R-001-001 Control of documents and records_2023_001
- 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 |
| Written by | Reviewed by |
|---|---|
E-Signature (Appfire integration):  María Diez 2E77000A8D97E38740C5F98964BF2C12 Signer name: María Diez Signing time: Tue, 17 Jan 2023 12:12:08 GMT Reason: Creation of document | E-Signature (Appfire integration): Alfonso Medela 50FF6E21E8B480ABF75F8588CDEA0BD3 Signer name: Alfonso Medela Signing time: Wed, 18 Jan 2023 12:11:16 GMT Reason: Reviewed |
| Quality manager (QM) | Technical manager (PRRC) |
Quality management and others
| Name | Code | Approval date | Impact? | Version |
|---|---|---|---|---|
| Quality Manual | QM | 11/24/2020 | No | 1 |
| Quality policy | Annex-001 | 9/23/2022 | No | 2 |
| Process map | Annex-002 | 11/23/2022 | No | 1 |
| Organization Chart | Annex-003 | 11/29/2022 | No | 4 |
General and Specific Procedures (GP and SP)
| Name | Code | Approval date | Impact? | Version |
|---|---|---|---|---|
| Documents and records control | GP-001 | 12/22/2022 | No | 8 |
| Quality planning | GP-002 | 12/28/2022 | Yes* | 3 |
| Audits | GP-003 | 12/27/2022 | No | 3 |
| Vigilance system | GP-004 | 1/2/2023 | No | 3 |
| Human resources and training | GP-005 | 12/22/2022 | No | 3 |
| Non-conformity. Corrective and preventive actions | GP-006 | 12/22/2022 | No | 3 |
| Post-market surveillance | GP-007 | 1/3/2023 | No | 3 |
| Product requirements | GP-008 | 9/11/2022 | No | 2 |
| Sales | GP-009 | 9/11/2022 | No | 2 |
| API onboarding | SP-009-001 | 9/11/2022 | No | 2 |
| Purchases and suppliers evaluation | GP-010 | 9/11/2022 | No | 2 |
| Production and service provision | GP-011 | 9/11/2022 | No | 2 |
| Design, re-design and development | GP-012 | 9/11/2022 | No | 2 |
| Software development management | SP-012-001 | 9/11/2022 | No | 2 |
| Risk management | GP-013 | 9/11/2022 | No | 2 |
| Feedback and complaints | GP-014 | 12/13/2022 | No | 3 |
| Clinical evaluation | GP-015 | 9/11/2022 | No | 2 |
| Traceability and identification | GP-016 | 9/11/2022 | No | 2 |
| Technical Assistance Service | GP-017 | 9/11/2022 | No | 2 |
| Infraestructure and facilities | GP-018 | 9/11/2022 | No | 3 |
| Remote infrastructure control access policy | SP-018-001 | 9/11/2022 | No | 2 |
| Software validation | GP-019 | 9/11/2022 | No | 2 |
| Data analysis | GP-020 | 9/11/2022 | No | 2 |
| Communications | GP-021 | 9/11/2022 | No | 2 |
| Document translation | GP-022 | 9/11/2022 | No | 2 |
* 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.
Templates
| Name | Code | Approval date | Impact? | Version |
|---|---|---|---|---|
| Control of documents and records | T-001-001 | 1/18/2023 | No | 3 |
| Manufacturer declaration of conformity | T-001-002 | 9/23/2022 | No | 1 |
| Backup copies control | T-001-003 | 1/16/2023 | No | 2 |
| Backup integrity verification | T-001-004 | 1/16/2023 | No | 2 |
| Quality objectives list | T-002-001 | 12/28/2022 | No | 2 |
| Quality objectives | T-002-002 | 12/28/2022 | No | 2 |
| Quality indicators | T-002-003 | 12/28/2022 | No | 2 |
| Management review report | T-002-004 | 12/28/2022 | No | 2 |
| Quality calendar | T-002-005 | 12/28/2022 | No | 1 |
| SWOT and CAME analysis | T-002-006 | 12/29/2022 | No | 1 |
| Audits program | T-003-001 | 12/19/2022 | No | 1 |
| Internal auditor qualification | T-003-002 | 12/27/2022 | No | 2 |
| Internal audit plan | T-003-003 | 12/27/2022 | No | 2 |
| Internal audit checklist | T-003-004 | 12/28/2022 | No | 2 |
| Internal audit report | T-003-005 | 12/28/2022 | No | 2 |
| Job description | T-005-001 | 12/19/2022 | No | 2 |
| PMS plan | T-007-001 | 1/3/2023 | No | 1 |
| PMCF plan | T-007-002 | 1/4/2023 | No | 1 |
| PSUR | T-007-003 | 1/5/2023 | No | 1 |
| PMS evaluation report | T-007-004 | 1/9/2023 | No | 1 |
| PMCF evaluation report | T-007-005 | 1/4/2023 | No | 1 |
| Sanitary alerts databases | T-007-006 | 1/4/2023 | No | 1 |
| Suppliers evaluation | T-010-001 | 11/24/2022 | No | 1 |
Data protection
| Name | Code | Approval date | Impact? | Version |
|---|---|---|---|---|
| Data controller manual | DP-001-000 | 9/23/2022 | No | 1 |
| Data protection officer manual | DP-002-000 | 9/23/2022 | No | 1 |
| Security violations | DP-003-000 | 1/18/2023 | Yes* | 3 |
| First layer of information in digital environments | Annex DP-002-000 | 9/23/2022 | No | 1 |
| Review API events logs | T-DP-003-001 | 1/17/2023 | No | 1 |
| Review defined security groups | T-DP-003-002 | 1/18/2023 | No | 1 |
| EC2 instances review | T-DP-003-003 | 1/17/2023 | No | 1 |
| Information clause on the processing of personal data in contracts (processors) | No | 1 | ||
| Information clause on the processing of personal data in contracts (controllers) | No | 1 | ||
| Employee data modification | No | 1 | ||
| Employee recruitment | No | 1 | ||
| Footer for email | No | 1 | ||
| Email footer for advertising purposes | No | 1 | ||
| Privacy policy | No | 1 | ||
| Release of image rights | No | 1 |
* 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.