Stratogene Pharma
traceability/audit
Today
Active
4
Ready
3
Open Dev.
1
Yield 30d
95.3%
OOS 30d
0.09%
Audit Trail
Complete tamper-proof searchable activity log.
Total entries
1052
Users
7
Batches covered
61
Integrity
✅ Verified
Showing 1052 of 1052 entries
Entries
🔐 SHA-256 Audit Chain Active
1052 entries | All hashes computed at write time · Chain integrity: ✅ VERIFIED
Algorithm: SHA-256 (Web Crypto API) · Compliance: 21 CFR §11.10(e) | ALCOA+
| # | Timestamp | Shift | User | Role | Batch | Action | Details | Entry Hash |
|---|---|---|---|---|---|---|---|---|
| 1 | 2026-06-05 09:03:00 UTC | Evening | Rajesh Kumar | QA Manager | MET-0891 | E-Signature Applied | Batch MET-0891 closure authorized | … |
| 2 | 2026-06-05 09:02:00 UTC | Evening | Rajesh Kumar | QA Manager | MET-0891 | Batch Closed | Closure checklist completed for MET-0891 | … |
| 3 | 2026-06-05 08:30:00 UTC | Evening | Rajesh Kumar | QA Manager | — | CAPA Created | CAPA-MET-0891-001 created from DEV-MET-0891-002 | … |
| 4 | 2026-06-05 05:02:00 UTC | Day | Priya Sharma | QA Operator | MET-0891 | Deviation Raised | DEV-MET-0891-002 created (OPEN) | … |
| 5 | 2026-06-04 04:15:00 UTC | Day | Priya Sharma | QA Operator | MET-0891 | Check #1 Entered | Blister Seal Integrity = 100% (PASS) | … |
| 6 | 2026-06-03 03:30:00 UTC | Day | Priya Sharma | QA Operator | MET-0891 | Check #5 Entered | Fill Weight = 500.3mg (PASS) | … |
| 7 | 2026-06-02 10:30:00 UTC | Evening | Priya Sharma | QA Operator | MET-0891 | Check #1 Entered | Coating Thickness = 0.44mm (PASS) | … |
| 8 | 2026-06-02 03:30:00 UTC | Day | Priya Sharma | QA Operator | MET-0891 | Check #4 Entered | Fill Weight = 501.7mg (PASS) | … |
| 9 | 2026-06-01 08:00:00 UTC | Day | Priya Sharma | QA Operator | MET-0891 | Check #3 Entered | Fill Weight = 499.4mg (PASS) | … |
| 10 | 2026-06-01 04:50:00 UTC | Day | Priya Sharma | QA Operator | MET-0891 | Deviation Raised | MET-0891-001 created (CLOSED) | … |
| 11 | 2026-06-01 04:46:00 UTC | Day | System | Auto | MET-0891 | Hold Request Created | Auto-triggered by OOS on check #2 | … |
| 12 | 2026-06-01 04:45:00 UTC | Day | Priya Sharma | QA Operator | MET-0891 | OOS Detected | Fill Weight = 485mg (OOS) | … |
| 13 | 2026-06-01 04:15:00 UTC | Day | Priya Sharma | QA Operator | MET-0891 | Check #1 Entered | Fill Weight = 502.1mg (PASS) | … |
| 14 | 2026-06-01 02:30:00 UTC | Day | Amit Patel | Production Supervisor | MET-0891 | Batch Initiated | MET-0891 initiated on Line 1 | … |
| 15 | 2026-05-30 12:31:00 UTC | Evening | Rajesh Kumar | QA Manager | IBU-0339 | E-Signature Applied | Batch IBU-0339 closure authorized | … |
| 16 | 2026-05-30 12:30:00 UTC | Evening | Rajesh Kumar | QA Manager | IBU-0339 | Batch Closed | Closure checklist completed for IBU-0339 | … |
| 17 | 2026-05-30 01:30:00 UTC | Day | Rohan Mehta | QA Operator | IBU-0339 | Check #13 Entered | Seal Integrity = nullvisual (PASS) | … |
| 18 | 2026-05-30 01:00:00 UTC | Day | Rohan Mehta | QA Operator | IBU-0339 | Check #14 Entered | Print Verification = nullvisual (PASS) | … |
| 19 | 2026-05-30 00:30:00 UTC | Day | Rohan Mehta | QA Operator | IBU-0339 | Check #12 Entered | Seal Integrity = nullvisual (PASS) | … |
| 20 | 2026-05-29 12:31:00 UTC | Evening | Rajesh Kumar | QA Manager | MET-0890 | E-Signature Applied | Batch MET-0890 closure authorized | … |
SHA-256 chain verified · no gaps detected
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Timestamps stored in UTC per 21 CFR §11.10(e), EU GMP Annex 11, and ALCOA+ principles. Local timezone shown for readability only.