Polwax › Dashboard

Software

Polwax Config 21CFR

Validated-system framework

Logger Data

0

Imported records

Audit Events

1

Time-stamped events

Integrity

Ready

Hash-chain check

Compliance Control StatusCONTROLLED

Unique user identification

Individual user identity for controlled actions.

Authority checks

Role-based access to configuration and approval.

Audit trail

Time-stamped creation and modification history.

Electronic signature

Two-factor signing workflow with meaning.

Record protection

Read-only source data and controlled report records.

Validation evidence

IQ/OQ/PQ evidence register and version control.

System Information

Software	Polwax Config 21CFR
Version	2.4.0
Mode	Local / Controlled
Current User	Administrator
Time Zone	Asia/Kolkata
Validation Status	Validation required before regulated use

Important: This HTML application implements a Part 11-oriented control framework and demonstration workflows. It is not, by itself, a regulatory certification. Production use requires documented system validation, risk assessment, SOPs, security controls, backup/restore testing, infrastructure qualification and approval by the responsible quality unit.

Polwax › Datalogger Configuration

Datalogger ConfigurationControlled Configuration

Device Name

Device ID / Serial No.

Model

Firmware Version

Logging Interval

Time Zone

Start Mode

Memory Mode

Data Format

Channel ConfigurationConfigure measurement labels, units and limits

Channel	Parameter	Unit	Low Limit	High Limit	Enabled

Polwax › Import .CUB Data

Controlled Data ImportOriginal data preserved

Source record rule: Imported source data is treated as read-only. The application creates a controlled working copy for report generation and records the import event in the audit trail.

Source File

—

Original filename

Records

0

Valid timestamped records

First Record

—

Logger-local time

Last Record

—

Logger-local time

Imported Observation Data0 records

Polwax › Report Generator

Report Records

0

Records in selected range

Report Type

Controlled

21 CFR workflow

Source Integrity

—

Import hash

Approval

Draft

Electronic signature required

Report DefinitionDraft until signed

Report Title

Report No.

Report Version

Range Type

Start Date

Start Time

End Date

End Time

Report Time Zone

Report Channel SelectionOnly selected channels will appear in the report, graph and observation table.

0 channels selected≤ 10 channels: A4 Portrait | > 10 channels: A4 Landscape

The report filter compares the original logger-local timestamp fields exactly as recorded by the logger. No browser timezone conversion is applied.

POLWAX ENVIRONMENTAL DATA REPORT

POLWAX CONFIG 21CFR • CONTROLLED ELECTRONIC RECORD

Environmental Monitoring Data Report

21 CFR Part 11 controlled workflow • Report status: DRAFT

REPORT DETAILS

TREND VISUALIZATION

STATISTICAL SUMMARY

OBSERVATION REGISTER

ELECTRONIC APPROVAL

Polwax Config 21CFR • Controlled CopyPage 1

Polwax › Report Repository

Controlled Report RepositoryNamed Records

Controlled record rule: Reports are retained with their report number, title, source integrity, selected channels, date/time range, status and electronic approval history. Draft reports are view-only. Download/export is enabled only after Administrator approval.

Polwax › Audit Trail

Computer-Generated Audit TrailHash Chain Enabled

Audit trail principle: Significant creation, modification, approval and access events are recorded with user, timestamp, action and reason. In a production system, the audit repository must be protected from user modification and disabling.

Polwax › Electronic Signatures

Signature Policy

Signature Components	User ID + Password + action meaning
Signature Meaning	Review / Approval / Configuration Change
Signature Binding	Bound to controlled record ID
Re-signing	Required after material change
Accountability	Individual user credentials

Sign Controlled Action

Action

Reason / Comment

Polwax › Users & Roles

User & Role AdministrationAdministrator only

User ID

Full Name

Role

Password / Access Policy

Unique User ID

No shared accounts permitted for regulated actions.

Password Complexity

Minimum length, complexity and expiration policy.

Account Lockout

Lock after repeated unsuccessful authentication attempts.

Session Timeout

Automatic logout after inactivity.

Polwax › Validation

Computerized System ValidationNot yet qualified

Validation is required: FDA guidance describes validation as a control for computerized systems. The application provides a validation evidence register, but execution, approval and release remain the responsibility of the regulated organization.

URS Approved

User Requirements Specification approved.

Risk Assessment

Data integrity and patient/product quality risks assessed.

IQ Completed

Installation Qualification executed.

OQ Completed

Operational Qualification executed.

PQ Completed

Performance Qualification executed.

SOP Approved

Operating, security, backup and audit review SOPs approved.

Validation Evidence

Polwax › System & Security

Security Controls

Access Control

Role-based permissions.

Authority Checks

Controlled actions restricted by role.

Operational Checks

Input and workflow checks.

Device Checks

Device identity and source verification.

Record Retention

Retention period and archive policy.

Backup / Restore

Controlled backup and restoration testing.

Encryption

Recommended for production storage and transport.

Time Reference

Explicit timezone and timestamp reference.

System Time & Record Integrity

Current Time	—
Timezone	Asia/Kolkata
Audit Hash	—
Source Data	Read-only after import
Report Status	Draft until electronic approval