YOUR RECORD
Reading your record…
A SPEQ credential is not a certification.
- This is **not** a certification, licence, accreditation, or professional qualification, and SPEQ is not an accreditation body.
- It does **not** attest competence to perform any regulated task, and it does not substitute for employer training, role qualification, supervision, or professional judgment.
- It is **not** recognised by FDA, EMA, MHRA, or any other regulator, and it confers no regulatory status of any kind.
- It attests orientation to the material taught in the Foundations series only — not to GxP practice generally, and not to any discipline, industry, or role beyond it.
- It is issued on an unproctored, unsupervised assessment with a fixed item bank. Identity is linked to the account that took it and is not otherwise verified.
14 competencies are published against 48 role maps and 11 career pathways. 20 roles have a competency mapped to them; 28 do not. That is thin, and it is stated rather than implied away — a reader whose role is not here should know that before they go looking for it.
A mapping defect was corrected on 2026-09-01: four entries were filed against quality-assurance-associate while describing QC laboratory, CQV, clinical-operations and regulatory-affairs work — which left Laboratory Analyst (QC), the role whose whole job is trustworthy test data, with no competency at all. A parity test now checks each entry’s roles against the pathway the entry itself names, so a legal-but-wrong mapping fails the build.
The competency map
Competency is kept separate from content consumption. Each entry records what it means, how it is assessed, and — deliberately — what it does not indicate.
How to use this library
Filter to your level or your career pathway, then open a competency to read what it means, how it is assessed, and what it deliberately does not indicate.
A competency here describes what an entry is about. It is not a qualification, licence or certification, SPEQ assesses no attainment, and nothing on this page substitutes for employer training, supervision or professional judgement.
COMPLETE INDEX — ALL 14 COMPETENCY
Level comes from each competency's own record; the career pathway is derived from the roles it applies to, so it cannot drift from the role maps.
SPEQ Foundations Orientation Assessment
Blueprint v1.0.0 · 10 areas · 24-month validity
Provides evidence that a learner can recognise the core structures of regulated life sciences taught in the free Foundations series — why regulation exists, how a product moves from idea to patient, what GxP means, how regulated organisations are structured, and how records, deviations, data integrity, facilities, inspections and quality economics fit together.
Every area must be met on its own, and the overall score must reach 80%.
- The standard is non-compensatory: every domain must be satisfied independently, so a learner cannot pass by scoring well across nine modules while knowing nothing about, say, data integrity. In regulated work the domains are not interchangeable, and a compensatory standard would let the most consequential gap hide inside a good average.
- Each domain requires 2 of its 3 items. One item may be missed to absorb ambiguity in wording; two missed in a single domain is treated as not yet oriented in that domain rather than as bad luck.
- The 80% overall floor sits above the per-domain floor (which alone would allow 67%), so a learner who scrapes every domain still does not pass. The two rules together are what the standard is — neither is sufficient alone.
- This is an orientation standard, not a competence-to-practise standard. It was set to be defensible for what it claims, and the claim is deliberately small.
Up to 3 attempts in a rolling 12 months, with a 7-day wait between them.
- A cooling-off period exists because the item bank is fixed rather than sampled: without a wait, a retake would measure recall of the previous attempt rather than understanding of the material.
- The fixed bank is a known limitation of this pilot, stated rather than hidden. It is the reason attempts are capped and the reason the credential claims orientation and nothing more.
- A failed attempt is not recorded on the public verification page. Only an issued credential is public.
Lapses 24 months after issue.
The Foundations content is versioned and changes as regulation does. A credential asserting familiarity with a body of material cannot outlive the material by much, so it lapses at 24 months rather than standing indefinitely.
- The holder completed every module of the free SPEQ Foundations series.
- The holder met a published, non-compensatory passing standard on an assessment covering all ten modules.
- The assessment version and the date it was issued are recorded and publicly verifiable.
Which roles the competency map currently reaches
14 published competencies, mapped to 20 of the 48 roles the Navigator describes.
The other 28 roles are unmapped, which is not the same as scoring zero on them. No competency has been published against those roles yet, so the map makes no claim about them in either direction.
