R-001-001 Control of documents

• Governed by GP-001 Control of documents
• Comes from template T-001-001 Control of documents

info

The Version column shows the short git commit hash of the last modification to each document. You can view the full history and changes using git log.

Quality management and others

Name	Code	Version
Quality Manual	QM	eb65a8ac33
Quality policy	Annex-001	dff05cc305
Process map	Annex-002	995b237087
Substitution table	Annex-004	4694e90189

General Procedures (GP)

Name	Code	Version
Control of documents	GP-001	b3de123798
Quality planning	GP-002	995b237087
Audits	GP-003	995b237087
Vigilance system	GP-004	995b237087
Human Resources and Training	GP-005	995b237087
Non-conformity, Corrective and Preventive actions	GP-006	995b237087
Post-market surveillance	GP-007	995b237087
Sales	GP-009	995b237087
Purchases and suppliers evaluation	GP-010	995b237087
Provision of service	GP-011	995b237087
Design, redesign and development	GP-012	995b237087
Risk management	GP-013	995b237087
Feedback and complaints	GP-014	995b237087
Clinical evaluation	GP-015	995b237087
Traceability and identification	GP-016	995b237087
Technical assistance service	GP-017	995b237087
Infrastructure and facilities	GP-018	995b237087
Non-product software validation	GP-019	4d39a1e09b
QMS Data analysis	GP-020	995b237087
Communications	GP-021	995b237087
Document translation	GP-022	995b237087
Change control management	GP-023	995b237087
Predetermined Change Control Plan	GP-024	995b237087
Usability and Human Factors Engineering	GP-025	995b237087
Corporate Governance	GP-027	995b237087
AI Development	GP-028	995b237087
Software Delivery and Commissioning	GP-029	995b237087
Cyber Security Management	GP-030	995b237087
Data Protection	GP-050	995b237087
Security violations	GP-051	995b237087
Data Privacy Impact Assessment (DPIA)	GP-052	995b237087
Business Continuity (BCP) and Disaster Recovery plans (DRP)	GP-100	995b237087
Information security	GP-101	995b237087
Esquema Nacional de Seguridad	GP-110	995b237087
Remote Data Acquisition in Clinical Investigations	GP-200	995b237087

Specific Procedures (SP)

Name	Code	Version
eIFU management	SP-001-001	995b237087
Process risk management	SP-002-001	995b237087
Product withdrawal	SP-004-001	995b237087
Anti-corruption and anti-bribery	SP-005-001	995b237087
Equipment Health Check	SP-005-002	995b237087
How to use the CRM	SP-009-001	995b237087
Contracts	SP-009-002	995b237087
How to share performance metrics	SP-009-003	995b237087
Implementation plan helpers	SP-009-004	995b237087
Implementation plan helpers for Clinical Trials	SP-009-005	995b237087
Integration workflow helpers	SP-009-006	995b237087
Scoring Systems Catalog	SP-009-007	995b237087
Conditions List & Visual Assets	SP-009-008	995b237087
Integration per client	SP-011-001	995b237087
Remote infrastructure control access policy	SP-018-001	995b237087
Data protection officer manual	SP-050-001	995b237087
Manual of functions and obligations of the staff	SP-050-002	995b237087
Data sharing	SP-050-003	995b237087

Country-Specific Procedures

Name	Code	Version
Brazil	SP-026-BR	995b237087
United Kingdom	SP-026-UK	995b237087
United States of America	SP-026-US	995b237087

GP-110 Sub-procedures (Esquema Nacional de Seguridad)

Name	Code	Version
Política de Seguridad	ORG.1	995b237087
Protección de los equipos	MP.EQ	995b237087
Protección de los servicios	MP.S	995b237087
Protección de la información	MP.INFO	995b237087
Gestión del personal	MP.PER	995b237087
Protección de los soportes de información	MP.SI	995b237087
Protección de las aplicaciones informáticas	MP.SW	995b237087
Protección de las comunicaciones	MP.COM	995b237087
Protección de Medios Auxiliares	MP.AUX	995b237087
Servicios en la nube	OP.NUB.1	995b237087
Continuidad del servicio	OP.CONT	995b237087

