R-001-001 Control of documents and records

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

Written by	Reviewed by
E-Signature (Appfire integration): Taig Mac Carthy 2A21910238D5D2AFF9D3BFA2919BDBF4 Signer name: Taig Mac Carthy Signing time: Sat, 10 Sep 2022 13:57:34 GMT Reason: Creation of document	E-Signature (Appfire integration): Alfonso Medela F777E10BCA710C748E44E7F531DA03BE Signer name: Alfonso Medela Signing time: Sun, 11 Sep 2022 13:56:42 GMT Reason: Reviewed
Quality manager (QM)	Technical manager (PRRC)

020 General Procedures (GP)

Name	Code	Approval date	Impact?	Version
Documents and records control	GP-001	20220413	No	7
Quality planning	GP-002	20220413	No	2
Internal audit	GP-003	20220413	No	2
Vigilance system	GP-004	20220413	No	2
Human resources and training	GP-005	20220413	No	2
Non-conformity. Corrective and preventive actions	GP-006	20220413	No	2
Post-market surveillance	GP-007	20220413	No	2
Product requirements	GP-008	20220413	No	2
Sales	GP-009	20220413	No	2
Purchases and suppliers evaluation	GP-010	20220413	No	2
Production and service provision	GP-011	20220413	No	2
Design, re-design and development	GP-012	20220413	No	2
Risk management	GP-013	20220413	No	2
Feedback and complaints	GP-014	20220413	No	2
Clinical evaluation	GP-015	20220413	No	2
Traceability and identification	GP-016	20220413	No	2
Technical Assistance Service	GP-017	20220413	No	2
Infraestructure and facilities	GP-018	20220923	No	3
Software validation	GP-019	20220413	No	2
Data analysis	GP-020	20220413	No	2
Communications	GP-021	20220413	No	2
Document translation	GP-022	20220413	No	2

021 Specific Procedures (SP)

Name	Code	Approval date	Impact?	Version
API onboarding	SP-009	20201120		1
Software development management	SP-012			1

Templates

Name	Code	Approval date	Impact?	Version	Reason for revision
Control of Documents and Records	T-001-001	20201120		1
Quality Objectives	T-002-001			1
Quality Indicators	T-002-002			1
Management Review Report	T-002-003			1
Internal Audit Schedule	T-003-001			1
Internal Auditor Qualification	T-003-002			1
Internal Audit Checklist	T-003-003			1
Internal Audit Report	T-003-004			1
FSN	T-004-001			1
FSCA	T-004-002			1
Trend report	T-004-003			1
Personnel Card	T-005-001			1
Training Plan	T-005-002			1
Training Report	T-005-003			1
New Employees initial training	T-005-004			1
Job description	T-005-005			1
Non conformity report	T-006-001			1
Communications Record	T-006-002			1
PSUR	T-007-001			1
Budget	T-009-001			1
API key delivery	T-009-002			1
Suppliers evaluation	T-010-001			1
Purchase order	T-010-002			1
Design Technical specifications	T-012-001			1
Design Planning	T-012-002			1
Design Inputs	T-012-003			1
Design Outputs	T-012-004			1
Design Review	T-012-005			1
Design Verification	T-012-006			1
Design Validation	T-012-007			1
Risk Management Plan	T-013-001			1
Risk Management Report	T-013-002			1
Requirements risks	T-013-003			1
Product risks	T-013-004			1
Processes risks	T-013-005			1
Infrastructure risks	T-013-006			1
Personnel Training risks	T-013-007			1
Complaints	T-014-001			1
Customer Satisfaction Survey	T-014-002			1
Clinical Evaluation Plan	T-015-001			1
Clinical Evaluation Report CER	T-015-002			1
Repairs file	T-017-001			1
Infrastructure control plan	T-018-001			1

Quality management and others

Name	Code	Approval date	Impact?	Version
Quality Manual	QM			1
Quality policy	Annex-01			1
Process map	Annex-02			1
Organization Chart	Annex-03			1
Technical File	TF-XXXX-YYYY-nn			1
Anexo-1 del Technical File	TF-XXXX-Annex-##-YYYY-nn			1