R-001-001 Control of documents and records 2023_002

• Governed by GP-001 Document and Registry Control
• Comes from template T-001-001

Version control

Reason for review	Date	Version id
First version	20220910	1
Document adapted to new QMS	20230116	2
Data protection section included	20230118	3
Data protection documents codification updated and included within the other documents	20230307	4

Written by	Reviewed by
E-Signature (Appfire integration): María Diez D810830658F3B445FB634F7F8A7581CB Signer name: María Diez Signing time: Mon, 06 Mar 2023 08:10:50 GMT Reason: Creation of document	E-Signature (Appfire integration): Alfonso Medela F828436F64D417F854A46D0B5A9DB449 Signer name: Alfonso Medela Signing time: Tue, 07 Mar 2023 08:09:58 GMT Reason: Reviewed
Quality manager (QM)	Technical manager (PRRC)

Quality management and others

Name	Code	Approval date	Impact?	Version
Quality Manual	QM	20220911	No	6
Quality policy	Annex-001	20230217	No	3
Process map	Annex-002	20221123	No	1
Organization Chart	Annex-003	20230203	No	5

General and Specific Procedures (GP and SP)

Name	Code	Approval date	Impact?	Version
Documents and records control	GP-001	20230216	No	10
Quality planning	GP-002	20221228	Yes*	3
Audits	GP-003	20221227	No	3
Vigilance system	GP-004	20230102	No	3
Human resources and training	GP-005	20221222	No	3
Non-conformity. Corrective and preventive actions	GP-006	20221222	No	3
Post-market surveillance	GP-007	20230103	No	3
Product requirements	GP-008	20220911	No	2
Commercial and sales	GP-009	20220911	No	2
API onboarding	SP-009-001	20220911	No	2
Purchases and suppliers evaluation	GP-010	20220911	No	2
Production and service provision	GP-011	20220911	No	2
Design, re-design and development	GP-012	20230306	No	4
Software development management	SP-012-001	20220911	No	2
Risk management	GP-013	20230203	No	3
Feedback and complaints	GP-014	20221213	No	3
Clinical evaluation	GP-015	20230221	No	3
Traceability and identification	GP-016	20220911	No	2
Technical Assistance Service	GP-017	20220911	No	2
Infraestructure and facilities	GP-018	20220911	No	3
Remote infrastructure control access policy	SP-018-001	20220911	No	2
Software validation	GP-019	20220911	No	2
Data analysis	GP-020	20220911	No	2
Communications	GP-021	20220911	No	2
Document translation	GP-022	20220911	No	2
Data protection	GP-050	20220911	No	1
Data protection officer manual	DP-050-001	20220911	No	1
Security violations	DP-051-001	20230118	Yes**	3
First layer of information in digital environments	Annex DP-050	20220923	No	1
Information clause on the processing of personal data in contracts (processors)	T-DP		No	1
Information clause on the processing of personal data in contracts (controllers)	T-DP		No	1
Employee data modification	T-DP		No	1
Employee recruitment	T-DP		No	1
Footer for email	T-DP		No	1
Email footer for advertising purposes	T-DP		No	1
Privacy policy	T-DP		No	1
Release of image rights	T-DP		No	1

* The implementation of the change in the procedure has led to the creation of new templates and records to ensure compliance and registration of the new activities described above.

** The implementation of the change in the DP-003 procedure has led to the creation of 3 new templates and records to ensure compliance and registration of the new activities described above.

Templates

Name	Code	Approval date	Impact?	Version
Control of documents and records	T-001-001	20230307	No	4
Manufacturer declaration of conformity	T-001-002	20230306	No	8
Backup copies control	T-001-003	20230116	No	2
Backup integrity verification	T-001-004	20230116	No	2
List of external documents	T-001-005	20230125	No	1
Quality objectives list	T-002-001	20221228	No	2
Quality objectives	T-002-002	20221228	No	2
Quality indicators	T-002-003	20230214	No	3
Management review report	T-002-004	20221228	No	2
Quality calendar	T-002-005	NA	No
SWOT and CAME analysis	T-002-006	20221229	No	1
Audits program	T-003-001	20221219	No	1
Internal auditor qualification	T-003-002	20221227	No	2
Internal audit plan	T-003-003	20221227	No	2
Internal audit checklist	T-003-004	20221228	No	2
Internal audit report	T-003-005	20221228	No	2
Job description	T-005-001	20221219	No	2
PMS plan	T-007-001	20230104	No	1
PMCF plan	T-007-002	20230104	No	1
PSUR	T-007-003	20230105	No	1
PMS evaluation report	T-007-004	20230109	No	1
PMCF evaluation report	T-007-005	20230104	No	1
Sanitary alerts databases	T-007-006	20230104	No	1
Implementation plan	T-009-001	20230306	No	1
Suppliers evaluation	T-010-001	20221124	No	1
Customers product version control	T-012-012	20230306	No	2
Risk Management Plan	T-013-001	20230207	No	1
Risk Management Report	T-013-003	20230207	No	1
Customer Satisfaction Survey	T-014-001	20230206	No	1
Clinical Evaluation Plan	T-015-001	20230227	No	1
Clinical Evaluation Report CER	T-015-003	20230227	No	1
Infrastructure and facilities incidents log	T-018-002	20230118	No	1
Processing activities (ROPA)	T-DP-050-001	20220911	No	1
API events logs	T-DP-051-001	20230117	No	1
Security groups	T-DP-051-002	20230118	No	1
EC2 instances	T-DP-051-003	20230117	No	1