PLANREFERENCE OUTLINE

Regulated Operating Model Establishment Plan

The sequencing plan a new regulated organisation builds its quality system against — scope and role determination, decision rights, the governing procedure set, the record model, qualification, and the operating history that has to exist before an inspection. Records decisions and owners, not compliance status.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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REGULATIONS MAPPED
ICH Q10ICH Q9(R1)21 CFR 21121 CFR Part 11EU GMP Annex 11
DOCUMENT TYPE
Plan
LAST UPDATED
August 2026
PURPOSE

The plan a new regulated organisation establishes its operating model against — recording what it has determined itself to be, who holds which decision rights, which procedures govern the rest, what evidence each activity must produce, and what has to be qualified before that evidence counts. It is a decision and sequencing record, not a statement of compliance status.

What's Inside

✓Scope determination — product type, target markets, and role in the value chain, with the decision owner recorded
✓Decision-rights table separating the quality decision from the commercial one
✓The governing procedure set every other procedure depends on, with owners and target dates
✓Record model — what each activity must produce, who reviews it, and where it is held
✓Qualification and validation scope for people, facilities, instruments, suppliers and computerised systems
✓Operating-history targets, because a system with no history is a set of documents
✓Open decisions and knowingly accepted risks

How to Use It

1Complete section 1 before committing to anything downstream — product type and value-chain role set every later obligation
2Fill the decision-rights table before writing a single procedure, so procedures can name roles that exist
3Define the record model before selecting software, so the record set is shaped by what must be proven rather than by what a tool does easily
4Treat qualification as a gate on the sections after it, not as work running alongside them
5Plan real calendar time for the operating-history section — it cannot be produced retrospectively
6Revisit at each funding, facility or market change; the plan is the record of decisions, so it changes when they do
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Purpose and scope
21. Scope determination — what the organisation is
32. Decision rights
43. Governing procedure set
54. Record model
65. Qualification and validation
76. Operating history
87. Open risks and determinations
AAppendix A — Appendix A — Approval
REGULATORY CONTEXT

ICH Q10 describes the pharmaceutical quality system and the management responsibilities this plan allocates; ICH Q9(R1) covers the risk basis for scoping qualification and validation effort. 21 CFR 211 and EU GMP Chapter 1 set expectations for the quality unit and its independence, and 21 CFR Part 11 with EU GMP Annex 11 govern electronic records and signatures where the record model is electronic. No authority prescribes the ORDER in which a company establishes these capabilities — the sequence here is SPEQ synthesis based on dependency, and the plan states that where it matters.

MAPPED STANDARDS
ICH Q10ICH Q9(R1)21 CFR 21121 CFR Part 11EU GMP Annex 11
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