- Understands what it means to be personally named to an authority for a pharmacovigilance system — that the obligation does not distribute across a department, that a signal decision has to be reconstructable years later, and that acting internally while leaving the label unchanged is itself the finding. (leading)
- Recognises when a report becomes a reportable case, that the clock runs from the organisation’s first awareness by anyone, and that seriousness is a property of the event rather than of a causality view. (foundational)
- Understands what validating a computerised system establishes and what it does not — that effort is proportionate to risk, that a supplier can be leveraged but cannot validate your intended use, and that an audit trail exists so a record can be reconstructed rather than merely logged. (foundational)
- Can establish a root cause that survives challenge, distinguish correction from corrective action, and define an effectiveness criterion before the action closes — so that recurrence, not closure rate, is what the CAPA system is judged on. (working)
- Understands why device regulation centres on design controls and post-market surveillance rather than batch conformity — the product is used rather than consumed, and the user is part of the system. (foundational)
- Understands what validating a computerised system establishes and what it does not — that effort is proportionate to risk, that a supplier can be leveraged but cannot validate your intended use, and that an audit trail exists so a record can be reconstructed rather than merely logged. (foundational)
- Understands that a temperature excursion is a question answered from stability data rather than from the label, that stock is controlled before it is assessed, and that a repeating excursion on one lane is the finding rather than a series of events. (foundational)
- Recognises data-integrity expectations (ALCOA+) in everyday GxP records and knows when a record weakness must be escalated to Quality. (foundational)
- Understands the quality-system elements a QA function owns — deviations, change control, and independent release — and how they keep an organisation in a state of control. (foundational)
- Understands what validating a computerised system establishes and what it does not — that effort is proportionate to risk, that a supplier can be leveraged but cannot validate your intended use, and that an audit trail exists so a record can be reconstructed rather than merely logged. (foundational)
- Recognises data-integrity expectations (ALCOA+) in everyday GxP records and knows when a record weakness must be escalated to Quality. (foundational)
- Understands how a manufacturing operator keeps a process in its validated state of control and produces trustworthy contemporaneous records. (foundational)
- Understands how a QC laboratory generates trustworthy test data, handles out-of-specification results objectively, and protects the audit trail. (foundational)
- Understands how commissioning and qualification build and maintain the physical state of control, and how risk focuses verification effort. (foundational)
- Understands how clinical operations protects participant safety and data credibility under GCP, from the trial master file to database lock. (foundational)
- Understands how regulatory affairs manages the registered dossier and post-approval change so that what a company makes stays aligned with what regulators approved. (foundational)
- Understands that a temperature excursion is a question answered from stability data rather than from the label, that stock is controlled before it is assessed, and that a repeating excursion on one lane is the finding rather than a series of events. (foundational)
- Recognises when a report becomes a reportable case, that the clock runs from the organisation’s first awareness by anyone, and that seriousness is a property of the event rather than of a causality view. (foundational)
- Can establish a root cause that survives challenge, distinguish correction from corrective action, and define an effectiveness criterion before the action closes — so that recurrence, not closure rate, is what the CAPA system is judged on. (working)
- Understands why device regulation centres on design controls and post-market surveillance rather than batch conformity — the product is used rather than consumed, and the user is part of the system. (foundational)
- Understands why device regulation centres on design controls and post-market surveillance rather than batch conformity — the product is used rather than consumed, and the user is part of the system. (foundational)
- Understands why food safety is controlled at hazard points rather than by testing finished product — the volumes and timescales make sampling arithmetically incapable of finding what matters — and what a monitoring record is therefore evidence of. (foundational)
These roles have orientation content and a career pathway, but nothing in the competency registry maps to them. They are named here rather than omitted, because a coverage figure without its gaps is a claim about completeness that has not been earned.
How competence actually develops
Executes under supervision against a written method. Competence is demonstrated per task, and the honest measure is whether they know when to ask.
Performs the role unsupervised, recognises the abnormal, and can explain a record to someone who was not there.
Handles the cases the procedure does not cover, and can defend a decision made where the evidence was incomplete.
Decides what good looks like for others, and is answerable for the consequences of that definition.
What to learn, in what order
- FirstHow a regulated enterprise is actually structured
Without the structure, every specific obligation looks arbitrary.
Product 01 Enterprise Map, Product 02 Enterprise Explorer
- FirstWhere evidence lives and who owns each system
The most common practical question in the first year, and the easiest to answer badly.
Product 06 Systems and Data Fabric
- SecondHow a requirement becomes evidence
This is the reasoning the whole domain rests on.
Product 04 Requirement-to-Evidence Trace
- SecondWhat readiness means and how it is calculated
Teaches the difference between reported completion and verified readiness.
Product 03 Readiness Command Center
- ThirdWhat qualification proves and what it does not
The gap between these two is where most findings live.
Product 08 Commissioning and Qualification Planner
- ThirdHow your role sits among the others
Competence includes knowing whose question you are answering.
Product 11 Role and Competency Navigator, neighbourhood view
- FourthHow to answer questions about your own work
Retrieval under questioning is a distinct skill from doing the work.
Product 09 Inspection Readiness Simulator
- FourthHow to decide when the evidence is incomplete
The last thing learned and the hardest to teach.
The Decision Case Method
Who is in the room, stage by stage
The third column is the useful one. It says what follows from who is not there.
| Lifecycle stage | Who is present | What follows from who is not |
|---|---|---|
| Concept and intended use | Scientist, clinician, regulatory strategist | Nobody who will manufacture it is present, which is why transfer is hard later. |
| Design and development | Scientist, engineer, quality | Operator and maintainer perspective absent from decisions that determine their work. |
| Process transfer | Scientist, engineer, manufacturing, quality | Training is usually engaged too late to build curricula from the transfer package. |
| Qualification | Engineer, CQV professional, quality | Operations rarely owns the acceptance of the system it will run. |
| Routine manufacture | Operator, supervisor, engineer, quality | Adequately covered. This is the best-staffed stage in most organisations. |
| Testing and release | Analyst, quality, releasing person | Fine on paper; the releasing person is often the single point of failure. |
| Distribution | Supply chain, quality | Quality oversight of distribution conditions is thin almost everywhere. |
| Administration and use | Clinician, patient | No manufacturer role is present at all, by definition. |
| Surveillance and feedback | Quality, pharmacovigilance, regulatory | Design is absent from the stage whose whole purpose is to reach it. |