For Quality Managers
A real validation pack, not a wave of the hand.
Supplier documentation for laboratories operating under, or pursuing, ISO 15189 / UKAS accreditation. Request access below; we'll review and email the PDFs within one working day.
What's in the pack
Ten documents, ~30 pages, written for your QM.
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1
System overviewArchitecture, hosting region (UK), suppliers, security controls. Attach to your supplier file.
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2
Data integrity (ALCOA+) statementPoint-by-point: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available. Plus the lab-specific extensions — result traceability chain, QC evaluation transparency, email trail.
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3
System validation summaryGAMP 5 Category 4 declaration. Explicit on what we (the supplier) validate vs what your laboratory must validate during its PQ.
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4
Audit trail review procedureWeekly / monthly / quarterly cadences, red flags, investigation playbook. Adopt as-is or adapt.
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5
Known gaps and roadmapThe honest list. No MFA on password logins yet, no third-party pen test in the last 12 months, no published uptime SLA — with customer compensating measures for each. The most important document in the pack.
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6–9
Four SOP templatesUser account management · Access control review · Backup verification · Change management. Bracketed placeholders for your QM to adapt and adopt.
What the pack is not.
Turnkey accreditation. Your laboratory remains responsible for its own ISO 15189 compliance — including Performance Qualification of FreshLIMS in your environment, and the operational SOPs that govern its use. We provide the supplier documentation you attach to your quality system; you do the rest.
Request the pack
Reviewed by a human. Reply within one working day.