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Branche · Pharma & Life Sciences

DecisionOS for Pharma and Life Sciences

Pharma and life sciences operate under some of the strictest regulation in the world: EU GMP Annex 11 for computerised systems, 21 CFR Part 11 for FDA-relevant workloads, EU GDP for distribution, GCP for clinical trials. Plus NIS2 across all of it. Every IT procurement must be validated (CSV/CSA) and documented audit-defensibly. DecisionOS produces the decision memo that supports validation preparation.

TL;DR

Pharma IT is regulated IT. Validation (CSV/CSA) and audit trail are not optional. The decision memo is the mandatory front-end documentation.

Regulatorik im Überblick

EU GMP Annex 1121 CFR Part 11 (FDA)ICH Q9/Q10NIS2GDPREU AI ActEMA reflection paper on AI

Regulatory context

EU GMP Annex 11 is the EU guideline for computerised systems in pharmaceutical manufacturing. Requirements: validation, data integrity (ALCOA+ principles), access controls, audit trail, backup, change control, periodic review.

21 CFR Part 11 is the US counterpart for FDA-relevant workloads. Duties: validated systems, audit trails, electronic signatures, access controls. Companies distributing FDA-approved products almost always have Part 11 in scope.

ICH Q9/Q10 focus on quality risk management. NIS2 adds cyber resilience. The EU AI Act introduces new classification duties for AI-assisted pharmacovigilance or clinical decision support.

Typische Entscheidungen

EDR / XDR selection

IAM / IGA / PAM

Sovereign cloud migration

ERP modernisation

Backup and DR

M365 vs Google Workspace

Dealbreaker (nicht verhandelbar)

  • GxP validation capability

    Vendor must provide validation packages (IQ/OQ/PQ) or CSA-compliant risk-based evidence.

  • Audit trail and 21 CFR Part 11 conformity

    Mandatory for FDA-relevant workloads. Tamper evidence, timestamps, user binding.

  • EU data residency with BSI C5

    Patient and research data are highly protected. EU-only data flow.

  • Supply-chain compliance (CDMO, CRO)

    Suppliers are part of the regulated quality system.

Where DecisionOS plugs in

The DecisionOS memo represents the structured vendor and tool selection that sits upstream of validation.

Mapping: criteria against Annex 11 clause by clause, dealbreakers against Part 11 requirements, stakeholder alignment across Quality, IT, Compliance, Validation, Production. Versioning in the sense of Annex 11 clause 10.

Typical use cases

LIMS or ELN selection with GxP validation.

Cloud migration of QMS or MES under Annex 11 conformity.

AI-assisted pharmacovigilance: EU AI Act classification and FRIA.

CDMO and CRO vendor selection with documented quality compliance.

Hosting and data sovereignty

DecisionOS is hosted in Germany on Hetzner, EU-only data flow, Art. 28 GDPR data processing agreement. Suited as a decision layer for IT decisions; sensitive patient data typically stays in LIMS/EHR.

FAQ

What is the difference between CSV and CSA?

Computer System Validation (CSV) is the classical IQ/OQ/PQ-driven validation approach. Computer Software Assurance (CSA) is the newer FDA-preferred risk-based approach (2022): more assessment, fewer test scripts, more critical thinking. Both exist in parallel; many manufacturers are gradually migrating from CSV to CSA.

Are cloud LIMS vendors GxP-validatable?

Yes, but only if the vendor provides validation packages or runs a dedicated GxP-ready programme. Check: quality manual, change-control documentation, audit-trail depth, backup validation, GDPR Art. 28 data processing agreement. Mature vendors: LabVantage, STARLIMS, Benchling, LabWare, Sapio.

How do NIS2 and GMP relate?

GMP focuses on product quality, NIS2 on IT resilience. Pharma companies above 50 staff / 10 M EUR turnover fall under NIS2 as important entities. NIS2 duties apply in addition to GMP quality logic. Obligations overlap partially (backup, access control) but are not identical.

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