Pharma IT Usually Arrives in Pieces
A growing pharmaceutical company typically assembles its systems one urgent need at a time: an ERP partner for the implementation, a compliance consultant for the FDA work, an IT provider for the helpdesk, and a validation contractor when an inspection approaches. Each does good work. The gaps sit between them.
Upgrades stall because the people who patch a system and the people who own its validation work for different companies. Audit prep becomes a project because the evidence lives in four places. And when something breaks at a seam, the fix has to cross three contracts before it reaches the person who can make it.
Our four pillars were built to be one operating model for exactly this situation: the systems that run the business, the discipline that keeps them safe, the automation that removes manual work, and the compliance that proves all of it, carried by one team.
All Four Pillars, Through a Pharma & Life Sciences Lens
The same operating model we bring to every engagement, tuned to the rules and realities of your field.
An ERP That Knows What a Lot Number Is
Dynamics 365 Business Central runs financials, inventory, purchasing, and production with lot and batch traceability, expiration dating, and quality holds, extended by vetted life-science add-ons where the platform needs them, like compliant electronic signatures. Power BI reads live from the same system, so batch margins, expiry exposure, and cash are questions you can answer today rather than at month end.
Dynamics 365 Business Central
Power BI & Fabric AnalyticsIT Support That Respects a Validated Environment
Helpdesk, patching, backups, and identity, run in step with your change control instead of around it. Updates to validated systems are scheduled, documented, and reversible, and the engineers who touch your environment know which systems are GxP before they touch them. Security monitoring watches identity, email, and endpoints continuously.
Managed IT
Security Operations
Microsoft 365Automation That Leaves an Audit Trail
The paperwork burden in pharma is real: document intake, deviation records, CAPA workflows, and certificates of analysis. We automate the movement of that information with tools that log every step, and we deploy Copilot with governance first, so AI works inside your tenant and regulated data never leaves it.
Copilot & Azure FoundryCustom AI & Workflow Automation
Power AutomateInspection-Ready Every Day, Not Just Audit Week
FDA 21 CFR Part 11 controls, electronic records, signatures, audit trails, and access management, engineered into the Microsoft systems you already license. We follow the FDA’s risk-based Computer Software Assurance approach to validation, so you validate what matters instead of documenting everything twice. Evidence stays current because it is how the environment runs.
FDA 21 CFR Part 11SOC 2HIPAAHow an Engagement Comes Together
Business Central goes in with validation in mind: requirements traced, risks assessed, and the quality system kept out of the ERP so both can change without re-validating everything.
Part 11 controls land on the same platform: who signed, what changed, and when, recorded across the ERP and the infrastructure under it, with evidence organized as it is created.
The same team answers the helpdesk, patches in step with change control, and keeps backups, monitoring, and access reviews current, quarter after quarter.
When the ERP consultant, the compliance lead, and the support engineer share one ticket queue, nothing falls between vendors, and an FDA inspection confirms what your systems already do.
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 Implementation
- The full implementation 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 Discovery & Design
- The first phase of a full implementation, run as a standalone engagement with its own deliverables (we call it Phase 0)
- Current state documented, future state designed, and the implementation blueprint delivered
- A fixed-fee implementation 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 implementation 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 Implementation
- Follows a completed Discovery & Design engagement
- The implementation 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
However the engagement starts, ongoing support takes one of three shapes. The same structure applies across every service line on this page; rates and specifics live in your proposal.
T&M support & training
- A named bench for the systems we build and run, billed hourly as consumed
- Training sessions and documentation, scheduled as you need them
- No monthly commitment
- Teams with internal owners who need expert hands occasionally
- A first engagement, before committing to a program
Flat-fee service-line support
- Reduced professional services rates for your implementation
- Unlimited application support and training for the platforms we implement
- A predictable monthly fee on a rolling commitment
- Proactive improvements, not just break-fix
- Teams that want predictable cost and continuous improvement
- Businesses where the platform is now how the work gets done
Fully managed IT & applications
Everything in flat-fee service-line support, plus the IT operation underneath:
- Our lowest professional services rates for your implementation, as part of a holistic ongoing engagement
- Helpdesk, patching, backups, and vendor management, run by the same team
- Security monitoring, threat response, and email security
- An SLA on system-blocking issues
- Companies without internal IT
- Teams tired of application and IT vendors pointing at each other
Frequently Asked Questions
What 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.
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.
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.
What are these add-ons (ISVs) you keep mentioning?
Business Central covers finance, inventory, and operations out of the box. Industry-specific needs, like catch weight for food distribution, FDA-compliant electronic signatures, or distributor EDI, are covered by vetted add-on products built for Business Central. We name them during design, quote their licensing before you sign anything, and remain your single point of contact. You never call Microsoft or the add-on vendor.
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.
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