All four pillars
Align

Compliance built in, not bolted on.

FDA, CMMC, HIPAA, and SOC 2 readiness for regulated industries like biotech, pharma, and defense.

Compliance built in.

Align is compliance engineered into the systems you already run, not bolted on after the fact. For regulated businesses in biotech, pharma, defense, and healthcare, the controls that keep you inspection-ready should be part of how you work, every day.

We map your obligations to a concrete plan, build the technical controls, and assemble the evidence, so an assessment is a confirmation rather than a scramble.

The standards we get you audit-ready for.

Related reading.

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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Microsoft 365

Your Staff Are Already Using AI. For a HIPAA-Regulated Org, Governed Copilot Beats Banning It.

When staff paste protected health information into public chatbots, you can't ban your way out; a governed Microsoft 365 Copilot keeps the data in your tenant.

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Business Central

FDA Validation Just Changed (CSV to CSA): Keep Your Quality System Out of Your ERP

The FDA's move from computer system validation to Computer Software Assurance, plus keeping quality management out of the ERP, can shrink the biggest cost in a regulated ERP project.

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