Warehouse Environmental Monitoring Jira-Based Electronic Log — Solution Design

This document defines the approved solution design for generating, executing, and retaining auditable evidence for warehouse environmental monitoring using Jira as a controlled electronic log.

This design supports compliance with 21 CFR Part 111 and NSF/ANSI 455-2 requirements using a risk-based, low-complexity electronic recordkeeping approach.

1. Scope

This solution applies to routine and scheduled monitoring of warehouse environmental conditions, including:

It supports the following Auditable Artifact:

2. Control Objective

Ensure warehouse materials are stored under appropriate environmental conditions that protect against contamination, damage, or degradation, and that environmental conditions are documented contemporaneously, traceable to the individual performing the check, and retained as GMP records.

3. System of Record Declaration

Jira is the approved electronic log and system of record for warehouse environmental monitoring data covered under this control.

Jira is used to:

This solution is classified as a low-risk electronic record supporting facility and storage condition monitoring and does not directly determine batch disposition decisions.

4. Roles & Responsibilities

Role Responsibilities
Warehouse Personnel Perform environmental checks as scheduled and record measurements directly into the assigned Jira work item at the time of performance.
Warehouse Supervisor Ensure assigned checks are completed on time and escalate missed or abnormal results.
Quality Assurance (QA) Periodically review completed Jira records for completeness, trends, and excursions, and ensure appropriate follow-up actions are taken.
Jira Administrator Maintain workflow controls, access restrictions, and configuration required to support data integrity.

5. End-to-End Evidence Flow

  1. Jira automatically generates a scheduled Warehouse Environmental Monitoring work item.
  2. The work item is assigned to an authorized Warehouse role.
  3. The assigned individual physically performs the environmental check in the warehouse.
  4. Temperature, humidity, and observations are entered directly into required fields within the Jira work item at the time of performance.
  5. The work item is transitioned to Completed.
  6. Upon completion, workflow controls restrict further edits by operational users.
  7. Any excursions or abnormal conditions are escalated per SOP-WH-STOR and QA procedures.
  8. QA performs periodic review and trending of completed records.

6. Data Integrity & Record Controls

Control Element Implementation
User accountability Entries are associated with authenticated Jira user accounts.
Contemporaneous recording Measurements are entered at the time the check is performed.
Required data fields Key measurement fields must be completed before ticket closure.
Edit restriction Once closed, records are read-only for operational users.
Audit trail Jira maintains an automatic history of record creation, edits, and status changes.
Administrative changes Any administrative edits are logged and subject to QA oversight.
This control design aligns with ALCOA+ principles through attribution, legibility, contemporaneity, and traceability appropriate to the risk level of the activity.

7. Audit Positioning Statement

Warehouse environmental monitoring data is recorded directly in Jira, which serves as the electronic log and system of record for this activity. Workflow controls restrict edits after completion, and QA provides periodic review and oversight. This approach provides improved execution discipline and data integrity compared to manual paper logs.

8. Record Retention

Environmental monitoring records maintained in Jira are retained in accordance with 21 CFR §111.605 and internal record retention requirements. Records remain retrievable for the full retention period.

9. Known Limitations & Risk Acknowledgement

Jira is not validated as a Part 11 system and does not provide cryptographic immutability. This solution is intentionally limited to low-risk environmental monitoring activities and is supported by procedural controls, access restrictions, and QA oversight.

Document Status: Controlled — Solution Design Reference Approved for use under SOP-WH-STOR