IAAPP
Cloud platform for healthcare quality systems

The intelligent quality system for healthcare

IAAPP is the platform developed by ICMED for quality system management in healthcare facilities: a single cloud service for documents, audits, non-conformities and CAPA, clinical pathways, validations, competencies and indicators.

IAAPP can be adopted as a stand-alone solution, with no ICMED consulting or training required.

SaaS Cloud service, browser access
IT · EN Interface in Italian and English
Level 1 Cloud service ACN-qualified at level 1
MFA Multi-factor authentication users can enable
ICMED S.r.l.: ISO/IEC 27001 (CSQA)

ICMED S.r.l.'s IAAPP cloud service is ACN-qualified at level 1, published classification Public Cloud — catalogue entry SA-8234 — Verify in the catalogue
The qualification covers the IAAPP cloud service only: it does not extend to all the software's functions, to other products or to the company as a whole. IAAPP is SaaS software for quality management.

Born in the most regulated fields, suited to every healthcare facility

IAAPP was born alongside those who work with the strictest requirements. That is why it can now run the quality system of any healthcare facility: documents, audits, competencies, equipment, non-conformities, corrective actions and risk management in a single environment.

Haematopoietic stem cell transplant programmes (HPC)

Documents, audits, indicators and corrective actions of the programme in a single environment.

CAR-T, IEC and cell and gene therapy centres

Procedures, audits, validations and action tracking for centres handling several standards.

ART / IVF centres

Documents, staff training and competencies, equipment maintenance, non-conformities.

Transfusion services

Validations, change control, equipment and non-conformities.

Laboratories, including ISO 15189

Document control, competencies, equipment and internal audits.

Other healthcare facilities

Hospitals and outpatient facilities: if you have a quality system to manage, IAAPP is tailored to your procedures, your documents and the standards you apply.

Let's talk

Problems IAAPP helps to manage

  • Documents and procedures scattered across folders and files, with revisions that are hard to control
  • Deadlines for documents, equipment, validations and training followed by hand
  • Non-conformities, corrective actions and audits recorded in separate tools
  • Staff competencies and training that are hard to demonstrate
  • Several standards and regulations to manage together without duplicating evidence
  • Risk management: risks to identify, assess and treat in a documented way, with a risk matrix linked to audits, non-conformities and corrective actions

Main functions

Documents

Folders, versions, approval and periodic renewal of expiring documents.

Training

Training plan, events and records; training plan report in Italian or English.

Competencies

Competency profiles and staff assessments, with a radar chart of the results.

Indicators and KPIs

Indicators with target and result, linked to regulations and corrective actions.

Non-conformities and CAPA

Recording, root cause analysis with selectable methods (including 5 Whys, Ishikawa and FMEA), corrective and preventive actions.

Audits

Planning, execution and findings, linked to non-conformities and CAPA.

Equipment and maintenance

Register, maintenance log, qualification dates and traffic-light status.

Validation

IQ/OQ/PQ phases, tests, scheduled revalidation and link to CAPA.

Change control

Change register with approval; one is also created by the automatic renewal of documents.

Compliance check

Regulatory checklists with reports and a radar chart by category.

The platform

The platform

IAAPP for your sector

IAAPP is the quality management platform: each version names the sector it is aimed at and the functions most useful in that context. The functions described are those available in the platform.

IAAPP

IAAPP — Quality management for healthcare organisations

IAAPP is a platform for managing the quality system of healthcare organisations and facilities, including specialist ones. Documents, audits, competencies, equipment, non-conformities, corrective actions and risk management in a single environment, configurable to the processes and standards that apply to the organisation.

Configuring IAAPP is an ICMED service to be agreed with the organisation; it does not mean automatic compliance with any standard or regulatory requirement.

Let's talk about your organisation
IAAPP Fert

ART / IVF centres

Documents, staff training and competencies, equipment maintenance, non-conformities.

Request an IAAPP Fert demo
IAAPP Gene

CAR-T, IEC and cell and gene therapy centres

Procedures, audits, validations and action tracking for centres handling several standards.

Request an IAAPP Gene demo
IAAPP Hla

Immunogenetics (HLA laboratories)

Document control, competencies, equipment and internal audits.

Request an IAAPP Hla demo
IAAPP Lab

Laboratories, including ISO 15189

Document control, competencies, equipment and internal audits.

