Overview
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.
How We Work
Gap assessment
We review your records, signatures, and systems against Part 11 and give you a prioritized, plain-English gap list.
Remediation
We implement the controls: validated systems, audit trails, access management, and documented procedures.
Audit readiness
We keep evidence organized and controls maintained, so an inspection is a checklist rather than a scramble.
What's Included
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.
Implementation Options
Three ways to start, depending on how much certainty you want before you commit. Estimates and rates are quoted in your proposal.
T&M Remediation
- The full remediation on time and materials, billed to actual hours as consumed
- A written estimate up front, revisited at every phase gate
- Design and build run in parallel: the blueprint evolves while early phases are already being delivered
- Scope stays flexible, with changes approved through a written change order
- Simpler footprints with a clear picture of their requirements
- Teams comfortable steering scope as the work unfolds
Fixed-Fee Gap Assessment & Roadmap
- The first phase of a full remediation, run as a standalone engagement with its own deliverables (we call it Phase 0)
- Current state documented, future state designed, and the remediation blueprint delivered
- A fixed-fee remediation proposal, priced against confirmed scope
- Deliverables are platform-agnostic, not tied to Microsoft or to us, and detailed enough for any qualified partner to quote a fixed fee
- The fee is credited in full toward the remediation if you proceed with us within three months
- Complex or unclear scope, where guessing is expensive
- Boards and leadership teams that prefer the certainty of a detailed roadmap and fixed-fee scope before implementation kicks off
Fixed-Fee Remediation
- Follows a completed Discovery & Design engagement
- The remediation at a fixed price, quoted against the scope confirmed in discovery and design
- Milestone billing tied to deliverables you can verify
- Change orders only when the scope itself changes
- Budget certainty required before kickoff
- Regulated or board-governed purchases
Support & Training Options
Compliance is a program, and readiness fades without upkeep. Choose how much of the program we carry. The flat-fee program runs on a rolling 90-day commitment; readiness projects are standalone.
T&M readiness project
- Gap assessment against FDA 21 CFR Part 11, scoped in writing and billed hourly
- Remediation of findings, prioritized by risk
- A roadmap you could execute with any provider
- A first engagement, or a deadline-driven push
- Teams with internal owners who need expert hands
Flat-fee compliance program
- Reduced professional services rates for your remediation
- Continuous monitoring of the technical controls
- Evidence collection that stays current instead of piling up before audits
- Policy reviews and security awareness training
- Support during assessments and customer security questionnaires
- Businesses where FDA 21 CFR Part 11 is a standing customer or regulator requirement
- Leadership that never wants to scramble before an audit again
Fully managed IT & compliance
Everything in the flat-fee compliance program option, plus managed IT services:
- Our lowest professional services rates for your remediation, as part of a holistic ongoing engagement
- The IT operation underneath the controls, run by the same team
- Helpdesk, patching, backups, and vendor management
- Security monitoring, threat response, and email security
- SLA on system-blocking issues
- Regulated companies without internal IT
- Teams tired of compliance and IT vendors pointing at each other
Who This Is For, and Who It Is Not
A strong fit if
- You are a biotech, pharma, or medical device company moving records off paper.
- An inspection or audit is on the calendar, and audit trails, access control, and signatures have to be evidenced.
- Regulated work runs in Microsoft 365, SharePoint, or Business Central, and those systems need to come into scope.
- Your quality documentation is in place and the technical controls behind it were never validated.
- You are pre-approval and want the record-keeping foundation in before the submission.
A poor fit if
- You need a full quality management system with document control and training records. That is a dedicated quality platform, and we work alongside one rather than replace it.
- You want the documentation without changing the underlying systems. The evidence has to describe controls that exist.
- Your records are on paper and staying there. Part 11 governs electronic records, so there is nothing yet to bring into scope.
Frequently Asked Questions
All questionsWhat is FDA 21 CFR Part 11?
Part 11 is the FDA's rule for electronic records and signatures. If a digital record replaces paper in a regulated process, the system has to prove who did what and when, enforce sign-offs, and prevent silent changes. We build those controls into the Microsoft systems you run.
How is this different from staying on paper, or buying a validated suite?
The traditional answer is staying on paper binders, or buying a monolithic validated suite. We take a third path: implement the controls on the platform you already license, with validation support, so compliance stops being a separate system to buy and babysit.
Does Part 11 apply to us, and when should we tackle it?
It applies to life-sciences companies replacing paper records in regulated processes: pre-launch pharma, medical devices, labs. It gets urgent when production is scaling and the next FDA interaction is a matter of when, not if. Timing matters in the other direction too: if your processes still change weekly, locking them into validated systems too early creates churn. Stabilize the process, then validate it.
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.
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.
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 do you handle training?
Role-based and timed close to go-live so it sticks: finance, operations, and quality each learn their own workflows, in your system with your data. After go-live, support sessions run as live screen shares that double as training, and flat-fee plans include training for new hires and on each Microsoft release wave.
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