Built for the Highest Standards of Quality and Compliance

Life sciences manufacturers operate under rigorous regulations and tight tolerances. TrakSYS delivers digital traceability, real-time quality enforcement, and audit-ready records, ensuring you meet regulatory requirements without slowing down innovation.

Explore TrakSYS

Request a Demo

Compliance Isn’t
Optional. It’s Essential.

Manufacturers in pharma, biotech, and medical devices must meet the highest standards of quality, documentation, and traceability. TrakSYS helps you enforce SOPs, capture digital batch records, and respond quickly to audits—all while supporting continuous improvement.

Enforce GMP workflows with digital records.

Monitor quality in real time, with no delays.

Enable end-to-end traceability of materials, batches, and products.

Generate audit-ready reports at the click of a button.

TrakSYS gives you the digital backbone to support your GMP compliance goals while optimizing operations.

Brochure

TrakSYS-Powered Compliance

5 pages · PDF · 4 min read

TrakSYS-Powered Compliance

Regulatory pressure doesn't ease up, and neither should your traceability. See how TrakSYS gives manufacturers the audit-ready records, electronic signatures, and closed-loop controls needed to meet FDA, GMP, and ISO requirements without slowing down the line.

What is inside

Electronic batch records and e-signatures built for 21 CFR Part 11 and Part 820

Real-time non-conformance alerts with root-cause context

Configurable audit trails across users, actions, and system changes

Get the brochure

5873450b-8b91-4533-bc18-54f2a16d9c39

What You Get
with TrakSYS

Digital Batch Records

Log every step of your production process—seamlessly.

Deviation & CAPA Management

Track and resolve non-conformances to stay audit-ready.

Regulatory Compliance Support

Meet FDA, EMA, and GMP requirements with confidence.

Audit-Ready Reporting

Instant access to quality and compliance records for inspections.

Real-World Results:
A Life Sciences Success Story

Discover how TrakSYS helped AstraZeneca digitize batch records, enforce quality checks, and maintain audit readiness—all while empowering operators and improving efficiency.

Download the Case Study

TrakSYS Powers Life
Sciences Excellence

Leading life sciences manufacturers trust TrakSYS to meet regulatory requirements, ensure product quality, and drive continuous improvement all from a single, secure platform.

Request a Demo