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Terms & Conditions

 


Provider: OZQA ApS (“OZQA”)

These Terms & Conditions (“Terms”) apply to all implementation services and the Compliance Support Membership offered by OZQA ApS. By purchasing or using these services, the Client agrees to the following terms.

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1. Definitions

“Client” – The purchasing company or individual using OZQA services.
“Implementation Services” – The Basic, Plus, and Premium packages for SOP adjustments.
“Compliance Support Membership” – The monthly membership service providing ongoing QA and compliance support.
“Templates” – SOPs, log forms, or QMS documents purchased separately from OZQA.
“QMS” – Quality Management System.

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2. Scope of Services

2.1 Implementation Service Packages (all tiers)

Implementation Services cover the adjustment of SOP templates purchased by the Client.
Adjustment includes:

  • Adding company-specific details (name, structure, roles)

  • Making minor workflow changes

  • Ensuring consistency across selected SOPs

  • QA review and quality check

  • Delivery in Word/PDF

Implementation does not include writing new SOPs, heavy customization, regulatory submissions, or full QMS setup beyond the included templates.

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2.2 Basic Implementation (1–3 SOP adjustments)

Includes:

  • Adjustment of 1–3 SOPs

  • One alignment call

  • QA review & quality check

  • Email support for clarification questions

Valid until canceled (one-time service).

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2.3 Plus Implementation (4–8 SOP adjustments)

Includes:

  • Adjustment of 4–8 SOPs

  • Two alignment calls

  • QA review & quality check

  • Email support for clarifications

  • Support integrating adapted SOPs into Client’s QMS

Valid until canceled (one-time service).

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2.4 Premium Implementation (9–13 SOP adjustments)

Includes:

  • Adjustment of 9–13 SOPs

  • Multiple alignment calls as needed

  • QA review & quality check

  • Priority email support during the implementation period

  • Support ensuring interactions between SOPs are consistent

Valid until canceled (one-time service).

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3. Compliance Support Membership 

The Compliance Support Membership provides ongoing QA and compliance assistance for companies that have purchased templates or implementation services.

The Membership includes:

  • 24-hour AI QA support

  • Prioritized QA email responses

  • One (1) online QA meeting per month (up to 60 minutes)

  • Implementation guides and how-to materials

  • Access to new tools and updates

  • Discounts on additional SOP adjustments (where applicable)

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The Membership does not include:

  • Creation of new SOPs

  • Extensive consultancy beyond the 1 included hour

  • Regulatory submissions (IND, CTA, etc.)

  • Vendor audits or CRO/CMO qualification

  • Full QMS redesign

  • On-site work

Membership is billed monthly and runs for 12 months, renewing automatically unless canceled with 14 days’ notice.

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4. Exclusions (all services)

Unless specifically included, OZQA services do not cover:

  • Writing or developing new SOPs

  • On-site work

  • Inspection readiness audits (unless purchased separately)

  • Legal, regulatory, or compliance liability assumption

  • Vendor audits or qualification

  • QMS operation or maintenance after implementation

  • Ongoing document updates (except via Membership)

These may be purchased separately.

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5. Client Responsibilities

The Client is responsible for:

  • Providing accurate and timely information for SOP adjustments

  • Ensuring internal review and approval of adapted SOPs

  • Implementing the QMS internally

  • Training staff and maintaining documentation

  • Responding to OZQA when information is required

  • Maintaining compliance after service delivery

OZQA is not responsible for failures caused by Client’s lack of implementation or incorrect use of templates.

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6. Intellectual Property Rights

All SOPs, templates, guides, training materials, and documentation remain intellectual property of OZQA.

Client receives a non-exclusive, non-transferable internal-use licence.
Client may not:

  • Resell, distribute, or publish materials

  • Share materials with external parties (except regulators)

  • Create derivative works for commercial use

Breach of this clause results in immediate termination of services without refund.

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7. Payment Terms

  • All Implementation Services must be paid upfront.

  • Compliance Support Membership is billed monthly.

  • Prices are exclusive of VAT (unless stated).

  • No refunds for partially completed services or unused months.

Late payments may result in suspension of services.

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8. Cancellation & Termination

8.1 Implementation Services

These are one-time services. Once started, they cannot be refunded, even if not used by Client.

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8.2 Compliance Support Membership

  • Can be canceled with 14 days’ notice before the next billing cycle

  • No refunds for partial months

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8.3 Termination by OZQA

OZQA may terminate services immediately if:

  • Client violates Terms

  • Client redistributes proprietary materials

  • Client acts unlawfully or unethically

No refunds apply.

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9. Liability

OZQA provides services based on regulatory best practices but cannot guarantee inspection outcomes, approvals, or compliance status.
OZQA’s total liability is limited to the amount paid by Client for the specific service.

Client is fully responsible for operating and maintaining their own QMS.

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10. Governing Law

These Terms are governed by Danish law.
Exclusive jurisdiction: Copenhagen City Court.

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11. Acceptance of Terms

By purchasing any Implementation Service or Membership, Client confirms acceptance of these Terms in full.

Hvis du ønsker, laver jeg også:
✔ Kort udgave til checkout
✔ Visuel sammenligningstabel (Basic / Plus / Premium / Membership)
✔ Refusion- og annulleringspolitik
✔ Terms of Use på selve SOP-downloads

Bare sig til — så laver jeg dem i samme stil.

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