Request an IAAPP Lab demo

A demo request does not activate accounts, access or trial environments: it tells us which sector you are interested in.

01

Document Management

Complete document management system with folder structure, version control, approval workflows and read tracking.
Document upload with chunk support for large filesGranular permissions by role and folder (upload, edit, delete)Document approval with automatic PDF stampingMandatory read tracking for staffFull-text search and advanced filters
02

Audits and Inspections

Planning, execution and reporting of internal and external audits with comprehensive findings management.
Annual audit plan with inspector assignmentCustomisable checklists for standards (JACIE, EFI, GMP, ISO)Findings recording with severity classificationDirect linking to non-conformities and corrective actionsAutomatically generated audit reports
03

Non-Conformities and CAPA

Integrated non-conformity management with polymorphic CAPA (Corrective and Preventive Actions) workflow.
NC recording with classification, root cause and impactCAPA linkable to NCs, risk assessments, change controls, validationsWorkflow with statuses, deadlines and automatic notificationsStatistical dashboards with AI analysis (trends, recurrences, effectiveness)Integration with Management Review
04

Clinical Pathways (PDTA)

Dedicated module for designing, implementing and monitoring Clinical Pathways in a digital and integrated way.
Pathway definition with quality indicators and measurementsAutomatic conformity calculation for each indicatorInteractive dashboards with trends over timeReports for management and regulatory bodiesAI-assisted document import
05

Validation and Change Control

Validation lifecycle designed around the applicable requirements, with integrated change control management.
Validation with IQ/OQ/PQ phases, tests and acceptance criteriaTypes: process, equipment, analytical method, information systemAutomatic revalidation schedulingChange control with approval workflow and impact analysisAttachments and documentation at every level
06

Human Resources, Competencies and Training

Complete management of staff, competencies and continuing education.
Organisational chart with operating units, sections and positionsCompetency profiles with activities and categoriesTraining event recording with automatic PDF certificate generationAnnual training plan with bilingual report (ITA/ENG)Hours and activity tracking for each operator
07

Indicators, Risk Assessment and Compliance

KPI monitoring, risk assessment and regulatory compliance verification with artificial intelligence support.
KPIs with regulation association and CAPA integrationRisk matrix with assessment and treatmentAI Compliance Checker: automatic regulatory checklist verification with non-conformity report and radar chartCompliance reports per regulation (documents, audits, NCs, KPIs, training)Dynamic ISMS reports for ISO 27001: document index, risk register, SoA, audit plan, asset inventory
08

Equipment and Inventory

Equipment tracking, maintenance, qualification and operational status with traffic-light system.
Equipment registry with technical data and locationPlanned and unplanned maintenance schedulingMaintenance logs with attachmentsQualification status (green/yellow/red) with expiry dates
09

Multi-organisation and Security

Multi-tenant architecture with data isolation per organisation, multi-factor authentication and role-based access control.
Each organisation operates in an isolated environmentRBAC with granular permissionsOptional MFA/TOTP authenticationSocial login (Google, Microsoft) with CSRF validationREST API protected via OAuthHospital departmental structure (DAI → UOC) with ward-based visibility
10

Artificial Intelligence

IAAPP includes artificial intelligence functions that support analysis and decision-making.
Statistical analysis of non-conformities and trendsSupport for indicator and audit analysisAutomatic Management Review generationCompliance Checker with auto-audit and reportingDocument import and analysis for clinical pathways
11

Data Sovereignty & Security

The IAAPP cloud service runs on Aruba Cloud (VPS) infrastructure with a data centre in Italy (Arezzo), as stated in entry SA-8234 of the ACN catalogue. The processing of personal data on behalf of customers is governed by a data processing agreement under Article 28 GDPR, available on request.

Security features:
- Cloud service ACN-qualified at level 1 (entry SA-8234); data hosted in Italy
- ICMED S.r.l.: ISO/IEC 27001 certification (CSQA), with controls supplemented by the ISO/IEC 27017 (cloud) and 27018 (personal data in the cloud) guidelines
- Multi-factor authentication that users can enable (app or e-mail code)
- Backup, business continuity and encryption: measures described in the reference documentation, available on request
- RBAC with granular permissions by role and department

The IAAPP organisation

IAAPP is a software product of ICMED S.r.l. with a dedicated organisation: commercial development and coordination, product management, demos and product support.

