R-001-001 Control of documents

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

Quality management and others

Name	Code	Approval date	Version	History
Quality Manual	QM	2024-10-23	2ab9b29	QM History
Quality policy	Annex-001	2024-11-14	b7c9d43	Annex-001 History
Process map	Annex-002	2024-11-13	bda3b84	Annex-002 History
Substitution table	Annex-004	2024-11-15	12950cb	Annex-004 History

General and Specific Procedures (GP and SP)

Name	Code	Approval date	Version	History
Documents and records control	GP-001	2024-11-13	bda3b84	GP-001 History
eIFU management	SP-001-001	2024-11-14	b7c9d43	SP-001-001 History
Quality planning	GP-002	2024-11-14	b7c9d43	GP-002 History
Audits	GP-003	2024-11-14	b7c9d43	GP-003 History
Vigilance system	GP-004	2024-11-14	b7c9d43	GP-004 History
Product Withdrawal	SP-004-001	2024-10-23	8f8f6ba	SP-004-001 History
Human resources and training	GP-005	2024-11-15	b6ee152	GP-005 History
Anti-corruption and anti-bribery	SP-005-001	2024-11-14	b7c9d43	SP-005-001 History
Non-conformity. Corrective and preventive actions	GP-006	2024-11-14	b7c9d43	GP-006 History
Post-market surveillance	GP-007	2024-11-13	bda3b84	GP-007 History
Product requirements	GP-008	2025-01-13	4f78009	GP-008 History
Sales	GP-009	2025-01-13	c479d55	GP-009 History
How to use the CRM	SP-009-001	2024-10-23	8f8f6ba	SP-009-001 History
Contracts	SP-009-002	2024-11-13	bda3b84	SP-009-002
How to share performance metrics	SP-009-003	2024-10-23	8f8f6ba	SP-009-003
Purchases and suppliers evaluation	GP-010	2024-11-14	b7c9d43	GP-010 History
Provision of service	GP-011	2024-11-14	b7c9d43	GP-011 History
Design, re-design and development	GP-012	2024-11-13	bda3b84	GP-012 History
Cybersecurity and transparency requirements	SP-012-002	2024-10-23	8f8f6ba	SP-012-002
Predetermined Change Control Plan	SP-012-003	2025-01-07	44a46f6	SP-012-003
Risk management	GP-013	2024-11-14	b7c9d43	GP-013 History
Feedback and complaints	GP-014	2024-11-14	b7c9d43	GP-014 History
Clinical evaluation	GP-015	2024-11-14	b7c9d43	GP-015 History
Traceability and identification	GP-016	2024-11-14	b7c9d43	GP-016 History
Technical Assistance Service	GP-017	2024-11-14	b7c9d43	GP-017 History
Infrastructure and facilities	GP-018	2024-11-14	b7c9d43	GP-018 History
Remote infrastructure control access policy	SP-018-001	2024-11-14	b7c9d43	SP-018-001 History
Software validation	GP-019	2025-01-02	65df628	GP-019 History
QMS Data analysis	GP-020	2024-11-14	b7c9d43	GP-020 History
Communications	GP-021	2024-11-13	bda3b84	GP-021 History
Document translation	GP-022	2024-11-14	b7c9d43	GP-022 History
Change control management	GP-023	2024-11-14	b7c9d43	GP-023 History
Product requirements for US market	GP-026	2025-01-07	44a46f6	GP-026 History
Product requirements for UK market	GP-027	2025-01-07	2816db0	GP-027 History
Product requirements for the Brazilian market	GP-028	2025-01-07	b03cf95	GP-028 History
Data protection	GP-050	2024-11-14	b7c9d43	GP-050 History
Data protection officer manual	SP-050-001	2024-11-14	b7c9d43	SP-050-001 History
Manual of functions and obligations of the staff	SP-050-002	2024-11-14	b7c9d43	SP-050-002 History
Data sharing	SP-050-003	2024-11-14	b7c9d43	SP-050-003 History
Security violations	GP-051	2024-11-14	b7c9d43	GP-051 History
Data Privacy Impact Assesment (DPIA)	GP-052	2024-11-13	bda3b84	GP-052 History
Business continuity and disaster recovery plans	GP-100	2024-11-14	b7c9d43	GP-100 History
Information security	GP-101	2024-11-14	b7c9d43	GP-101 History
Remote Data Acquisition in Clinical Investigations	GP-200	2024-11-29	c6d587e	GP-200 History

