Protect your data. Protect your batches. Protect your reputation.

Control systems engineered for FDA-compliant electronic records, audit trails and e-signatures — built into every regulated Terriva blender.

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Regulation

21 CFR Part 11

Authority

US FDA

Applies to

E-records & signatures

Validation

URS / FAT / SAT
21 CFR Part 11

Why 21 CFR Part 11 matters

In regulated manufacturing, data integrity is a legal and operational necessity. The FDA’s 21 CFR Part 11 defines how electronic records and signatures must be managed — ensuring all digital information is secure, traceable and tamper-proof. In powder processing, that applies to batch records, quality control data and equipment logs.

Non-compliance can lead to rejected data, regulatory action and production delays. Compliance proves your electronic records are reliable, your batches defensible, and your audit posture sound.

What a compliant system must provide

Four foundational capabilities define a 21 CFR Part 11-ready control system.

Role-based access

Secure, individual user accounts with permission levels matched to operational responsibility.

Full audit trails

Every action, change and approval logged with timestamp, user identity and reason for change.

Verified e-signatures

Authenticated electronic signatures with traceable user identity and clear signing intent.

Tamper-proof data

Records protected against loss, alteration or unauthorised access throughout their lifecycle.

How Terriva delivers ATEX compliance

Our control systems and software are built with Part 11-ready functionality — helping manufacturers meet FDA expectations with confidence. From encrypted audit trails to validated e-signatures, our technology ensures your electronic data is trustworthy, compliant and inspection-ready.

Encrypted audit trails

Every action logged in tamper-resistant records — secure throughout the batch lifecycle.

Validated e-signatures

Authenticated electronic signatures with clear user identity and signing intent.

Role-based user access

Permission levels matched to operational responsibility — operator, supervisor, QA.

Inspection-ready records

Export, search and produce records on demand — built for regulatory audit response.

21 CFR Part 11 control system

Why this matters for your operation

Data integrity assured

Every record is reliable, traceable and defensible — the foundation of regulated manufacturing.

Audit-ready at all times

Inspectors can review batch records on demand — without scrambling for documentation.

Faster batch release

Validated electronic records eliminate paper trails — accelerating QA review and approval.

Reduced regulatory risk

Non-compliance can mean rejected data, regulatory action and production delays — avoided by design.

Quality by Design support

Pairs with PAT and validated control to embed quality directly into the manufacturing process.

Reputation protected

Sound data integrity signals operational maturity to regulators, customers and partners.

Validation note

Part 11 compliance is a shared responsibility between equipment supplier and end user. Terriva provides Part 11-ready systems and full URS, FAT and SAT documentation; the customer completes installation qualification (IQ), operational qualification (OQ) and process validation in their own facility. Our compliance engineers support every stage of that journey.

Stronger together

Part 11 compliance is most powerful when paired with continuous monitoring and other Terriva capabilities.

Next steps

Need a 21 CFR Part 11-compliant blending system?

Reach out to a Terriva expert for a free consultation meeting.
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