Templates

Name	Code	Version
Control of documents	T-001-001	995b237087
Manufacturer declaration of conformity_MDD	T-001-002	995b237087
List of external documents	T-001-005	995b237087
IFU and label validation	T-001-006	995b237087
Manufacturer declaration of conformity_MDR	T-001-007	995b237087
Device name labeling	T-001-008	995b237087
Quality objectives list	T-002-001	995b237087
Quality objectives	T-002-002	995b237087
Quality indicators	T-002-003	995b237087
Annual management review report	T-002-004	995b237087
Quality calendar	T-002-005	995b237087
Process validation card	T-002-007	995b237087
Audits program	T-003-001	995b237087
Internal auditor qualification	T-003-002	995b237087
Internal audit plan	T-003-003	995b237087
Internal audit checklist	T-003-004	995b237087
Internal audit report	T-003-005	995b237087
Withdrawal record	T-004-001	995b237087
Job description	T-005-001	995b237087
Training plan	T-005-003	995b237087
Training evaluation and record	T-005-004	995b237087
GDPR training	T-005-006	995b237087
Technical Responsible designation	T-005-007	995b237087
PRRC designation	T-005-008	995b237087
QMS procedures training	T-005-009	995b237087
Email footer generator	T-005-010	995b237087
Non-conformity and CAPA	T-006-001	995b237087
PMS plan	T-007-001	995b237087
PMCF plan	T-007-002	995b237087
PSUR	T-007-003	995b237087
PMS evaluation report	T-007-004	995b237087
PMCF evaluation report	T-007-005	995b237087
Sanitary alerts databases	T-007-006	995b237087
Implementation plan	T-009-001	995b237087
Quotation for API	T-009-002	995b237087
Terms of service and licensing agreement	T-009-003	995b237087
Quotation for Clinical Trials	T-009-004	995b237087
Suppliers evaluation	T-010-001	995b237087
API key order	T-011-001	995b237087
API key delivery	T-011-002	995b237087
DeepLink and App keys order	T-011-003	995b237087
DeepLink and App keys delivery	T-011-004	995b237087
Requirements	T-012-001	995b237087
Test run	T-012-003	995b237087
Software version release	T-012-004	995b237087
Design change control	T-012-005	995b237087
Life cycle plan and report	T-012-006	995b237087
Formative evaluation plan	T-012-007	995b237087
Formative evaluation report	T-012-008	995b237087
Validation and testing of machine learning models	T-012-009	995b237087
Device back up verification	T-012-010	995b237087
Customer product version control	T-012-011	995b237087
Summative evaluation plan	T-012-014	995b237087
Summative evaluation report	T-012-015	995b237087
Software usability test guide	T-012-016	995b237087
Integration test review	T-012-017	995b237087
Test plan	T-012-018	995b237087
SOUP	T-012-019	995b237087
Predetermined Change Control Plan	T-012-020	995b237087
Risk Management Plan	T-013-001	995b237087
Risk Management Record	T-013-002	995b237087
Risk Management Report	T-013-003	995b237087
Customer Satisfaction Survey	T-014-001	995b237087
Clinical Evaluation Plan	T-015-001	995b237087
State of the Art	T-015-011	995b237087
Clinical Evaluation Report CER	T-015-003	995b237087
Clinical investigation plan	T-015-004	995b237087
Investigator's brochure	T-015-005	995b237087
Clinical investigation report (EN)	T-015-006_EN	995b237087
Clinical investigation report (ES)	T-015-006_ES	995b237087
Declaration of interest Clinical evaluation team	T-015-007	995b237087
Clinical development plan	T-015-008	995b237087
Clinical Investigation Plan_Study code_en	T-015-009	995b237087
Infrastructure list and control plan	T-018-001	995b237087
Infrastructure and facilities incidents log	T-018-002	995b237087
Software validation report	T-019-001	995b237087
External software list	T-019-002	995b237087
Trend report	T-020-001	995b237087
Change control	T-023-001	995b237087
Pre-submission meeting request	T-026-001	995b237087
Processing activities (ROPA)	T-050-001	995b237087
Data access key	T-050-003	995b237087
API event logs	T-051-001	995b237087
Security groups	T-051-002	995b237087
EC2 instances	T-051-003	995b237087
DPIA	T-052-001	995b237087
Summary of Clinical Validation of Data Acquisition Digital Health Technology	T-200-001	995b237087

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

• Author: Team members involved
• Reviewer: JD-003 Design & Development Manager, JD-004 Quality Manager & PRRC
• Approver: JD-001 General Manager