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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 serves regulated businesses in biotech, pharma, defense, and healthcare. Passing an assessment is table stakes; the real work is being able to prove compliance quickly, any day of the year.

We map your obligations to a concrete plan, build the technical controls on the Microsoft platform you already license, and keep the evidence current, so an assessment confirms what your systems already do.

How the Pieces Fit

One Control Backbone

Identity, access, audit trails, and monitoring. Strip away the acronyms and every framework asks the same four questions. Who can get in? What can they touch? Is every change recorded? Would you notice a problem? We implement those controls once, using the Microsoft security tools you already license, then map the same backbone to each framework's specific language.

Audit-ready, continuously

Evidence collection stops being a fire drill. When the auditor or a customer's security questionnaire arrives, the access reviews, logs, and policies already exist and are already current, because they are how your environment runs every day.

Frequently Asked Questions

All questions
Do you run the audit or certification itself?

No. Auditors and assessors have to stay independent, so the same firm cannot build your controls and certify the result. We build the controls, assemble the evidence, and sit beside you during the assessment, so the auditor finds a running system rather than a scramble.

What happens in the first 90 days?

Weeks one and two are access and visibility: admin roles audited, MFA enforced, monitoring on your most critical systems, and a shared password vault. Weeks three to eight set the baseline: licensing rationalized, device management everywhere, backups running and test-restored. By week 13 you have a steady rhythm: a weekly status call, a patch cadence, playbooks you own, and a 90-day review that sets the roadmap.

Do you require long-term contracts?

No. Our standard commitment is a rolling 90 days, so we earn your business every quarter. Everything we build lives in your own Microsoft tenant with nothing proprietary in the way, which keeps that promise real: you could hand the keys to any provider tomorrow.

How does pricing work?

Managed services run at a flat monthly rate per person, which covers their primary device; shared and additional devices are a small add-on. Project work is hourly and quoted in writing before it starts, or converted to a fixed monthly fee when you want budget certainty. Microsoft licensing passes through at list price.

Related reading

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Latest

Jul 16, 2026CMMC and your ERP: why permissions alone won't pass an auditA defense manufacturer wanted to store controlled data in one ERP and lock it down with user permissions, but that's not how compliance works.Cross-platformJul 16, 2026CMMC and your Microsoft 365 tenant: why GCC high changes what software can connectA defense-adjacent manufacturer heading into a CMMC mock audit learned that a government-cloud Microsoft tenant can quietly limit which apps integrate with it.Microsoft SecurityApr 22, 2026CMMC level 2 for small defense suppliers: wall off your CUI instead of moving the whole companyWhen 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.Microsoft SecurityApr 16, 2026Your 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.Microsoft 365Apr 7, 2026FDA validation just changed (CSV to CSA): keep your quality system out of your ERPThe 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.Business Central

See where you stand. Then move forward.

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