Medical & Regulated Products Implementation Support | BaszGroup

Medical & Regulated Products Implementation Support

ERP, WMS, TMS, OMS, EDI, APIs, traceability, and validated operations support.

Medical and regulated supply chains are different because the work has to hold up under audit. You are not only moving product. You are proving what happened, when it happened, who did it, and whether controls worked.

That changes how implementations must be planned and executed. If your systems maintain records that fall under FDA record requirements, and you choose to keep them electronically, 21 CFR Part 11 becomes part of the design constraint for electronic records and signatures.

It also changes how replacements happen. In regulated environments, legacy systems often hold validated workflows, historical evidence, and reporting that auditors still expect to see. Transitions are often controlled, staged, and sometimes run in parallel longer than anyone wants. FDA guidance on Part 11 even calls out concerns that include validation, audit trails, record retention, and legacy systems.

BaszGroup supports regulated teams through rollouts, takeovers, remediation after go live, and M&A unification where supply chain systems and quality expectations have to stay aligned.

Talk to an Implementation Advisor Get the Regulated Implementation Readiness Checklist

What makes medical and regulated implementations different

This space is not one set of rules. The implementation approach has to match what you sell, where you sell it, and how you are regulated.

1) Different products have different traceability obligations
Medical devices

Unique Device Identification (UDI) on labels, and device identifier data submitted to FDA's Global Unique Device Identification Database (GUDID).

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Prescription drugs

DSCSA drives interoperable, electronic, package-level tracing as drugs move through the US supply chain, with FDA compliance policies and waivers affecting how enforcement has been phased.

2) Validation and audit readiness are part of the build

Part 11 includes expectations like validated systems, the ability to produce complete copies of records for inspection, and controls such as audit trails and access controls for systems managing covered electronic records.

3) Quality and supply chain are tightly coupled

Quarantine, release, disposition, complaints, recalls, training, and deviation handling are not side processes. They influence inventory status, what can ship, and what cannot.

4) Legacy replacement is rarely a clean cutover

Parallel operations are common because historical records, validated reports, and exception workflows live in the legacy environment. Decommissioning requires controlled retention and continued audit accessibility. "System of record" rules must be explicit during coexistence.

5) Integrations are a compliance risk when they are not owned

Regulated networks often have dense EDI and API connections to 3PLs, carriers, serialization and labeling solutions, customer portals, and quality platforms. Weak monitoring and unclear ownership create silent failures.

6) Global requirements add real dates and external dependencies

If you operate in the EU medical device space, the European Commission states that as of 28 May 2026 the first four EUDAMED modules are mandatory to use. For US medical device manufacturers, FDA states it will begin enforcing QMSR on February 2, 2026.

The most common pitfalls (and what they look like in the real world)
Pitfall 1

The system goes live, but the evidence is not defensible

  • Requirements and controls are not documented clearly enough to trace through testing
  • Testing proves transactions, but not controlled operation and exception handling
  • Role based access and audit trail expectations are not designed into workflows that matter
  • SOPs do not match what users actually do, so reality drifts from documentation
Symptom
"Operations are running, but we cannot walk an auditor through it cleanly."
Pitfall 2

Legacy systems are "replaced" but not actually retired

  • The legacy system remains the real source of truth for batch history, quality evidence, or reporting
  • Exceptions continue to be handled in the old workflow because the new one is not engineered
  • Migration focuses on what moves, not what must remain accessible for audit and investigations
  • Parallel runs happen without clear reconciliation rules
Symptom
"We are live, but we still need the old system to stay safe in an audit."
Pitfall 3

Traceability is treated like a data mapping exercise

  • UDI and device identifier data are not governed end to end for devices
  • Lot/serial, expiry, returns verification, and recall readiness are not rehearsed
  • For pharma networks, tracing workflows are not built around how DSCSA expectations show up operationally across trading partners
Symptom
"We can ship, but we cannot prove chain of custody quickly."
Pitfall 4

