Our services for supplier qualification
Risk classification first
Before the questionnaire comes the question of what influence the supplier has on product quality, patient safety and data integrity. From that we derive the category and the assessment scope. This derivation is exactly where auditors probe, so we document it with a rationale rather than as a table value with no origin.
Documentation that holds
From SOPs and risk analyses to complete qualification documentation: we write and review the records on their substance, not only their format. We work inside your quality system, for example TrackWise or Veeva Vault Quality, and keep to your existing templates.
Supplier audits
Remote or on site, we assess suppliers against an assessment catalogue agreed in advance: quality management system, personnel qualification, software lifecycle, change and defect management, support and escalation. The output is an audit report with graded findings and deadlines, not a list of impressions.
Authority inspections and customer audits
We prepare teams step by step: records, roles, answers. One worked example is the supplier qualification case story. Follow-on services are equipment and facility qualification, Data Integrity and requirements engineering, because the URS supplies the assessment criteria.
Clarify scope?
Book an intro callLeistungs-Wegweiser
Welche Ausgangslage beschreibt Ihr Vorhaben?
Wählen Sie die Ausgangslage. Sie erhalten einen fokussierten Startpunkt mit Vertiefungen und Kontaktweg.
Vom Erstgespräch zum Plan
Wir klären Umfang, Rollen, Risiken und regulatorischen Rahmen und schlagen einen belastbaren Fahrplan vor.
Finding schließen
Root Cause, CAPA und Nachweise strukturiert aufbauen und QA-Abschluss vorbereiten.
Programm statt Einzelprojekt
PMO, Change Control und einheitliche Vorlagen über viele parallele Vorhaben hinweg.
In regulatory terms, accountability stays with the contract giver even when a service provider does the work. That applies equally to software vendors, instrument suppliers, calibration services and hosting providers: supplier evidence such as a factory OQ may only be used where its suitability has been assessed and documented.
Referenz: Case story: supplier qualification. Case Story lesen
What You Receive
Which deliverables do you need first?
Book an intro callRegulatory framework: EU GMP, ICH and FDA references
Assessment of suppliers and contractors is required explicitly, for materials as much as for IT services.
- EudraLex Volume 4, EU GMP Guide: Chapter 5 on supplier assessment and Chapter 7 on outsourced activities.
- EU GMP Annex 11, Computerised Systems: section 3.2 requires assessment of suppliers and development service providers.
- ISPE GAMP 5, 2nd Edition: supplier assessment and the conditions under which supplier evidence can be leveraged.
Our approach in GxP projects: from planning through release – each step delivers evidence you can present in QA review and audit. View GxP consulting in five steps
The supplier is part of your quality system
In regulatory terms, accountability stays with the contract giver even when a service provider does the work. That applies equally to software vendors, instrument suppliers, calibration services and hosting providers: supplier evidence such as a factory OQ may only be used where its suitability has been assessed and documented.
We work for purchasing, QA and system owners who need to approve a new vendor, reassess an existing supplier, or close a gap raised in an audit. Scope follows risk: a questionnaire where influence is low, an on-site audit where processes are critical.
Supplier Qualification Quick Check
Begin with our public Supplier Qualification Quick Check. Eight questions identify initial action areas covering risk classification, quality management, personnel, the software lifecycle and support.
Start the Quick CheckFAQ: Supplier qualification
Supplier qualification reference projects
FDA inspection, gap assessment, and ERP CSV in supplier programmes.
Supplier qualification
FDA-ready supplier qualification
Food manufacturer: gap analysis, supplier qualification, passed FDA inspection.
View case story
Supplier qualification
DI gap assessment
System landscape plus gap assessment on validated GxP software until findings are closed.
View case story
Supplier qualification
SYSPRO Annex 11
Canadian pharma manufacturer, new site in Germany: AI-assisted CSV with significantly reduced effort.
View case story