Services / CSV and CSA

CSV and CSA

Computer System Validation and Computer Software Assurance

CliniGene provides risk-based validation services for GxP applications and technology changes.

Schedule a Consultation Email hello@clini-gene.com

CliniGene provides risk-based validation services for GxP applications and technology changes.

Our documentation is aligned with the system’s intended use, applicable procedures, identified risks, and the customer’s quality framework.

Our documentation is aligned with the system’s intended use, applicable procedures, identified risks, and the customer’s quality framework.

Deliverables May Include

  • System impact assessment
  • GxP assessment
  • Electronic records and signatures assessment
  • Validation plan
  • User requirements specification
  • Functional or configuration specification
  • Risk assessment
  • Supplier assessment
  • Verification or UAT protocol
  • Requirements traceability matrix
  • Deviation documentation
  • Validation summary report
  • Production-verification checklist
  • Periodic review
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How we take this further

Traditional CSV often tests everything the same way. Hundreds of scripted steps burn the calendar and still miss the one interface that can silently drop a lab value. CSA was issued so you could put rigor where risk is, and stop performing theater where it is not — but only if you write the rationale down.

Teams get stuck in two opposite errors: treating CSA as permission to barely test, or still IQ/OQ/PQ every click. The work is the intended-use statement, the risk table, and the documented split.

AI helps because vendor manuals, release notes, and your last validation pack are long. Drafting failure modes and delta-validation plans is language work. Assigning residual risk is not.

Standards we score against

  • FDA Computer Software Assurance for Production and Quality System Software (2022 guidance)
  • GAMP 5 2nd edition — categories, risk, supplier assessment
  • 21 CFR Part 11, EU Annex 11, and your Part 11 SOP
  • ALCOA+ / data-integrity policy
  • Your CSV/CSA SOP and periodic-review procedure

Where teams get stuck

  • No intended-use paragraph; validation scope is “the whole system”
  • GAMP category argued in email, not in the validation plan
  • Same scripted depth for a report color and for an e-signature
  • Vendor validation package unread; everything re-tested
  • Periodic review is a calendar reminder with no release diff

Who it is for

CSV/CSA leads, quality systems, IT validation, and system owners for EDC, eTMF, CTMS, QMS, LIMS, safety, LMS, and GxP SaaS — including emerging companies that need proportionate evidence, not a copy-paste IQ/OQ/PQ for every screen.

What AI does — and does not do

AI supports analysis, consistency, traceability, and document preparation. Qualified professionals review every regulated deliverable, and customers retain final approval authority. AI-generated content remains a draft until it has been reviewed and approved by an authorized individual.

Questions on fit? hello@clini-gene.com or the contact form.

AI in this process

How the model is used, layer by layer

Each layer has a human gate. AI does not write the official quality record.

Intended-use draft

From SOPs and architecture notes, AI proposes who uses the system, on which GxP records, and what a wrong result would do. You edit this until it is boring and true.

Impact and GxP assessment

System impact, GxP determination, and electronic records and signatures considerations are drafted for specialist review.

Risk scenarios

Failure modes against safety, product quality, and data integrity. Each function gets a suggested assurance type: vendor evidence, automated test, unscripted, or scripted protocol.

Protocol and evidence index

Verification or UAT steps are drafted where risk and missing vendor evidence require them. The traceability matrix cites files, not “passed.”

Delta / periodic review

New vendor release notes or config exports are diffed against the last validated state. You decide what must be re-assured.

Want this process walked on your trial or system?

Send the study, Vault, vendor, or inspection window. We will say what we need and what a first pass looks like.

hello@clini-gene.com

Schedule a Consultation Email hello@clini-gene.com
End-to-end process

Step-by-step: from intake to re-check

  1. 1

    Name the system and the owner

    One system owner, one validation lead, one quality approver.

  2. 2

    Write intended use and impact

    Workshop plus draft. Include system impact, GxP assessment, and electronic records and signatures.

  3. 3

    Inventory functions and interfaces

    From manuals and admin screens. Mark GxP-critical vs. administrative.

  4. 4

    Risk and supplier assessment

    Walk high-impact functions. Assess the supplier pack instead of re-testing everything by habit.

  5. 5

    Document the assurance mix

    Vendor pack, automated tests, unscripted sessions, scripted verification — each with a why.

  6. 6

    Author and execute

    We draft the plan, URS, specifications, protocols, and RTM. Testers execute under your SOP. Deviations are classified by people.

  7. 7

    Report and release

    Summary report, production-verification checklist, residual risk listed.

  8. 8

    Park periodic review

    A checklist and a place for the next release notes so the next review is a diff, not a rewrite.

What a typical engagement looks like

Setting. Typical: SaaS eTMF or QMS already live, validation pack aging, CSA SOP newly approved, next vendor release in 90 days.

What we do. Rewrite intended use, rebuild the risk and assurance table, draft proportionate verification, and leave a periodic-review path.

What you can show. You can explain why a dashboard was assured via vendor evidence and why e-signature was scripted — in one table aligned to your quality framework.

Time

A single-system CSA reshaping of an existing pack is often 4–10 weeks. A net-new GAMP 5 validation tracks the system project. For a live Vault, pair this with Veeva Quality Systems services so each general release has a documented assurance path.

What we need from you

  • Current validation plan or last summary report if any
  • Vendor validation / assurance package and release notes
  • Architecture / data-flow and integration list
  • Part 11 and CSV/CSA SOPs and templates
  • Named CSA / validation owner

You receive

  • System impact assessment
  • GxP assessment
  • Electronic records and signatures assessment
  • Validation plan
  • User requirements specification
  • Functional or configuration specification
  • Risk assessment
  • Supplier assessment
  • Verification or UAT protocol
  • Requirements traceability matrix
  • Deviation documentation
  • Validation summary report
  • Production-verification checklist
  • Periodic review

Questions we hear first

Is CSA allowed instead of CSV?
CSA is how FDA describes assurance thinking for production and quality-system software. You still need a procedure, intended use, risk, and evidence. We do not tell you to skip validation.
Will AI execute tests?
No. People execute. AI drafts steps and indexes evidence.

Start with Computer System Validation and Computer Software Assurance

Email hello@clini-gene.com or use the form. Mention Computer System Validation and Computer Software Assurance so we route it correctly.

hello@clini-gene.com

Schedule a Consultation Email hello@clini-gene.com

Talk with us about Computer System Validation and Computer Software Assurance

Email hello@clini-gene.com or send this form. The process is already selected.

Tell us the trial, Vault, vendor, or inspection date and what “done” looks like.

Contact Form

Email hello@clini-gene.com if you prefer not to use the form.

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