| Controlled documents and approvals | Documented by vendor | Manage document types, templates, version history, periodic review, group access, electronic approval roles and Microsoft Office editing. Validate the configured author/reviewer/approver/QA separation against internal procedures. Document controlPlans, product boundaries and commercial terms |
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| Training and retraining | Documented by vendor | Assign role-based or individual training plans, documents, tasks, links and assessments; track progress and trigger retraining when controlled documents change. Essential is the lowest named paid tier containing Training Management. Training managementPlans, product boundaries and commercial terms |
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| Training records for employees without accounts | Depends on scope | Supervisors can record completion and evidence for employees designated as offline users. Here 'offline user' means a person without platform login access; it is not evidence that the Scilife application works without network connectivity. Offline-user definitionTraining management |
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| Competence and CV management | Documented by vendor | Maintain competence categories and levels, employee CV data and supporting evidence, with manual updates or updates linked to completed training. Competences are listed in Essential; confirm governance of employee-entered records. Competency managementPlans, product boundaries and commercial terms |
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| Quality events and investigations | Documented by vendor | Configure deviations, nonconformities and complaints with custom fields, evidence, investigation, root-cause and impact assessment, responsible-party tags and QA sign-off. Closed events cannot be reopened; a new linked event is the documented path. Quality eventsPlans, product boundaries and commercial terms |
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| CAPA lifecycle and effectiveness checks | Documented by vendor | Define CAPA plans, approval signatures, implementation evidence, QA closure and optional effectiveness checks linked to events or change requests. The CAPA FAQ says plan and action fields are free text and individually assigned tasks need a linked Change Control request, while the page intro mentions assignable actions; confirm in a demo. CAPA managementPlans, product boundaries and commercial terms |
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| Change control | Documented by vendor | Document change rationale, risk and impact, cost and assigned tasks; route approval, implementation proof and QA closure; link CAPAs and document updates. Change requests cannot be reopened after closure, and task-level QA sign-off is configurable. Change controlPlans, product boundaries and commercial terms |
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| Audits, findings and supplier qualification | Depends on scope | Plan incoming, outgoing and internal audits, manage findings directly or through Events/CAPA, and run a supplier-qualification workflow that can trigger an audit. Audits and Supplier Management are listed in Core+, not Core or Essential. Audit and supplier qualification workflowsPlans, product boundaries and commercial terms |
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| Quality risk assessments | Depends on scope | Create risk assessments, use manual or question-based scoring, route mitigation/review/approval, schedule periodic reviews and link risks to events, CAPAs or audits. Risk Assessment is listed in Core+. Risk assessmentsPlans, product boundaries and commercial terms |
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| Equipment qualification, maintenance and calibration | Depends on scope | Register equipment by type and location, schedule recurring maintenance/calibration with owners and notifications, attach evidence and link equipment events. Equipment is listed in Core+; confirm whether qualification protocols and external calibration interfaces are included. Equipment managementPlans, product boundaries and commercial terms |
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| Permissions, signatures and auditability | Documented by vendor | Roles, groups and module permissions govern access; the pricing comparison lists MFA, IP controls, electronic signatures, audit trail and system log. Read-only users retain limited actions such as assigned training, so test least-privilege roles rather than relying on the label. User permissionsPlans, product boundaries and commercial terms |
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| API, SSO, provisioning and BI access | Depends on scope | Scilife describes a token-based REST API for selected records, Microsoft Entra ID SSO and SCIM provisioning, plus secure read-only database access for BI tools. Confirm plan entitlement, exact endpoints/entities, write restrictions, rate limits, support and database-access controls. Integrations, API, SSO and analytics access |
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