As you grow into new markets, the demands increase – on processes, documentation, and regulatory control. We map your compliance gaps and provide you with a concrete basis for the next step. No sales pitch.
The most common findings in FDA and EMA inspections are not technical errors. They are processes that were never built into the system from the start.
Batch records reconstructed manually
Gaps in documentation are one of the most common inspection findings. The right ERP configuration eliminates the problem — and saves weeks per release.
CAPA and deviations without an audit trail Deviation management in email chains and Excel does not meet the requirements for 21 CFR Part 11 or Annex 11. It is a gap that is immediately visible during an audit.
3–6x more costly to fix compliance deficiencies after an inspection than before
60–90 days of revenue are at risk every time a batch release is unnecessarily delayed
Estimates based on industry averages for Life Science companies. Your specific outcome will vary.
A structured half-day meeting with Implema and Epista Life Science. No sales pitch — a basis for decision-making.
Batch release, CAPA, audit trail, quarantine management — we identify where your processes don't hold up to regulatory scrutiny.
Ranked by regulatory risk and business benefit. What must be fixed now, what can wait — and what it costs to wait.
Concrete enough to present to the board or management team. Regardless of whether you choose to move forward with us or not.
“I know we have deficiencies. I don’t know what they’re costing us.”
You see the numbers. But capital tied up in quarantine stock, manual processes in finance and logistics, and lagging reporting mean you’re always working from incomplete information. The workshop gives you a concrete picture of where financial control is failing — and what it costs per quarter.
“We solve it — but we shouldn’t have to solve it.”
Your operational flows work thanks to talented people, not thanks to the system. This creates vulnerability. The workshop identifies where processes are compensating for the ERP system — and what happens when growth demands more.
“I don’t know if what we’ve built is scalable.”
Integrations, customizations, and solutions that were right then. The workshop gives you a technical risk assessment without becoming a design assignment.
“The next audit is a question mark.”
Batch traceability, quarantine stock management, deviation management — everything must be demonstrable. The workshop maps what the system actually supports during an audit, and where you’re plugging holes manually.
GxP, 21 CFR Part 11 and Annex 11 — built-in from day one Audit trail, electronic signatures, and batch records are not features we add later. It’s how we configure Dynamics 365 from the start.
Epista Life Science — validation in the same team Epista are specialists in GxP and CSV. Together we cover ERP configuration and regulatory validation — one team, one responsibility, no coordination in between.
Track record in regulated environments Calliditas Therapeutics was FDA-ready in 9 months. Atlas Antibodies drives global growth — 60,000+ products, 60+ countries — on a system we implemented. We bring the experience from these projects into every workshop.
We work with Life Science companies in growth, under regulatory pressure, with documentation, traceability, and validation requirements that place completely different demands than standard ERP. Our partner Epista Life Science adds specialist expertise in these areas — built-in from the start, not bought in later.
Compliance, validation, and regulated implementations require more than technical expertise. They require a partner who understands your business – not just the system. A Life Science company that was to establish itself on the US pharmaceutical market needed Microsoft Dynamics 365 in place quickly. Implema delivered. On time. Within budget. Fully compliant.
We run an active forum for Life Science companies where customers share experiences, identify common challenges, and build solutions together. You don't just get a consultant — you get access to a collective experience base from companies in exactly the same situation as you.
Before we write a single line of configuration, we find out where you actually are. In close teams with you, we map out which processes are holding you back: batch release flows, quarantine management, traceability gaps, compliance gaps.
Then we gather documentation, make the decisions that need to be made, and ensure that you and your colleagues understand why we do what we do. User acceptance starts here — not on go-live day.
Let's go. Microsoft Dynamics 365 is configured and deployed step by step — with you involved all the way. Batch release, quarantine stock, traceability, and regulatory reporting are built in as standard, not as add-ons later. Just as important: we ensure that your employees don't just understand the new system but actually want to use it. The change is implemented in the organization, not just in the IT environment.
Go-live is not the end — it's the starting point. We continue to work closely with you to develop the system in step with your business: new markets, regulatory updates, increased volume, new Microsoft features. Our job is to help you sift through and prioritize what is actually relevant for you — not to roll out every new update for the sake of it. You grow. The system grows with you.
Yes. We adapt the analysis to your current systems, your industry process, and your growth phase — not to a standard template.
It’s actually the best time to do this analysis. You get a decision basis for the future without having to make a decision today.
Everything is treated confidentially. The workshop is a decision support for you — not the basis for a proposal you haven’t asked for.
Half a day. You book a time that suits you, and we stick to it.
Yes. We have worked with companies under regulatory requirements, with traceability requirements and audit preparation. It’s part of the analysis, not an optional service.
The workshop is free of charge. The decision basis you take with you is concrete. And the insight into what is actually holding you back — that is invaluable.
The workshop is the starting point – not the end goal. Regardless of where you are in your ERP journey, you give yourself a concrete decision basis for the next step.
Key Account Manager Dynamics
Jonny leads Implema's Life Science work within the Microsoft track and runs the network where Life Science companies share experiences and solve common challenges. If you have questions about the workshop or whether Microsoft Dynamics 365 fits your situation — get in touch directly.
Companies that are no longer waiting
We have implemented Microsoft Dynamics 365 for Life Science companies across the entire spectrum — from early commercialization to global scaling. Common to them all: they chose to address their system deficiencies before they became inspection findings.
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