Holds, release, and disposition workflows are not enforced

  • Quarantine and released inventory are not separated cleanly by status and location rules
  • Sampling and inspection steps get bypassed under pressure
  • Integrations allow inventory to move without proper release confirmation
Symptom
"Good inventory gets stuck, and risky inventory moves."
Pitfall 5

EDI and API integrations are fragile under exception volume

  • Retries create duplicates because idempotency was not designed
  • Status definitions differ across OMS, WMS, and 3PL systems
  • Critical integrations lack monitoring, alerting, and clear ownership
Symptom
"Systems disagree, and nobody trusts what is true."

Where we engage (pick the support you actually need)

Typical transition and digitization timelines

Regulated programs often take longer because validation evidence, documentation, and controlled transitions are part of the work. Part 11 controls include validated systems and record inspection needs, which affects both design and test approach.

  • Discovery and current state mapping 3–8 weeks
  • Future state design and fit gap 6–12 weeks
  • Build, configuration, and integrations (ERP, WMS, TMS, OMS, EDI, APIs) 10–24+ weeks
  • Validation and controlled testing evidence (risk based) 6–16+ weeks
  • Cutover planning and rehearsals 3–8 weeks
  • Go live and hypercare stabilization 6–16 weeks
  • Optimization and control maturity 12–36+ weeks
Callout:
Many regulated cutovers require a planned coexistence window, with explicit system of record rules, reconciliations, and a controlled decommission plan that preserves audit accessibility.
M&A focus areas (what breaks first)

Regulated M&A tends to break where quality evidence, traceability, and systems converge.

  • Conflicting master data and identification standards (UDI and device identifier governance for devices)
  • Different release, quarantine, and disposition policies
  • Multiple integrations and multiple "truths" after consolidation
  • Legacy evidence split across companies, systems, and 3PLs, making investigations and recalls harder
  • EU readiness differences, including EUDAMED mandatory modules starting 28 May 2026
What "good" looks like (measurable outcomes)
  • Traceability questions can be answered quickly, with consistent records and clear ownership
  • Holds, releases, and disposition are enforced and visible
  • Exceptions are routed and resolved with a daily cadence that produces evidence, not confusion
  • Integrations are stable, monitored, and resilient under failure scenarios
  • Legacy systems are decommissioned in a controlled way, without losing audit defensibility
How we work (simple, execution forward)
1
Assess
Current state, risk, readiness, control gaps, integration inventory, legacy dependencies
2
Align
Operating model, RACI, critical flows, quality touchpoints, and success metrics
3
Plan
Validation approach, testing strategy, coexistence rules, cutover plan, and contingency paths
4
Execute
Controlled go live support, triage cadence, integration monitoring, issue burn down
5
Stabilize
Reinforce controls, mature reporting, decommission legacy safely, and build the optimization roadmap
Deliverables you can expect
  • Regulated implementation risk and readiness scorecard (ops, data, integrations, testing, cutover, controls)
  • Requirements and controls package (what must be true for operations and audit readiness)
  • Validation support artifacts (risk based approach, test evidence structure, traceability of requirements to tests)
  • Traceability model and master data requirements (UDI and GUDID readiness for devices, and traceability workflows as applicable)
  • EDI and API integration inventory (owners, SLAs, retries, monitoring, and data ownership)
  • Legacy dependency map (reports, evidence, integrations, and workflows that still rely on legacy systems)
  • Coexistence and system of record rules, plus reconciliation playbooks
  • Controlled decommission plan (retention, audit accessibility, retirement sequencing)
  • Cutover plan, rehearsal scripts, and Day 1 and Day 2 playbooks
  • Stabilization command center model (cadence, exception routing, audit ready reporting)

Looking for more?

Planning a rollout? Recovering from turbulence?

If you are implementing or stabilizing regulated operations, or unifying organizations after an acquisition, we can help reduce risk and protect continuity while keeping controls intact.

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