Part 11 / CSA Readiness Assessment

A fixed-scope assessment of where your computer system validation stands against 21 CFR Part 11 and the FDA’s current Computer Software Assurance (CSA) expectations — ending in a board-ready gap report and a prioritized action plan.


Scope

What we assess

A focused review of the controls inspectors test and the validation model FDA now expects.

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21 CFR Part 11

Electronic records and signatures — audit trails, access, e-sig integrity, controls and SOPs.

CSA maturity

How far your validation has moved from document-heavy CSV to risk-based assurance.

System inventory & risk

Your GxP systems classified by intended use and process risk.

Validation deliverables

Are your plans, protocols and reports right-sized and defensible?

Gap & exposure rating

Findings rated by inspection exposure and patient/product risk.

Prioritized roadmap

A sequenced plan: quick wins first, structural fixes scoped.

Deliverables

What you receive

  • Part 11 controls gap analysis
  • CSA maturity scorecard
  • GxP system inventory & risk classification
  • Findings rated by exposure
  • Prioritized, sequenced remediation roadmap
  • Effort estimates for each item
  • Alignment to FDA CSA final guidance (Feb 2026)
  • Board-ready summary report

The low-risk way to start. A defined assessment that scopes the work and quantifies exposure before any larger validation commitment.

How it works

Exposure to action plan in weeks

STEP 01

Scope

Agree systems and timeframe in review.

STEP 02

Assess

Document review, walkthroughs, control testing.

STEP 03

Report

Risk-rated findings and gap report.

STEP 04

Plan

Prioritized roadmap and next-step scoping.

Why SQA Solution

Why teams choose us

Current, not 2022

Aligned to the FDA CSA final guidance finalized Sept 2025 and updated Feb 3, 2026 (QMSR-aligned) — not the superseded draft.

Fixed-fee, transparent scope

A defined deliverable and timeline — no open-ended hourly billing.

Risk-based

We focus on real exposure, not paperwork volume.

Senior consultants

Inspection-grade rigor from named practitioners.

Fixed-fee, transparent scope

A defined engagement with a defined price and timeline — no open-ended hourly billing. Scope scales to your systems and goals.

Get a scoped quote

Know where you stand before your next inspection

Tell us how many systems are in scope. We’ll come back with a fixed-fee assessment plan.

Request a Quote
Some of our clients
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Case Studies
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SQA Solution's Approach to 21 CFR Part 11 Compliance in a Global Healthcare Corporation

A global healthcare corporation faced significant challenges in complying with 21 CFR Part 11, especially section 11.10

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    Strategic SOP Development for Enhanced Infrastructure and Compliance for BioPharma

    Developing comprehensive SOPs in a biopharmaceutical context is fundamental for ensuring regulatory compliance, and maintaining high standards of quality and safety …

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      Comprehensive API Testing for a Leading Credit Manager in Commercial Real Estate Lending

      Before engaging our services, the client faced significant challenges in ensuring the reliability, security, and overall quality of their API functionalities …

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        SAP S/4 HANA GxP Compliance and Validation Project

        The objective is to align the SAP S/4 HANA system of a leading biopharma
        company with the stringent requirements of GxP regulations and
        21 CFR Part 11 …

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          SQA Solution Quality Systems and Compliance Consultant at a Biotechnology Company

          The consultant’s role is pivotal in ensuring the compliance of computerized systems with regulatory standards and internal policies.

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            Optimizing Software Quality and Performance for a Leading Multi-Channel Retailer

            The retailer required a robust software infrastructure to ensure seamless online shopping experiences and operational efficiency …

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