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Services

Four services. One delivery model.

Everything Aperigon offers is built on the same methodology, the same senior team, and the same commitment to inspection-ready output. The services are entry points; the operating model doesn't change between them.

01 — Implementation

Full-lifecycle Dynamics 365.

Full-lifecycle Microsoft Dynamics 365 implementations can be completed in as little as 16 weeks depending on scope and module count.  Validation deliverables are produced inside the implementation, not after, reducing the total deployment time by months.

What you receive at go-live: a configured, integrated, tested Dynamics 365 environment — and a complete validation package: validation plan, URS, FRS, configuration specification, traceability matrix, IQ protocol and report, OQ protocol and report, PQ protocol and report, validation summary report, training records.

How we scope: phases with named deliverables and acceptance criteria written into the SOW. If a phase misses its acceptance criteria, we own the gap.

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02 — Computer System Validation

CSV written by the people who configured the system.

Most CSV engagements suffer from the same problem: the validation team is reverse-engineering a configuration they didn't design. The result is documentation that's technically compliant but evidentially thin — and that's where auditors find purchase.

Aperigon's validation team and configuration team are the same team. The traceability matrix isn't a reconstruction. It's the design document.

Frameworks we apply: 21 CFR Part 11, EU GMP Annex 11, GAMP 5 Second Edition, and FDA's 2025 final CSA guidance.

Available standalone: if you've already implemented Dynamics 365 and need validation remediation, we run a gap assessment first and propose a defined-scope remediation engagement.

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03 — Industry extensions

The configurations regulated companies actually need.

Standard Dynamics 365 covers more than most generalists realize, but there are configurations every Life Sciences company needs that are easy to get wrong. We've codified them.

  • Lot and serial traceability — end-to-end lot genealogy from raw material through finished good, with backwards and forwards trace, expiry handling, hold/release status, and the audit trail to defend it.
  • EBR/eBPR integration patterns — defined integration patterns to electronic batch record systems and MES platforms.
  • QMS integration — integration patterns to the major Life Sciences quality management platforms.
  • Regulated document handling — configured retention, access controls, audit logging, and electronic signature workflows aligned to Part 11 and Annex 11.
  • Electronic signatures and audit trails — Part 11-compliant e-signature configuration with reason-for-change capture, audit trail review workflows, and the SOPs to wrap them.
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04 — Managed services

For a system that has to stay validated.

A validated system is not a one-time event. Every Microsoft release wave changes something. Every regulatory revision changes something. Every business change changes something. Most managed-service contracts ignore all three. Ours doesn't.

  • Tier 2/3 application support with named senior practitioners.
  • Monthly release management with regression validation against your validated baseline.
  • Quarterly regulatory horizon scan covering FDA, EMA, MHRA, and PIC/S updates relevant to your configuration.
  • Annual validation refresh and periodic review.
  • Defined SLAs for incident response, request fulfillment, and release windows.

How we scope: a defined monthly scope of work tied to your environment complexity and SLA tier. Six-month minimum. Regulatory horizon work is part of the base scope, not a surprise change order.

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