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	5e7be683c
Quality policy	Annex-001	d81e1f1f27
Process map	Annex-002	d81e1f1f27
Substitution table	Annex-004	d81e1f1f27

General Procedures (GP)

Name	Code	Version
Control of documents	GP-001	d81e1f1f27
Quality planning	GP-002	18e1786912
Audits	GP-003	d81e1f1f27
Vigilance system	GP-004	d81e1f1f27
Human Resources and Training	GP-005	18e1786912
Non-conformity, Corrective and Preventive actions	GP-006	d81e1f1f27
Post-market surveillance	GP-007	d81e1f1f27
Sales	GP-009	d81e1f1f27
Purchases and suppliers evaluation	GP-010	5a215c6a5e
Provision of service	GP-011	5a215c6a5e
Design, redesign and development	GP-012	d7fa95e962
Risk management	GP-013	d7fa95e962
Feedback and complaints	GP-014	5a215c6a5e
Clinical evaluation	GP-015	5a215c6a5e
Traceability and identification	GP-016	d81e1f1f27
Technical assistance service	GP-017	5a215c6a5e
Infrastructure and facilities	GP-018	5a215c6a5e
Non-product software validation	GP-019	5a215c6a5e
QMS Data analysis	GP-020	d81e1f1f27
Communications	GP-021	5a215c6a5e
Document translation	GP-022	d81e1f1f27
Change control management	GP-023	d7fa95e962
Predetermined Change Control Plan	GP-024	5a215c6a5e
Usability and Human Factors Engineering	GP-025	d7fa95e962
Corporate Governance	GP-027	5a215c6a5e
AI Development	GP-028	9398f92d35
Software Delivery and Commissioning	GP-029	d7fa95e962
Cyber Security Management	GP-030	d7fa95e962
Data Protection	GP-050	5a215c6a5e
Security violations	GP-051	5a215c6a5e
Data Privacy Impact Assessment (DPIA)	GP-052	5a215c6a5e
Business Continuity (BCP) and Disaster Recovery plans (DRP)	GP-100	5a215c6a5e
Information security	GP-101	5a215c6a5e
Esquema Nacional de Seguridad	GP-110	5a215c6a5e
Remote Data Acquisition in Clinical Investigations	GP-200	5a215c6a5e

Specific Procedures (SP)

Name	Code	Version
eIFU management	SP-001-001	d81e1f1f27
Process risk management	SP-002-001	6a2694bb49
Product withdrawal	SP-004-001	d81e1f1f27
Anti-corruption and anti-bribery	SP-005-001	d81e1f1f27
Equipment Health Check	SP-005-002	d81e1f1f27
How to use the CRM	SP-009-001	d81e1f1f27
Contracts	SP-009-002	d81e1f1f27
How to share performance metrics	SP-009-003	d81e1f1f27
Implementation plan helpers	SP-009-004	d81e1f1f27
Implementation plan helpers for Clinical Trials	SP-009-005	d81e1f1f27
Integration workflow helpers	SP-009-006	d81e1f1f27
Scoring Systems Catalog	SP-009-007	d81e1f1f27
Conditions List & Visual Assets	SP-009-008	d81e1f1f27
Integration per client	SP-011-001	5a215c6a5e
Remote infrastructure control access policy	SP-018-001	5a215c6a5e
Data protection officer manual	SP-050-001	5a215c6a5e
Manual of functions and obligations of the staff	SP-050-002	5a215c6a5e
Data sharing	SP-050-003	5a215c6a5e

Country-Specific Procedures

Name	Code	Version
Brazil	SP-026-BR	4111236ff3
United Kingdom	SP-026-UK	4111236ff3
United States of America	SP-026-US	e8eebdc64f

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

Name	Code	Version
Política de Seguridad	ORG.1	5a215c6a5e
Protección de los equipos	MP.EQ	5a215c6a5e
Protección de los servicios	MP.S	5a215c6a5e
Protección de la información	MP.INFO	5a215c6a5e
Gestión del personal	MP.PER	5a215c6a5e
Protección de los soportes de información	MP.SI	5a215c6a5e
Protección de las aplicaciones informáticas	MP.SW	5a215c6a5e
Protección de las comunicaciones	MP.COM	5a215c6a5e
Protección de Medios Auxiliares	MP.AUX	5a215c6a5e
Servicios en la nube	OP.NUB.1	5a215c6a5e
Continuidad del servicio	OP.CONT	5a215c6a5e

