Compliance Assessment

The assessment evaluates Part 11-relevant controls and expected behaviors (e.g., access control, audit trail, record integrity, electronic signatures) and frames shared responsibility between supplier technical controls and customer procedural controls.

• Objective: provide an assessor-authored evaluation artifact suitable for CSV review and audit discussion.
• Scope: Part 11 technical expectations as applicable to the assessed V5 Traceability configuration/version.
• Interpretation: Part 11 must be applied in context of the relevant predicate rule(s) and intended use.

This assessment is a supplier-focused compliance assessment artifact. It is not a regulatory determination and it is not a substitute for site validation activities or procedural controls.

• It is: independent assessment content to support supplier qualification and control evaluation.
• It is not: “FDA approval,” “certification,” or a blanket statement of compliance for every intended use.
• It is not: a replacement for your validation lifecycle execution (risk-based testing, SOPs, training, oversight).

CSV and QA teams typically use supplier assessments as structured inputs to vendor qualification and validation planning. Used correctly, this document supports clarity on control intent, responsibility allocation, and risk-based test focus.

• Supplier qualification: include as evidence in vendor assessment files and supplier audit packs.
• Validation planning: use as an input to URS/FS, risk assessment, and traceability matrix development.
• Audit readiness: reference for control design discussion, especially where “execution evidence” is expected.

Recommended practice is to align conclusions with your intended use, configured functions, and your procedural controls (e.g., access administration, periodic review, backup/restore, archiving, incident handling, training governance).

Part 11 expectations in operation depend on controlled procedures and governance. Regulated users should expect to define, document, and operate procedural controls appropriate to their environment and risk profile.

• Account provisioning/deprovisioning, role design, and periodic access review.
• Backup/restore, archival and retention, and controlled record export/handling.
• Training governance, signature authority/meaning, and procedural controls for deviations and exceptions.

The assessment was prepared by Dr. Robert McDowall, PhD (R.D. McDowall Limited). His profile notes over five decades of experience as an analytical chemist, including time in pharmaceutical companies and decades in consultancy, with extensive work in computer system validation (CSV). He is also described as a long-standing technical author/columnist, and a contributor to ISPE GAMP® guidance related to records and data integrity.

Reference profile: ISPE — Robert McDowall

Signed assessment PDF: SG-Systems-21CFRPart11.pdf

Document control note: if you cite this in qualification or validation documentation, record the version/date used and store the PDF in your controlled repository.