Quality

21 CFR Part 11 and EU Annex 11 Compliance

21 CFR Part 11 and EU GMP Annex 11 set expectations for electronic records, electronic signatures, and computerized system controls. Viltis helps map systems, close control gaps, and align validation…

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Practice areaQuality
Typical needCapability support for regulated programs
EngagementConsulting, augmentation, or hybrid
Related pathQuality

The client situation

When organizations typically need this capability.
  • Introducing new GxP software or cloud platforms
  • Inspection findings on electronic records
  • Data integrity remediation programs
  • Hybrid paper/electronic process transitions

How Viltis helps

Structured support, end to end

  1. 01

    Step 1

    System inventories and risk ranking

  2. 02

    Step 2

    Part 11 / Annex 11 assessments

  3. 03

    Step 3

    Procedures for e-signature and audit trails

  4. 04

    Step 4

    CSV/CSA linkage and revalidation decisions

21 CFR Part 11 and EU GMP Annex 11 set expectations for electronic records, electronic signatures, and computerized system controls. Viltis helps map systems, close control gaps, and align validation evidence with risk and intended use.

Typical deliverables

What engagement can produce

Compliance assessment report

Remediation roadmap

Policy and SOP updates

Evidence map for inspections

FAQ

Common questions

Is this the same as CSV?

Part 11/Annex 11 focus on electronic record controls; CSV/CSA addresses system validation. Viltis commonly delivers both together for complete digital quality governance.

Related proof

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Viltis provides consulting and resourcing for compliance readiness and operational support. We do not issue certifications or act as an accredited certification body.

Need support with 21 CFR Part 11 and EU Annex 11 Compliance?

Discuss this requirement with our team - scope, timeline, and delivery model.

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