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Orientation in eight questions

Supplier Qualification Quick Check for GxP Suppliers

In a few minutes, assess whether the selection, quality management, personnel, software lifecycle and support of a critical supplier have been evaluated robustly. The result identifies initial prioritised action areas.

A structured quick check, not a supplier audit

The questions condense the core topics in the underlying supplier questionnaire. Scoring is explicit: Yes or, for conditional chapters, Not applicable = 3, Partly = 2, Unknown = 1, No = 0. The result provides orientation and replaces neither a risk-based supplier assessment nor an audit.

Supplier Review · 8 questions
Step 1 of 2
Step 1: selection and organisation
01 · Risk classificationAre the service scope, GxP relevance, affected systems or processes and supplier criticality documented and assessed?

Derived from chapters 1.1 and 1.2 of the supplier questionnaire covering the assignment, company information and applicable qualification elements.

02 · Quality managementDoes the supplier demonstrate a formal quality management system with clear quality assurance responsibility, current certificates or independent audits?

Derived from chapter 1.3 of the supplier questionnaire covering quality management, certification and internal audits.

03 · Service deliveryAre project management, project controls, traceable documentation, change control and archiving regulated for the contracted service?

Derived from chapter 1.4 of the supplier questionnaire covering services, consulting and project controls.

04 · Personnel qualificationIs role-based qualification evidence available for assigned internal and external personnel, together with documented ongoing training?

Derived from chapters 1.2 and 1.5 of the supplier questionnaire covering external personnel, experience and ongoing qualification.

Step 2: software lifecycle and service continuity
05 · Software developmentIf software is developed, are the SDLC, development records, code reviews, independent tests, versioning and defect handling governed by mandatory procedures?

Derived from chapter 1.6 of the supplier questionnaire covering the System Development Life Cycle.

06 · Implementation and validationIf software is implemented, are requirements, specifications, installation, tests, acceptance, change control and validation support documented?

Derived from chapter 1.7 of the supplier questionnaire covering software implementation. For electronic records, the questionnaire also names FDA 21 CFR Part 11.

07 · Support and maintenanceAre support channels, availability, maintenance scope, service levels, escalation routes and the committed support duration clearly agreed?

Derived from chapter 1.8 of the supplier questionnaire covering customer service, support and maintenance.

08 · Lifecycle and evidenceAre data migration during upgrades, long-term readability after retirement, necessary source code availability and complete attachments secured?

Derived from chapter 1.9 and chapters 2 and 3 of the supplier questionnaire covering project-specific questions, confirmation and attachments.

Context and target groups

Document basis

The questions follow the chapters of the supplied supplier questionnaire, from company information through the attachment register. They deliberately reduce its scope to an initial orientation.

For contracting organisations

Quality assurance, purchasing and subject matter teams gain an initial view of evidence gaps and critical contractual or audit points.

For suppliers

Software providers and service suppliers see which QMS, personnel, SDLC, implementation and support evidence is typically expected.

Prepare supplier qualification with robust evidence

Discuss risk classification, the questionnaire, audit scope and the qualification decision with our advisory team.

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