Compliance Is Mandatory. Complexity Doesn’t Have to Be.

In regulated manufacturing, compliance isn’t a goal—it’s a requirement. TrakSYS delivers digital traceability, enforced quality protocols, and real-time audit-ready data, giving teams the clarity and control they need to meet global standards, reduce risk, and streamline operations.

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In Regulated Industries, Paperwork Isn’t Enough

Manual logs and fragmented systems expose you to compliance gaps, quality issues, and costly recalls. TrakSYS helps you proactively manage quality, deviations, and documentation—so you stay ahead of audits and in control of operations.

Enforce SOPs and quality checks digitally.

Ensure full traceability from raw material to finished good.

Generate audit trails with no extra work.

Respond instantly to deviations or non-conformances.

TrakSYS gives us real-time digital traceability, not just after-the-fact documentation.

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

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What You Get
with TrakSYS

Digital Batch Records

Capture every step, material, and action automatically.

Built-In Quality Enforcement

Ensure critical checks and sign-offs are completed—every time.

Deviation & CAPA Management

Track and resolve non-conformances with full traceability.

Audit-Ready Reporting

Instant access to complete digital records for inspections and compliance events.

Stay Compliant. Operate with Confidence.

TrakSYS is trusted in life sciences, food and beverage, and other regulated industries to ensure compliance and improve performance while doing so.

Case Study

See How AstraZeneca Streamlined Compliance and Boosted Performance

Learn how one of the world’s leading pharmaceutical companies uses TrakSYS to improve OEE, digitize records, and empower plant teams—all while meeting the rigorous demands of a regulated environment.

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“TrakSYS is used every day by the majority of our plant’s workforce to better understand productivity. TrakSYS is a business-critical application for our plant, as it would not be possible for us to sustain our continuous improvement goals and objectives without it.”   

— AstraZeneca