Templates

Name	Code	Approval date	Version	History
Control of documents	T-001-001	2024-11-14	b7c9d43	T-001-001 History
Manufacturer declaration of conformity_MDD	T-001-002	2024-11-14	b7c9d43	T-001-002 History
List of external documents	T-001-005	2024-11-14	b7c9d43	T-001-005 History
IFU and label validation	T-001-006	2024-11-14	b7c9d43	T-001-006 History
Manufacturer declaration of conformity_MDR	T-001-007	2024-11-14	b7c9d43	T-001-007 History
Device name labeling	T-001-008	2024-11-14	b7c9d43	T-001-008 History
Training on procedures of the QMS	T-001-009	2024-11-14	b7c9d43	T-001-009 History
Quality objectives list	T-002-001	2024-11-14	b7c9d43	T-002-001 History
Quality objectives	T-002-002	2024-11-14	b7c9d43	T-002-002 History
Quality indicators	T-002-003	2024-11-14	b7c9d43	T-002-003 History
Annual management review report	T-002-004	2024-11-14	b7c9d43	T-002-004 History
Quality calendar	T-002-005	2024-11-14	b7c9d43	T-002-005 History
SWOT and CAME analysis	T-002-006	2024-11-14	b7c9d43	T-002-006 History
Process validation card	T-002-007	2024-11-14	b7c9d43	T-002-007 History
Regulatory requirements review report	T-002-009	2024-11-14	b7c9d43	T-002-009 History
Audits program	T-003-001	2024-10-23	c92b173	T-003-001 History
Internal auditor qualification	T-003-002	2024-10-23	c92b173	T-003-002 History
Internal audit plan	T-003-003	2024-10-23	c92b173	T-003-003 History
Internal audit checklist	T-003-004	2024-10-23	c92b173	T-003-004 History
Internal audit report	T-003-005	2024-10-23	c92b173	T-003-005 History
Withdrawal record	T-004-001	2024-10-23	c92b173	T-004-001 History
Job description	T-005-001	2024-10-23	c92b173	T-005-001 History
Training plan	T-005-003	2024-10-23	c92b173	T-005-003 History
Training evaluation and record	T-005-004	2024-10-23	c92b173	T-005-004 History
GDPR training	T-005-006	2024-11-13	bda3b84	T-005-006 History
Technical Responsible designation	T-005-007	2024-10-23	c92b173	T-005-007 History
PRRC designation	T-005-008	2024-10-23	c92b173	T-005-008 History
QMS procedures training	T-005-009	2024-11-13	bda3b84	T-005-009 History
Email footer generator	T-005-010	2024-11-13	bda3b84	T-005-010 History
PMS plan	T-007-001	2024-11-13	bda3b84	T-007-001 History
PMCF plan	T-007-002	2024-11-13	bda3b84	T-007-002 History
PSUR	T-007-003	2024-10-23	c92b173	T-007-003 History
PMS evaluation report	T-007-004	2024-10-23	c92b173	T-007-004 History
PMCF evaluation report	T-007-005	2024-10-23	c92b173	T-007-005 History
Sanitary alerts databases	T-007-006	2024-10-23	c92b173	T-007-006 History
GSPR	T-008-001	2024-10-23	c92b173	T-008-001 History
Implementation plan	T-009-001	2024-10-23	c92b173	T-009-001 History
Quotation for API	T-009-002	2024-10-23	c92b173	T-009-002 History
Terms of service and licensing agreement	T-009-003	2024-10-23	c92b173	T-009-003 History
Quotation for Clinical Trials	T-009-004	2024-10-23	c92b173	T-009-004 History
Suppliers evaluation	T-010-001	2024-10-23	c92b173	T-010-001 History
API key order	T-011-001	2024-10-23	c92b173	T-011-001 History
API key delivery	T-011-002	2024-11-14	b7c9d43	T-011-002 History
DeepLink and App keys order	T-011-003	2024-10-23	c92b173	T-011-003 History
DeepLink and App keys delivery	T-011-004	2024-11-14	b7c9d43	T-011-004 History
Requirements	T-012-001	2024-11-14	b7c9d43	T-012-001 History
Test run	T-012-003	2024-11-14	b7c9d43	T-012-003 History
