Strict Standards. Zero Margin for Error. SYSPRO Documents Every Step.
Trace every component, document every process, and stay audit ready in one connected system. Mareba configures SYSPRO around how you manufacture, validate, and comply, then stays on to keep it working.
SYSPRO Premium Solutions Partner
for businesses across Africa
One of the Most Regulated Industries. Documentation Is Survival.
Medical device manufacturers operate under strict standards where every process must be controlled and provable. These are the gaps that quietly put compliance, and your business, at risk.
Compliance Documentation Overload
FDA, ISO, and other standards demand documentation for every step, and producing and maintaining it by hand under audit pressure is slow and error prone.
Traceability That Must Be Complete
You need full genealogy from component receipt to finished device, and any gap in the record is a gap a regulator or a recall will expose.
Design Changes Without Control
An uncontrolled change to a design or bill of materials can put an unapproved specification into production, a serious compliance failure.
Complaints and CAPA That Stall
Without a controlled workflow, customer complaints and corrective actions get lost, and unresolved issues are exactly what auditors look for.
Recalls That Move Too Slowly
When a defect surfaces, finding and quarantining every affected device fast is the difference between a contained action and a patient-safety crisis.
No Audit Trail of Who Did What
Regulators expect a verifiable record of every action and approval, and a system without electronic signatures and audit trails cannot prove it.
Every Compliance Pressure Has a Module Built to Carry It.
SYSPRO is purpose-built for regulated manufacturers, not adapted from generic business software. Each capability maps to a requirement that an auditor, a regulator, or a recall will test. Mareba switches on the ones your operation actually needs.
Your SYSPRO Can Also Include
Lot and Serial Traceability
Tracks serial and lot numbers at every stage from component receipt through production, packaging, and distribution, giving you full genealogy and a complete device history record on demand.
Quality Management
Builds in electronic signatures, audit trails, and non-conformance management that support FDA 21 CFR Part 11 and ISO 13485, so every transaction is documented and traceable when an audit comes.
Engineering Change Control
Manages the change lifecycle with approval routing and effective-date controls, so you update designs and bills of materials with full revision history and only approved specifications reach production.
Customer Complaints and CAPA
Captures, manages, and resolves complaints with corrective and preventive action workflows, including the review and escalation of defects to enable recalls, so issues are closed out instead of left open.
Product Recall
Lets you rapidly identify, quarantine, and retrieve potentially defective goods, and run mock recalls to test your process, so you can act fast and meet regulatory reporting requirements.
Work in Progress
Provides real-time shop floor control with in-process quality checks and material validation, so every device is built under controlled, documented conditions rather than from memory.
A Global ERP, Configured for How You Run and Where You Run It.
SYSPRO gives you the capability. Mareba makes it fit your processes, your statutory rules, and your market, then stays on long after go-live. That is the difference between software you own and software that actually works for you.
Tax and Statutory Compliance, Handled
We configure SYSPRO to meet KRA, VAT, and eTIMS requirements as part of every Kenyan implementation, and the local statutory rules of each market you operate in. Compliance is built into the setup, not bolted on after.
Multi-Currency and Multi-Company, Across Borders
Sourcing components globally and supplying across borders? We set up SYSPRO multi-currency and multi-company structures to match how your group actually procures, produces, and bills across the region.
Certified Consultants Who Know Regulated Work
Our SYSPRO trained consultants have run real manufacturing rollouts, so the configuration reflects how a regulated manufacturer actually documents and controls production, not how a manual says it should.
Support in Your Timezone, on Your Continent
When a question comes up mid-shift, you reach a local team that works the same hours you do. No overnight tickets, no waiting on a vendor in another hemisphere.
25 Years. 20+ Implementations. 6+ Countries.
We have configured SYSPRO for manufacturers in demanding, regulated markets like yours before. Let us show you what that looks like for your operation.
The Questions Medical Manufacturers Ask Most.
Straight answers on cost, timelines, compliance, and what working with Mareba actually looks like.
It depends on how many sites, users, and processes are involved, but you never figure that out alone. Mareba scopes the project up front, phases the rollout so production keeps running, and draws on more than 20 implementations to keep it on track. Many regulated manufacturers go live within months, not years.
SYSPRO gives you the financial and tax structure. Making it meet KRA, VAT, and eTIMS requirements is part of what Mareba configures during your implementation, along with the statutory rules of any other market you operate in. Compliance is built into the setup, not added as an afterthought.
Yes. SYSPRO provides built-in electronic signatures, automated audit trails, and non-conformance management that support FDA 21 CFR Part 11 and ISO 13485 requirements, with every transaction documented and traceable. Mareba configures those controls to your quality system so compliance is set up from day one.
Yes. SYSPRO's lot and serial tracking gives full genealogy from component receipt to finished device, so you can generate a complete device history record on demand and rapidly identify, quarantine, and retrieve affected goods in a recall. It even supports mock recalls to test your process. Mareba configures traceability to your records.
SYSPRO's Engineering Change Control manages the change lifecycle with approval routing and effective-date controls, so only approved specifications reach production with full revision history. Its complaints and corrective-action workflows capture, escalate, and resolve issues. Mareba sets both up around your approval process.
SYSPRO gives you the quality, traceability, and documentation foundation. Mapping that to your local regulatory and registration requirements is part of what Mareba configures during implementation, alongside the international standards. We set the system up to match the rules you actually answer to, not a generic template.
You are not handed a login and left to it. Mareba trains your team, then stays on with support from people in your timezone and on your continent. When a question comes up mid-shift, you reach someone who works the same hours you do.
Still weighing it up? Talk to our team and we will answer yours directly.
See SYSPRO Running in Your Operation.
Book a free demo with Mareba. We tailor the walkthrough to how you manufacture, document, and stay compliant, and reply within one working day.