TRACKS Audit Hub

Centralized Audit Hub for pharma. Search and compare parameters without endless PDFs.

Have reliable data at hand for audits, deviation investigations, product release and process optimization.

TRACKS Audit Hub logs audit trails automatically from any system or device and puts them in one central database, where you can find what you're looking for in minutes.

Features and functionality Download data sheet

Screen showing the UI of TRACKS Audit Hub with parameters neatly sorted and color-coded to highlight changes between FAT and SAT

Haunted by paper stacks, scattered files and useless PDFs?

You're not alone. Basic QA and validation processes shouldn't have to involve 37 open tabs with mile-long PDF lists. And yet they do.

The cause? Decentralized logging in each level 1 or 2 component and an abundance of paper forms.

It's messy, slow and prone to human error.

Goodbye to the paper stacks

Find the data you need in a matter of minutes

TRACKS Audit Hub automatically logs audit trails from components, machines, production lines or entire facilities and centralizes them in one searchable database, so you can:

Check if you're out of compliance because a critical parameter has been changed.
Compare parameters at FAT/SAT or from batch to batch.
Instantly spot any parameter changes and speed up revalidation.
Quickly return to original machine settings if performance drops due to parameter changes.
Have complete and reliable documentation at hand for audits.
Investigate non-conformances and deviations faster.

21 CFR part 11 compliance has never been easier

Sort, filter, group, save and export audit trails to any enterprise system.

TRACKS Audit Hub generates audit trails automatically and immediately whenever any electronic record, such as a parameter, changes.

Audits adhere to key regulation such as 21 CFR part 11.

Explore TRACKS Audit Hub features and functionality here

User management

TRACKS Audit Hub integrates with your Active Directory to handle all users and access rights.

Access rights are role-based and support users having different roles on different machine groups.

Authentication and authorization is centralized in TRACKS Audit Hub.

Audit trail

Audit trails are generated immediately in TRACKS Audit Hub whenever any electronic records, such as parameters, are changed.

TRACKS Audit Hub also supports the storage of audits from other systems and offers custom importers and exporters, for seamless integration with external systems. Standard importers and exporters exist for XML, JSON, SQL servers, OPC UA, and CSV files.

Audits adhere to regulations and include at least the following:

Timestamps with date, time, and time zone.
Clear, legible, and indelible records.
Information about who made the changes.

Events such as authentication and alarms are automatically saved in the audit trail.

All audit table columns can be easily sorted, filtered, grouped, and saved in physical formats such as PDF or CSV.

Critical parameter tracking

Parameters in TRACKS Audit Hub are data obtained from other systems.

TRACKS Audit Hub retains a full history of all parameters, ensuring a detailed record of changes over time.

Parameters offers the following features:

Monitoring: Parameters can be marked as critical for easy monitoring.
Automatic Audit Trails: All changes to parameters are automatically logged into the audit trail.
Custom importers and exports: The system provides a standard interface for third-party systems to enable custom import and export of data.

Baseline snapshot and comparison

TRACKS Audit Hub allows users to create baselines, which are snapshots capturing the state of all parameters at a specific moment. Users can easily view or compare these baselines within the application.

Parameters across the system can be compared at any two given points in time, facilitating easy comparison during Factory Acceptance Tests (FAT) or Site Acceptance Tests (SAT).

When comparing baselines, new parameters, changes, and deleted parameters are color-coded. Baselines can also be exported to physical formats such as PDF or CSV.

Search and filter parameter/audit data

Audit data and parameters can be easily sorted, filtered, grouped, and saved in physical formats such as PDF or CSV.

Download data sheet

One Audit Hub for everyone

Production management

Increased productivity
Faster product release and shorter changeovers
More resilient production setup

Data-backed decisions
Reliable, searchable data
Release with confidence
Faster non-conformance investigations
Ready for FDA audits.

Project Manager

Simplified processes
More efficient FAT/SAT and (re-)validation

TRACKS Audit Hub is made for pharma

Acting as a smart bridge between any machine component at level 1 and the Enterprise System at level 3, TRACKS Audit Hub allows for efficient, centralized audit trails and monitoring of critical parameters.

This makes it ideal for pharma and other regulated industries.