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 |
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 |
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