
| YESTERDAY 16:55 | APPROVE | M22031 | Final release approved · CoA FPT/22046 | vijay.p |
| YESTERDAY 14:22 | SIGN | ESIG 7281-B | Stage 2 (Checked) signed | ganesh.s |
| YESTERDAY 11:08 | SIGN | ESIG 7281-A | Stage 1 (Prepared) signed | raushan.p |