FDA 21 CFR Part 11

Electronic-records and electronic-signature readiness for FDA-regulated environments in biotech, pharma, and life sciences.

Overview

Compliance built into your systems, not bolted on.

For life-sciences companies, FDA 21 CFR Part 11 governs how electronic records and signatures must be controlled. We help you build the technical controls, audit trails, access management, validation, into the Microsoft systems you already run.

Rather than treating compliance as a separate burden, we engineer it into your environment so you stay inspection-ready as you grow.

What's included

Audit-ready records, built into your systems.

Gap assessment

A clear read on where your systems stand against Part 11 requirements.

Access and identity controls

Role-based access, MFA, and least-privilege aligned to the rule.

Audit trails

Tamper-evident records of who did what, when, across regulated systems.

Electronic signatures

Compliant e-signature workflows where records require them.

Validation support

Documentation and validation to evidence your controls.

Ongoing readiness

Monitoring and review so you stay inspection-ready over time.

From the Insights desk

Reading that goes deeper.

All insights

Business Central

FSMA 204 and Lot Traceability: What Food and Produce Distributors Need From an ERP

FSMA 204 makes lot traceability and standardized product identifiers non-optional for higher-risk foods. Here is what that means for your ERP, and the build-versus-buy choice that comes with it.

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Business Central

Getting Off Paper: ERP for Small Regulated Manufacturers

For a small regulated manufacturer still running on paper and spreadsheets, moving to an ERP is as much a change-management project as a software one. Here is what the system needs to enforce, and how to bring the team with you.

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Microsoft Security

CMMC Level 2 for Small Defense Suppliers: Wall Off Your CUI Instead of Moving the Whole Company

When controlled data touches only a slice of your work, you can shrink CMMC Level 2 scope by walling CUI into a governed enclave instead of dragging the whole company in.

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Explore the other ways we help align our clients' businesses.

CMMC HIPAA SOC 2

Stay inspection-ready.

Build FDA 21 CFR Part 11 controls into the systems you already run.