Requirements & intended use
Define business process, regulated use, roles, interfaces, records and acceptance criteria before configuration.
Compliance · validation · data integrity
Laboratory informatics designed for evidence, control and defensible processes.
Zylon provides configurable controls that can support regulated and accredited laboratory operating models. The platform is designed to help laboratories establish controlled electronic workflows, attributable records, review evidence and validation documentation around their intended use.
Regulatory & quality context
Controls that can support major laboratory and electronic-record expectations.
Zylon should be assessed and validated against each customer's actual intended use, applicable regulations, accreditation scope, procedures and risk profile. Software capability alone does not confer regulatory compliance or laboratory accreditation.
ISO/IEC 17025Testing & calibration laboratoriesSupport controlled sample identification, technical records, methods, equipment context, review, reporting, competence evidence and traceable quality workflows.
21 CFR Part 11Electronic records & signaturesSupport controlled electronic records, identity-aware approvals, attributable activity history and electronic-signature workflows where configured and validated for the intended use.
EU GMP Annex 11Computerised systemsSupport risk-based validation, identity and access management, audit trails, electronic approvals, security, backup, archiving and periodic review expectations within a customer-controlled quality system.
ALCOA+Data integrity principlesDesign records and workflows so data can remain attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring and available.
Validation lifecycle
Validation is treated as a lifecycle—not a final checkbox.
A structured implementation creates a clearer chain from intended use and configured controls to test evidence, training, production release and controlled change.
Risk & control mapping
Identify critical data, approvals, segregation requirements, integrations and controls that require objective evidence.
Configuration & master data
Build controlled workflows, forms, methods, specifications, roles and master records using approved configuration inputs.
Verification & validation
Execute customer-defined testing and evidence activities for configured workflows, permissions, reports and integrations.
Training & controlled go-live
Prepare users, approve production readiness and introduce the system through authorised operational procedures.
Change & periodic review
Assess significant changes, maintain evidence and periodically review continued fitness for intended use.
Data integrity
Make laboratory records trustworthy by design.
The system architecture and configured workflows are intended to support reliable evidence of who did what, when, under which process and with which review or approval responsibility.
Attributable
Identify the user and responsibility associated with critical actions, entries, reviews and approvals.
Contemporaneous
Capture workflow events and decisions in operational context instead of reconstructing them later from disconnected records.
Complete & consistent
Keep sample, test, result, quality and approval context linked through a controlled lifecycle.
Reviewable evidence
Provide traceable records and activity history that authorised reviewers can evaluate during investigations, audits and periodic reviews.
Controlled access
Restrict creation, modification, review and approval according to role, site, laboratory and assigned responsibility.
Change governance
Support configuration control and validation evidence so significant changes can be assessed before regulated use.
Customer responsibility
Compliance is shared between software controls and operating discipline.
Zylon can provide configurable technical controls and implementation evidence. Each laboratory remains responsible for its procedures, risk assessment, validation scope, user administration, training, data governance, accreditation and regulatory obligations.
Zylon platformConfigurable workflows, permissions, auditability, electronic approvals, controlled records, integrations and reporting capability.
Zylon implementationRequirements mapping, configuration support, test evidence, change documentation and deployment guidance as agreed for the engagement.
Customer quality systemIntended use, SOPs, risk decisions, validation acceptance, user governance, training, periodic review and regulated operating procedures.
Accreditation / regulatorIndependent assessment of the laboratory or regulated operation against the applicable standard, regulation and approved scope.