Templates

Name	Code	Version
Control of documents	T-001-001	d81e1f1f27
Manufacturer declaration of conformity_MDD	T-001-002	d81e1f1f27
List of external documents	T-001-005	d81e1f1f27
IFU and label validation	T-001-006	d81e1f1f27
Manufacturer declaration of conformity_MDR	T-001-007	d81e1f1f27
Device name labeling	T-001-008	d81e1f1f27
Quality objectives list	T-002-001	d81e1f1f27
Quality objectives	T-002-002	d81e1f1f27
Quality indicators	T-002-003	d81e1f1f27
Annual management review report	T-002-004	d81e1f1f27
Quality calendar	T-002-005	d81e1f1f27
Process validation card	T-002-007	d81e1f1f27
Audits program	T-003-001	d81e1f1f27
Internal auditor qualification	T-003-002	d81e1f1f27
Internal audit plan	T-003-003	d81e1f1f27
Internal audit checklist	T-003-004	d81e1f1f27
Internal audit report	T-003-005	d81e1f1f27
Withdrawal record	T-004-001	d81e1f1f27
Job description	T-005-001	6963af53e3
Training plan	T-005-003	d81e1f1f27
Training evaluation and record	T-005-004	d81e1f1f27
GDPR training	T-005-006	d81e1f1f27
Technical Responsible designation	T-005-007	d81e1f1f27
PRRC designation	T-005-008	d81e1f1f27
QMS procedures training	T-005-009	d81e1f1f27
Email footer generator	T-005-010	d81e1f1f27
Non-conformity and CAPA	T-006-001	d81e1f1f27
PMS plan	T-007-001	d81e1f1f27
PMCF plan	T-007-002	d81e1f1f27
PSUR	T-007-003	d81e1f1f27
PMS evaluation report	T-007-004	d81e1f1f27
PMCF evaluation report	T-007-005	d81e1f1f27
Sanitary alerts databases	T-007-006	d81e1f1f27
Implementation plan	T-009-001	d81e1f1f27
Quotation for API	T-009-002	d81e1f1f27
Terms of service and licensing agreement	T-009-003	d81e1f1f27
Quotation for Clinical Trials	T-009-004	d81e1f1f27
Suppliers evaluation	T-010-001	5a215c6a5e
API key order	T-011-001	5a215c6a5e
API key delivery	T-011-002	5a215c6a5e
DeepLink and App keys order	T-011-003	5a215c6a5e
DeepLink and App keys delivery	T-011-004	fad9db146b
Requirements	T-012-001	5a215c6a5e
Test run	T-012-003	5a215c6a5e
Software version release	T-012-004	5a215c6a5e
Design change control	T-012-005	5a215c6a5e
Life cycle plan and report	T-012-006	5a215c6a5e
Formative evaluation plan	T-012-007	5a215c6a5e
Formative evaluation report	T-012-008	5a215c6a5e
Validation and testing of machine learning models	T-012-009	5a215c6a5e
Device back up verification	T-012-010	5a215c6a5e
Customer product version control	T-012-011	5a215c6a5e
Summative evaluation plan	T-012-014	5a215c6a5e
Summative evaluation report	T-012-015	5a215c6a5e
Software usability test guide	T-012-016	5a215c6a5e
Integration test review	T-012-017	5a215c6a5e
Test plan	T-012-018	5a215c6a5e
SOUP	T-012-019	5a215c6a5e
Predetermined Change Control Plan	T-012-020	5a215c6a5e
Risk Management Plan	T-013-001	5a215c6a5e
Risk Management Record	T-013-002	5a215c6a5e
Risk Management Report	T-013-003	5a215c6a5e
Customer Satisfaction Survey	T-014-001	5a215c6a5e
Clinical Evaluation Plan	T-015-001	5a215c6a5e
State of the Art	T-015-011	5a215c6a5e
Clinical Evaluation Report CER	T-015-003	5a215c6a5e
Clinical investigation plan	T-015-004	5a215c6a5e
Investigator's brochure	T-015-005	5a215c6a5e
Clinical investigation report (EN)	T-015-006_EN	5a215c6a5e
Clinical investigation report (ES)	T-015-006_ES	5a215c6a5e
Declaration of interest Clinical evaluation team	T-015-007	5a215c6a5e
Clinical development plan	T-015-008	5a215c6a5e
Clinical Investigation Plan_Study code_en	T-015-009	5a215c6a5e
Infrastructure list and control plan	T-018-001	5a215c6a5e
Infrastructure and facilities incidents log	T-018-002	5a215c6a5e
Software validation report	T-019-001	5a215c6a5e
External software list	T-019-002	5a215c6a5e
Trend report	T-020-001	d81e1f1f27
Change control	T-023-001	5a215c6a5e
Pre-submission meeting request	T-026-001	4111236ff3
Processing activities (ROPA)	T-050-001	5a215c6a5e
Data access key	T-050-003	5a215c6a5e
API event logs	T-051-001	5a215c6a5e
Security groups	T-051-002	5a215c6a5e
EC2 instances	T-051-003	5a215c6a5e
DPIA	T-052-001	5a215c6a5e
Summary of Clinical Validation of Data Acquisition Digital Health Technology	T-200-001	5a215c6a5e

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

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