Total Systems
248
↑ 12 new systems this quarter
Validated Systems
227
↑ 91.5% compliance rate
In Progress
15
On track for completion
Overdue Validations
6
↓ Reduced from 9 last month
Avg. Validation Time
47
↓ Days (Target: 60)
Upcoming Revalidations
23
Next 90 days
Validation Status by GAMP Category 21 CFR Part 11
GAMP Category Total Validated In Progress Compliance %
Category 3 87 85 2 97.7%
Category 4 132 119 10 90.2%
Category 5 29 23 3 79.3%
Critical System Risk Assessment ISO 14971
Low
45 systems
Low
38 systems
Medium
27 systems
Medium
19 systems
High
8 systems
⚠️ Action Required: 8 high-risk systems require enhanced monitoring and quarterly reviews per GAMP 5 guidance.
Active Validation Projects – Current Quarter URS → FRS → IQ/OQ/PQ
System Name GAMP Cat. Current Phase Progress Owner Target Date Status
LIMS System Upgrade v4.2 Cat 4 OQ Execution
65%
 J. Martinez Dec 15, 2025 In Progress
Manufacturing Execution System (MES) Cat 5 IQ Complete, OQ Planning
40%
 R. Chen Jan 30, 2026 In Progress
Temperature Monitoring System – Warehouse B Cat 4 PQ Execution
85%
 M. Thompson Dec 5, 2025 In Progress
ERP System – Quality Module Update Cat 4 URS Review
15%
 S. Patel Feb 28, 2026 Planning
Electronic Batch Record System Cat 5 Vendor Assessment
20%
 A. Williams Apr 15, 2026 Planning

Validation Lifecycle Management

Validation Deliverables Completeness GAMP 5
URS Documents ✅ 100%
FRS Documents ✅ 98%
Risk Assessments ✅ 100%
IQ Protocols ✅ 96%
OQ Protocols ⚠️ 89%
PQ Protocols ✅ 92%
Validation Reports ✅ 94%
Traceability Matrix ✅ 100%
Upcoming Revalidation Schedule (90 Days) Periodic Review
System Last Validation Due Date Days Until Due Priority
HPLC System – QC Lab 2 Nov 28, 2022 Nov 28, 2025 3 days Critical
Building Automation System Dec 15, 2022 Dec 15, 2025 20 days High
Cleaning Validation – Line 3 Jan 10, 2023 Jan 10, 2026 46 days Medium
Water System Monitoring Feb 01, 2023 Feb 01, 2026 68 days Medium
Stability Chamber – Room 405 Feb 20, 2023 Feb 20, 2026 87 days Low
Validation Cycle Time Trends Efficiency Metrics
Quarter Projects Completed Avg. Cycle Time (Days) On-Time Completion % Resource Hours Trend
Q1 2025 18 52 83% 2,340 📊
Q2 2025 22 49 86% 2,580 📈
Q3 2025 20 47 90% 2,420 📈
Q4 2025 (Current) 15 (In Progress) 45 (Projected) 93% (Target) 1,950 (YTD) 🎯

Regulatory Compliance Dashboard

21 CFR Part 11 Compliance
98.4%
✓ Audit Trail Compliant
EU Annex 11 Compliance
97.2%
✓ All Critical Systems
ALCOA+ Data Integrity
99.1%
↑ Improved from 97.8%
Open FDA Observations
2
CAPA in progress
21 CFR Part 11 Compliance Status Electronic Records & Signatures
§11.10 Controls ✅ Pass
§11.50 Signatures ✅ Pass
§11.100 Records ✅ Pass
§11.200 E-Signatures ✅ Pass
§11.300 Controls ✅ Pass
Audit Trail Review ✅ Current
✓ Compliance Status: All computerized systems meet 21 CFR Part 11 requirements. Last audit: Sep 2025.
ALCOA+ Data Integrity Monitoring FDA Guidance
Principle Systems Monitored Compliance Rate Incidents (30d)
Attributable 248 99.6% 1
Legible 248 100% 0
Contemporaneous 248 99.2% 2
Original 248 99.6% 1
Accurate 248 98.8% 3
+ Complete 248 99.2% 2
+ Consistent 248 99.6% 1
+ Enduring 248 100% 0
+ Available 248 99.6% 1
Vendor Qualification & Certificate Tracking ISO 13485 / ISO 9001
Vendor Name Systems Supported ISO 13485 ISO 9001 Last Audit Next Audit Status
LabWare Inc. LIMS, QC Data ✅ Valid until 2026 ✅ Valid until 2026 Mar 2024 Mar 2026 Qualified
Rockwell Automation MES, SCADA N/A ✅ Valid until 2025 Jun 2024 Jun 2026 Qualified
TrackWise Digital QMS, CAPA ✅ Valid until 2027 ✅ Valid until 2027 Sep 2023 Sep 2025 Qualified
Vaisala Env. Monitoring ✅ Valid until 2026 ✅ Valid until 2026 Jan 2024 Dec 2025 Audit Due
SAP SE ERP, QM Module N/A ✅ Valid until 2026 Aug 2023 Aug 2025 Audit Overdue
Training & Competency Matrix – Validation Team 21 CFR Part 211
Team Member GAMP 5 21 CFR Part 11 ISO 13485 Data Integrity Last Assessment Status
Martinez, J. ✅ Current ✅ Current ✅ Current ✅ Current Oct 2025 Qualified
Chen, R. ✅ Current ✅ Current ⚠️ Expires Dec 2025 ✅ Current Sep 2025 Renewal Due
Thompson, M. ✅ Current ✅ Current ✅ Current ✅ Current Nov 2025 Qualified
Patel, S. ✅ Current ⚠️ Expires Jan 2026 ✅ Current ✅ Current Aug 2025 Qualified
Williams, A. ✅ Current ✅ Current ✅ Current ✅ Current Oct 2025 Qualified