Elisa Iaconianni

Elisa Iaconianni

IAAPP commercial development and coordination

IAAPP Business Unit.

Marco Mazzanti

Marco Mazzanti

IAAPP Product Manager

IAAPP Business Unit: requirements, functional evolution, demos and support.

Team and organizational chart →

How it is adopted

Stand-alone SaaS

IAAPP is adopted on its own, as a cloud service: it does not require ICMED consulting or training.

Demo and scope

In a demo we agree the modules, users and languages useful to your organisation.

Complementary consulting

If you need it, ICMED can support the set-up of the quality system and documents.

Complementary training

ECM courses for staff are chosen separately.

Security and certifications: what each one refers to

  • IAAPP Quality Management System: SaaS software for quality management; the cloud service is ACN-qualified at level 1, published classification Public Cloud — catalogue entry SA-8234 of the ACN catalogue. The qualification covers the IAAPP cloud service only, not all the software's functions or ICMED S.r.l.
  • ISO/IEC 27001 (UNI CEI EN ISO/IEC 27001:2024): certification of ICMED S.r.l. as an organisation, issued by CSQA, with a statement of applicability supplemented by the controls of the ISO/IEC 27017 and 27018 guidelines for cloud services. The certified activities include the delivery of the IAAPP platform in SaaS mode (Certifications page).
  • Infrastructure providers hold their own qualifications and certifications: they are not ICMED certifications.

Reference documentation (certificates, data processing agreement) is available on request.

Official catalogue entry SA-8234

All ICMED certifications and qualifications

IAAPP is a tool that supports the quality system: compliance, accreditations and inspection outcomes depend on how the organisation adopts it and on the decisions of the competent bodies, and cannot be promised by ICMED. No savings or economic returns are promised.

Want to see IAAPP on your organisation?

Request a demo: we show you the functions useful to your case. Consulting and training are complementary, independent services.

Already a customer? Access your instance

Frequently Asked Questions

What is IAAPP?

IAAPP (Integrated Audit & Accreditation Platform) is the platform developed by ICMED S.r.l. for managing the quality system in healthcare facilities: documents, audits and checklists, non-conformities and corrective actions, validations, competencies and indicators.

Can IAAPP be used for JACIE inspections?

IAAPP is designed to support the preparation and management of programmes accredited to FACT-JACIE standards: audits with customisable checklists, findings linked to non-conformities and CAPA, documents and reports. The outcome of an inspection depends on the organisation and the inspecting body, not on the tool.

Can I adopt IAAPP without ICMED consulting?

Yes. IAAPP is a stand-alone SaaS service: ICMED consulting and training are complementary, independent services and can be chosen separately.

Who is IAAPP for?

Healthcare organisations that want to manage their quality system in a structured way: transplant programmes, CAR-T and IEC centres, ART centres, transfusion services and laboratories.

Does IAAPP ensure compliance or accreditation?

No. It is a support tool: compliance, accreditations and inspection outcomes depend on how the organisation adopts it and on the decisions of the competent bodies.

What does the qualification of the IAAPP cloud service mean?

IAAPP Quality Management System is SaaS software for quality management; its cloud service is ACN-qualified at level 1, published classification Public Cloud (catalogue entry SA-8234 of the ACN catalogue). The qualification covers the IAAPP cloud service only, not all the software's functions, other products or the company as a whole.

Does the ISO/IEC 27001 certification refer to the product or to the company?

It is the certification of ICMED S.r.l. as an organisation, issued by CSQA (UNI CEI EN ISO/IEC 27001:2024). The certified activities include the delivery of the IAAPP platform in SaaS mode, and the statement of applicability is supplemented by the controls of the ISO/IEC 27017 and 27018 guidelines for cloud services. IAAPP itself is not an "ISO-certified product" and the certification should not be confused with the qualification of the cloud service.

How do I request a demo?

Use the «Request a demo» button: the contact form reaches ICMED with the IAAPP request type. In the demo we agree the modules and scope useful to your organisation.

Scientific Insights & Magazine

ICMED Magazine (ISSN 3103-1943) — the scientific journal dedicated to quality and innovation in healthcare

Scientific journal with ISSN 3103-1943 and a DOI for each article. From the Magazine to training: turning an issue into an online (FAD) course is a project under definition and no course based on the Magazine is available today. To apply the topics in your facility: consulting, with IAAPP as a complementary digital service.