Services / Quality Systems

Quality Systems

Quality Management Systems

We help emerging life-sciences companies establish and improve practical, scalable quality systems.

Schedule a Consultation Email hello@clini-gene.com

We help emerging life-sciences companies establish and improve practical, scalable quality systems.

Services Include

  • Quality manual development
  • SOP, policy, form, and template creation
  • Document-control processes
  • Change-control management
  • Deviation and investigation support
  • CAPA development and effectiveness checks
  • Training program development
  • Vendor qualification and oversight
  • Audit preparation
  • Inspection-readiness assessments
  • Quality metrics and management review
  • Data-integrity assessments
  • Remediation planning
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How we take this further

Inspectors read your SOP and then watch the process. If those two stories differ, you have a finding. Emerging companies often inherit templates that do not match how work is done, or they have no controlled process for change, deviation, CAPA, training, or vendors.

CliniGene develops practical quality processes, SOPs, templates, change controls, CAPAs, training programs, and audit-readiness plans scaled to organizational maturity.

Standards we score against

  • Your document-control SOP (or the one we help you stand up)
  • Linked process SOPs: deviation, change control, training, data integrity, vendor qualification
  • Applicable GxP expectations for your stage (preclinical, clinical, commercial-path)
  • ALCOA+ language where records are created

Where teams get stuck

  • No quality manual that matches the company you are today
  • Orphan forms — a form with no parent SOP
  • CAPAs closed on status, not on new evidence
  • Vendor files that will not survive a sponsor or authority ask
  • Training that is read-and-sign against an outdated procedure

Who it is for

Emerging biotechnology and pharmaceutical companies, virtual life-sciences companies, and clinical-stage organizations that need a quality system they can actually run — not a binder copied from a larger enterprise.

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.

Inventory and orphans

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

Process map from the room

Interview plus screenshots → trigger, roles, systems, records, exceptions. If the room cannot agree, we do not paper over it.

Template-faithful draft

Purpose, scope, responsibilities, procedure, records, references — in your header.

Conflict pass

Compare drafts to sibling SOPs and to the systems people actually use.

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

    Scope the quality system

    Which processes must exist for your stage: document control, change, deviation, CAPA, training, vendors, data integrity, management review.

  2. 2

    Walk the work

    How change, deviations, and documents actually move today.

  3. 3

    Write the manual and the family

    Quality manual, SOPs, policies, forms, and templates that match the walkthrough.

  4. 4

    Stand up document and change control

    Numbering, review, training launch, and how a change is assessed.

  5. 5

    Support deviations, investigations, and CAPA

    Language, effectiveness checks, and owners — decisions stay with your Quality unit.

  6. 6

    Qualify vendors and prepare for audit

    Tiered files, query lists, and an inspection-readiness view of the QMS.

  7. 7

    Metrics and management review

    A small set of quality metrics leadership can actually use.

  8. 8

    Remediate what the assessment found

    A dated plan, not a finding register that never moves.

What a typical engagement looks like

Setting. Typical: clinical-stage or virtual biotech standing up a first practical QMS, or cleaning a copied SOP set before a financing or partner audit.

What we do. Quality manual, core SOP family, change and CAPA path, training outline, vendor file approach, and a readiness plan.

What you can show. The SOP, the system, and the story leadership tells are the same story.

Time

A core SOP family plus manual for an emerging company is often 6–12 weeks including reviews. A single process (change, CAPA, vendors) can be shorter. A full remediation is scoped to the finding list.

What we need from you

  • Current SOP/policy/form set if any
  • Document-control templates you want to keep
  • Access to watch the process or a detailed interview
  • Who may approve controlled documents

You receive

  • Quality manual development
  • SOP, policy, form, and template creation
  • Document-control processes
  • Change-control management support
  • Deviation and investigation support
  • CAPA development and effectiveness checks
  • Training program development
  • Vendor qualification and oversight support
  • Audit preparation and inspection-readiness assessments
  • Quality metrics and management review
  • Data-integrity assessments
  • Remediation planning

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 replace the Quality unit?
No. We develop processes and drafts. Your designated owners approve and remain accountable.

Start with Quality Management Systems

Email hello@clini-gene.com or use the form. Mention Quality Management Systems so we route it correctly.

hello@clini-gene.com

Schedule a Consultation Email hello@clini-gene.com

Talk with us about Quality Management Systems

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.

See Privacy Policy. Services and deliverables are subject to customer review and approval.

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