Quality Events & CAPA Management

Open Deviations
14
↓ Down from 19
Active CAPAs
23
87% on track
Overdue CAPAs
3
↓ Reduced by 60%
Change Controls
31
8 validation impacts
Validation-Related Deviations – Last 6 Months Trend Analysis
Month Total Deviations Critical Major Minor Avg. Closure Time
Jun 2025 8 1 3 4 18 days
Jul 2025 6 0 2 4 15 days
Aug 2025 9 2 4 3 22 days
Sep 2025 5 0 2 3 14 days
Oct 2025 4 1 1 2 12 days
Nov 2025 3 0 1 2 10 days
📉 Positive Trend: 62% reduction in deviations over 6 months. Enhanced training and process improvements showing measurable impact.
CAPA Effectiveness Tracking Continuous Improvement
CAPA ID Root Cause System Initiated Target Close Status
CAPA-2025-087 Inadequate test coverage LIMS v4.2 Sep 15, 2025 Dec 15, 2025 In Progress
CAPA-2025-092 Missing URS requirement MES System Oct 3, 2025 Jan 3, 2026 In Progress
CAPA-2025-098 Audit trail gap ERP QM Module Oct 20, 2025 Nov 20, 2025 5 Days Overdue
CAPA-2025-104 Incomplete traceability Temp Monitor Nov 1, 2025 Feb 1, 2026 Planning
CAPA-2025-108 Training gap Multiple Systems Nov 10, 2025 Dec 10, 2025 In Progress
Change Control Impact on Validated Systems Revalidation Triggers
Change Control # System Affected Change Type Validation Impact Revalidation Required Status
CC-2025-234 LIMS System Software Patch 4.2.1 Minor – OQ only Partial (20 tests) Complete
CC-2025-241 MES System Hardware Upgrade Major – IQ/OQ/PQ Full Revalidation In Progress
CC-2025-248 Building Auto Config Change Low – Documentation Document Update Only Complete
CC-2025-253 ERP System Module Addition Major – Full Suite New Module Validation Planning
CC-2025-257 Temp Monitor Sensor Replacement Minor – PQ only Performance Verification In Progress
Root Cause Analysis – Validation Failures YTD 2025
Root Cause Category Occurrences % of Total Mitigation Status
Incomplete Requirements (URS/FRS) 12 34% Training Enhanced
Inadequate Test Coverage 8 23% Process Updated
Vendor Documentation Gaps 6 17% Audit Program Enhanced
Traceability Issues 5 14% Template Revised
Training Deficiencies 4 11% Program Completed
Audit Findings – Internal & External Last 12 Months
Audit Type Date Critical Major Minor Closure Rate
Internal QA Audit Jan 2025 0 2 5 100%
Vendor Audit – LabWare Mar 2025 0 1 3 100%
Mock FDA Inspection Jun 2025 0 3 8 100%
Internal QA Audit Sep 2025 0 1 4 100%
FDA Inspection Oct 2025 0 2 3 60% (In Progress)
⚠️ FDA 483 Response: 2 major observations related to periodic review documentation and change control procedure. CAPA-2025-112 & CAPA-2025-113 initiated. Target closure: Jan 31, 2026.