Software version release	T-012-004	2024-11-13	bda3b84	T-012-004 History
Design change control	T-012-005	2024-11-13	bda3b84	T-012-005 History
Life cycle plan and report	T-012-006	2024-11-13	bda3b84	T-012-006 History
Formative evaluation plan	T-012-007	2024-11-13	bda3b84	T-012-007 History
Formative evaluation report	T-012-008	2024-11-13	bda3b84	T-012-008 History
Validation and testing of machine learning models	T-012-009	2024-11-13	bda3b84	T-012-009 History
Device back up verification	T-012-010	2024-11-13	bda3b84	T-012-010 History
Customer product version control	T-011-002	2024-11-14	b7c9d43	T-011-002 History
Summative evaluation plan	T-012-014	2024-11-13	bda3b84	T-012-014 History
Summative evaluation report	T-012-015	2024-11-13	bda3b84	T-012-015 History
Software usability test guide	T-012-016	2024-11-13	bda3b84	T-012-016 History
Integration test review	T-012-017	2024-11-13	bda3b84	T-012-017 History
Test plan	T-012-018	2024-11-14	b7c9d43	T-012-018 History
SOUP	T-012-019	2024-11-13	bda3b84	T-012-019 History
Predetermined Change Control Plan	T-012-020	2025-01-07	44a46f6	T-012-020 History
Risk Management Plan	T-013-001	2024-10-23	c92b173	T-013-001 History
Risk Management Record	T-013-002	2024-10-23	c92b173	T-013-002 History
Risk Management Report	T-013-003	2024-10-23	c92b173	T-013-003 History
Customer Satisfaction Survey	T-014-001	2024-11-14	b7c9d43	T-014-001 History
Clinical Evaluation Plan	T-015-001	2024-11-14	b7c9d43	T-015-001 History
Preclinical and clinical evaluation record	T-015-002	2024-10-23	c92b173	T-015-002 History
Clinical Evaluation Report CER	T-015-003	2024-11-14	b7c9d43	T-015-003 History
Clinical investigation plan	T-015-004	2024-11-14	b7c9d43	T-015-004 History
Investigator's brochure	T-015-005	2024-12-16	b1fd2f2	T-015-005 History
Clinical investigation report	T-015-006_EN	2024-11-13	bda3b84	T-015-006_EN History
Clinical investigation report	T-015-006_es	2024-10-23	c92b173	T-015-006_es History
Declaration of interest Clinical evaluation team	T-015-007	2024-10-23	c92b173	T-015-007 History
Clinical development plan	T-015-008	2024-11-14	b7c9d43	T-015-008 History
Clinical Investigation Plan_Study code_en	T-015-009	2024-11-14	b7c9d43	T-015-009 History
Infrastructure list and control plan	T-018-001	2024-11-14	b7c9d43	T-018-001 History
Infrastructure and facilities incidents log	T-018-002	2024-10-23	c92b173	T-018-002 History
Software validation report	T-019-001	2024-10-23	c92b173	T-019-001 History
External software list	T-019-002	2024-10-23	c92b173	T-019-002 History
Trend report	T-020-001	2024-11-14	b7c9d43	T-020-001 History
Change control	T-023-001	2024-10-23	c92b173	T-023-001 History
Pre-submission meeting request	T-026-001	2025-01-07	44a46f6	T-026-001 History
Processing activities (ROPA)	T-050-001	2024-11-14	b7c9d43	T-050-001 History
Data access key	T-050-003	2024-11-14	b7c9d43	T-050-003 History
API event logs	T-051-001	2024-11-14	b7c9d43	T-051-001 History
Security groups	T-051-002	2024-11-14	b7c9d43	T-051-002 History
EC2 instances	T-051-003	2024-11-14	b7c9d43	T-051-003 History
DPIA	T-052-001	2024-10-23	c92b173	T-052-001 History
Summary of Clinical Validation of Data Acquisition Digital Health Technology	T-200-001	2024-12-16	470eb7a	T-200-001 History

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, JD-004
• Approver: JD-001