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SOPs & validation docs

SOP and validation-document development

Inspectors read your SOP and then watch the process. If those two stories differ, you have a finding. CliniGene develops controlled documents from interviews and the real system, not from a generic template dump. AI produces the structured first draft and a cross-SOP conflict list. Your process owner and QA revise; document control makes it effective.

Contact us about this Email hello@clini-gene.com

The problem this process is built for

SOPs are often copied from a previous company or a vendor and never walked. Training is a read-and-sign. The form in the QMS does not match the fields in Vault. A validation plan still names a server that was retired.

Validation documents have the same failure mode: they describe a hoped-for system. CSA and GAMP expect intended use and risk. That only works if the VP, RA, protocols, and report use the same function names as the SOP and the configuration workbook.

AI is a draft engine and a consistency checker. It must not publish into the QMS. Your document controller owns effective dates and training launch.

What this has to survive

An inspector reads the SOP, then watches the process or opens Vault. Those two stories must match — including the form fields and the validation report’s system name.

Standards we score against

  • Your document-control SOP (numbering, review, training, periodic review)
  • Linked process SOPs (deviation, change control, training, data integrity)
  • GCP / CSV / CSA / TMF procedures this document must not contradict
  • Your validation templates (VP, RA, IQ/OQ/PQ, RTM, VSR)
  • ALCOA+ language where records are created

Where teams get stuck

  • Orphan forms — a form with no parent SOP
  • Two SOPs that assign the same approval to different roles
  • Validation plan that does not match the SOP’s system name
  • Periodic review overdue; no one knows what changed
  • Training quiz that tests the old procedure

Who it is for

Document control, process owners, quality authors, and validation writers who need inspectable procedures and a clean validation document set.

What AI does — and does not do

On document work, AI drafts in your template and lists cross-SOP and validation-name conflicts. The process owner must recognize the walkthrough. Document control publishes. AI drafts maps, flags, first-pass language, and punch lists. A named specialist accepts, edits, or dismisses every official finding. AI does not sign a quality record, approve a vendor, freeze Vault, or speak in an inspection.

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

When to start this process

Start when Vault or another system went live and the SOP still describes a share drive, when two SOPs name different approvers for the same step, or when a validation plan still names a retired server.

A family of 8–12 SOPs is a backlog with owners — not a weekend AI job. We will say so in week 0.

What this is not

  • Clicking Effective in your QMS unless your SOP and the engagement allow it
  • Inventing a process the room has not walked
  • Training execution (we draft materials; you run the training SOP)
  • Regulatory legal opinions in SOP text
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.

Inventory and orphans

List SOP/WI/form/validation docs, owners, and next review date. Flag forms without a parent and titles that collide.

Process map from the room

Interview + screenshots → trigger, roles, systems, records, exceptions. This map is what the SOP must say. If the room cannot agree, we do not paper over it.

Template-faithful draft

Purpose, scope, responsibilities, procedure, records, references — in your header. Cross-references are placeholders until the owner confirms numbers.

Conflict pass

Compare the draft to sibling SOPs and to the validation workbook. “QA approves in SOP-12; SOP-19 says the system owner approves.” Listed, not silently picked.

Validation set alignment

VP, RA, protocol, and report drafts share one function list. AI checks the names match. Your validation lead still owns the science of the tests.

Effective packet

Change-history paragraph, training outline, quiz items if you use them. Document control runs the workflow.

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

Contact form Email the team
End-to-end process

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

  1. 1

    Scope the document set

    Which SOP family or which validation pack. Name the owner and QA reviewer before drafting.

  2. 2

    Walk the process

    Live system or last inspection path. Record the ugly exceptions; they belong in the SOP or they will become deviations.

  3. 3

    Inventory and map

    AI inventory + process map. Owner confirms “this is how we work” or we stop and fix the process first.

  4. 4

    Draft

    SOP/WI/form or VP/RA/protocol/report in your template.

  5. 5

    Technical and QA review

    Comment log. AI can cluster comments; resolution is human. We keep the log for the approval packet.

  6. 6

    Cross-check

    Sibling SOPs, validation names, form fields vs. procedure steps.

  7. 7

    Training and change history

    What changed and who must be trained before effective.

  8. 8

    Handoff to document control

    You publish. We do not click Effective in your QMS unless that is explicitly in the engagement and your SOP allows it.

What a typical engagement looks like

Setting. Typical: TMF SOP + WI + file-note form out of date after a Vault go-live; validation report still names the old share drive.

What we do. Walk the Vault process, draft SOP/WI/form, conflict-check against deviation and training SOPs, align the validation summary to the new intended use, prepare training packet.

What you can show. The SOP, the vault, and the validation report tell the same story.

Time

A single SOP + WI + form is often 3–6 weeks including reviews. A validation document set tracks the system project. A family of 8–12 SOPs is a program with a backlog, not a weekend AI job.

How a typical calendar runs

  1. Week 0. Scope the document set. Name owner and QA reviewer. Templates and current PDFs in.
  2. Week 1. Walk the process. Record exceptions. Inventory orphans and colliding titles.
  3. Week 2. Process map confirmed: “this is how we work.” If not, we stop and fix the process first.
  4. Week 2–4. Draft SOP/WI/form or VP/RA/protocol/report. Conflict pass against sibling SOPs and the validation workbook.
  5. Week 4–6. Comment log, training outline, change history. Handoff to document control.

What we need from you

  • Document-control SOP and templates
  • Current SOP/WI/form PDFs and the QMS list
  • Access to watch the process (or a detailed interview)
  • Validation templates and last approved pack if revising those

You receive

  • Process map and document inventory (including orphans)
  • SOP/WI/form or validation-document drafts in your template
  • Cross-SOP / cross-pack consistency log
  • Comment-resolution log for the approval packet
  • Training outline and change-history paragraph

Questions we hear first

Will the SOP be written only by AI?
No. AI drafts. The owner must recognize their process. If they do not, we rewrite from the walkthrough.
Do you train staff?
We can draft materials. Training execution follows your training SOP.
Can you write in our QMS editor?
If you grant controlled author access under your SOP. Otherwise we deliver in your Word/template and you upload.
Do you write only SOPs, or also validation plans?
Both. SOP/WI/form families and VP/RA/protocol/RTM/report sets. They must share function and system names.
What if the process owner disagrees with the walkthrough?
We do not paper over it. Either the process changes or the document waits. An SOP nobody recognizes is an inspection finding waiting to happen.
Can drafts stay in Word until we are ready for the QMS?
Yes. That is the default unless you grant controlled author access under your document-control SOP.

Start with SOP and validation-document development

Email hello@clini-gene.com or use the form. Mention SOP and validation-document development so we route it correctly.

hello@clini-gene.com

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Talk with us about SOP and validation-document development

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.

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

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