Audit Evidence Packet — 21 CFR Part 11
FacilityMeridian BioSciences — Manufacturing Unit 4
Address200 Sidney Street, Cambridge, MA 02139
Audit period1 January 2026 – 31 March 2026 (Q1)
QA contactSarah Chen, QA Manager · s.chen@[redacted]
Export date2026-04-01 09:00:00 UTC
SystemAssetOS 3.2.1
Total records142 (4 assets · 4 calibrations · 5 work orders · 15 audit entries · 2 deletions · 6 users)
§ 1
4 assetsAsset Register Extract
| Asset ID | Name | Location | Criticality | Last PM | Next PM due |
|---|---|---|---|---|---|
| AST-0041 | Mettler Toledo XS205 Analytical Balance | Lab A — Rm 204 | CRITICAL | 14 Jan 2026 | 14 Apr 2026 |
| AST-0067 | Thermo Fisher 1300 Series A2 Biosafety Cabinet | Lab B — Rm 218 | CRITICAL | 22 Jan 2026 | 22 Jul 2026 |
| AST-0089 | Getinge GE 4610 Autoclave (Series 3) | Sterilization — Rm 112A | CRITICAL | 5 Jan 2026 | 5 Jul 2026 |
| AST-0112 | Agilent 1260 Infinity II HPLC System | QC Lab — Rm 301 | CRITICAL | 19 Feb 2026 | 19 Aug 2026 |
§ 2
4 recordsCalibration Records
| Cal ref | Asset | Date | Technician | Result | Approved by | Approved at |
|---|---|---|---|---|---|---|
| CAL-2026-041-01 | AST-0041 | 14 Jan 2026 | j.riley | PASS | t.bach | 14 Jan 2026 15:02 |
| CAL-2026-067-01 | AST-0067 | 22 Jan 2026 | p.nair | PASS | t.bach | 22 Jan 2026 16:44 |
| CAL-2026-089-01 | AST-0089 | 8 Feb 2026 | j.riley | PASS | s.chen | 8 Feb 2026 11:30 |
| CAL-2026-112-01 | AST-0112 | 19 Feb 2026 | p.nair | PASS | s.chen | 19 Feb 2026 14:55 |
4 of 4 calibrations passed. Next due: AST-0041 — 14 Apr 2026.
§ 3
5 work ordersWork Order History
| WO ref | Asset | Type | Description | Opened | Closed | Tech | Approved by | Status |
|---|---|---|---|---|---|---|---|---|
| WO-2026-0089 | AST-0089 | PREVENTIVE | Annual PM — gasket replacement, door seal inspection, cycle validation | 3 Jan 2026 | 5 Jan 2026 | j.riley | t.bach | APPROVED |
| WO-2026-0091 | AST-0041 | CALIBRATION | Q1 calibration — 5-point linearity check per SOP-QC-014 | 12 Jan 2026 | 14 Jan 2026 | p.nair | t.bach | APPROVED |
| WO-2026-0094 | AST-0067 | PREVENTIVE | Semi-annual certification — airflow test, HEPA integrity, UV lamp check | 19 Jan 2026 | 22 Jan 2026 | j.riley | t.bach | APPROVED |
| WO-2026-0097 | AST-0089 | CORRECTIVE | Unscheduled — chamber door pressure seal degraded. Replaced per SOP-MAINT-022. | 2 Feb 2026 | 2 Feb 2026 | j.riley | t.bach | APPROVED |
| WO-2026-0103 | AST-0112 | PREVENTIVE | HPLC column swap + post-swap system suitability qualification | 17 Feb 2026 | 19 Feb 2026 | p.nair | s.chen | APPROVED |
§ 4
15 entries (sample)Audit Trail Extract
Every field change, status transition, file upload, and sign-off is logged server-side. Log entries are immutable — they cannot be edited or removed by any user including administrators.
2026-01-05 09:14:22 UTCj.rileyWO-2026-0089 status IN_PROGRESS → COMPLETE
2026-01-05 09:14:23 UTCj.rileyWO-2026-0089 completion_notes [null] → "PM complete. Gasket set replaced (Part #GK-4610-09). All checks within spec."
2026-01-05 09:41:07 UTCt.bachWO-2026-0089 status COMPLETE → APPROVED (supervisor sign-off)
2026-01-14 14:33:18 UTCp.nairCAL-2026-041-01 result [null] → PASS (observed: 0.00003 g, tolerance: ±0.0001 g)
2026-01-14 14:33:18 UTCp.nairCAL-2026-041-01 status IN_PROGRESS → COMPLETE
2026-01-14 15:02:44 UTCt.bachCAL-2026-041-01 status COMPLETE → APPROVED (QA sign-off)
2026-02-02 07:58:04 UTCj.rileyWO-2026-0097 created type=CORRECTIVE asset=AST-0089 priority=HIGH
2026-02-02 08:11:39 UTCj.rileyWO-2026-0097 evidence_photo uploaded "door_seal_pre_replacement_20260202.jpg" (1.8 MB)
2026-02-02 08:44:12 UTCj.rileyWO-2026-0097 status IN_PROGRESS → COMPLETE
2026-02-08 10:22:11 UTCj.rileyAST-0089 location "Sterilization Rm 112" → "Sterilization Rm 112A"
2026-02-08 10:22:12 UTCj.rileyAST-0089 change_reason "Facility room renumbering per Facilities Notice FN-2026-003"
2026-02-19 14:55:01 UTCs.chenCAL-2026-112-01 status COMPLETE → APPROVED (QA sign-off)
2026-03-15 16:44:02 UTCp.nairWO-2026-0103 evidence_photo uploaded "hplc_column_post_swap_20260315.jpg" (2.4 MB)
2026-03-22 08:11:33 UTCd.okoyeUSER j.riley role TECHNICIAN → SENIOR_TECHNICIAN
2026-03-31 17:00:00 UTCsystemScheduled report Q1-2026-AUDIT-PACK generated 142 records exported by s.chen
§ 5
2 deletionsDeletion Log — Dual Approval
Record deletion requires a second authorized user to approve the request. Both the request and approval are permanently logged. Deleted records are retained in this log with full attribution.
DEL-2026-00128 Feb 2026
Record deletedWO-2026-0098 (draft, never assigned — created in error)
Requested byd.okoye
ReasonCreated in error during bulk import test. Never assigned or actioned.
Approved bys.chen
Approval timestamp2026-02-28 11:04:17 UTC
DEL-2026-00210 Mar 2026
Record deletedCAL-2026-041-DUP (duplicate calibration entry created by system sync error)
Requested byp.nair
ReasonDuplicate of CAL-2026-041-01 created by integration sync on 2026-01-14. Original record intact.
Approved byt.bach
Approval timestamp2026-03-10 14:22:08 UTC
§ 6
6 accountsUser Access Summary
| User ID | Name | Role | Last active | MFA |
|---|---|---|---|---|
| s.chen | Sarah Chen | QA Manager | 31 Mar 2026 | ENABLED |
| d.okoye | David Okoye | System Administrator | 31 Mar 2026 | ENABLED |
| t.bach | Thomas Bach | Maintenance Supervisor | 31 Mar 2026 | ENABLED |
| j.riley | James Riley | Senior Technician | 29 Mar 2026 | ENABLED |
| p.nair | Priya Nair | Technician | 28 Mar 2026 | ENABLED |
| ext.auditor | FDA Audit Account | Auditor (read-only) | 15 Mar 2026 | ENABLED |
No shared accounts. All 6 users have unique IDs. Auditor account is read-only and time-boxed (expires 30 Apr 2026).