# Documents check-list for Autoseq CE-IVDR certification

## 1. Quality Management System (QMS) Documentation:

### Quality Manual:
A document that describes your organization's quality management system and how it complies with the CE-IVDR requirements.
### Standard Operating Procedures (SOPs):
Documented procedures for various processes within your organization, including development, testing, validation, and maintenance of the autoseq pipeline.

#### Some of the SOPs that will be included in a bioinformatics QMS include:

**Data management:** SOPs for data collection, storage, backup, and archiving to ensure data integrity and accessibility. This will include procedures for data curation, versioning, and data sharing with other researchers.

**Quality control:** SOPs for quality control and validation of data, including procedures for data cleaning, error checking, and data formatting. This will include procedures for data validation, data quality assurance, and data quality control.

**Analysis:** SOPs for bioinformatics analysis, including procedures for sequence alignment, gene expression analysis, and other bioinformatics workflows. This will include procedures for data analysis, data processing, and data interpretation.

**Software and hardware:** SOPs for software and hardware installation, maintenance, versioning on git and management to ensure that all systems are up to date and working properly. This will include procedures for software installation, software validation, and software maintenance.

**Data security:** SOPs for data security and access control, including procedures for data encryption, access permissions, and data sharing. This will include procedures for data security, data protection, and data privacy.

**Compliance:** SOPs for compliance with regulatory requirements, including procedures for data governance, data integrity, and data security.

**Auditing:** SOPs for internal and external auditing of data, analysis, and other bioinformatics processes to ensure compliance with regulatory requirements and the organization's policies.

**Training:** SOPs for training of personnel on bioinformatics QMS processes, procedures, and compliance requirements.

## 2. Design and Development Documentation:

### Software Requirements Specification (SRS):
A detailed document that specifies the functional and non-functional requirements of the software.

### Software Architecture Design:
Detailed design documentation that describes the software's architecture, components, and interfaces.

### Risk Management Plan:
Documentation outlining how you identify, assess, and mitigate risks associated with software development and usage.

### Traceability Matrix:
A document that shows the relationship between the requirements, design elements, and test cases, demonstrating full traceability.

## 3. Validation and Verification Documentation:

### Validation Plan and Report:
Documents outlining how you plan and execute the validation process to ensure the software performs as intended.

### Verification Plan and Report:
Documents outlining how you plan and execute the verification process to ensure the software meets its specified requirements.

### Test Protocols and Test Reports:
Detailed test plans and reports for various testing phases, including unit testing, integration testing, system testing, and user acceptance testing.

## 4. Regulatory Compliance Documentation:

### CE-IVDR Conformity Assessment:
Documentation demonstrating how your software complies with the CE-IVDR requirements.

### Technical File:
A compilation of all documentation, including design, validation, and risk assessment, required to demonstrate compliance with CE-IVDR.

### Declaration of Conformity:
A formal document declaring your product's compliance with CE-IVDR regulations.

## 5. Change Control and Version Management:

### Change Control Procedures:
Documentation outlining how changes to the software are managed, including versioning, testing, and validation of changes.

### Release Notes:
Documentation detailing the changes made in each software release.

## 6. User Documentation:

### User Manuals:
Manuals or guides for end-users explaining how to install, configure, and use the autoseq pipeline.

### Training Materials:
Documentation for training end-users and operators.

## 7. Audit Trail and Logging Documentation:

### Audit Trail Records:
Documentation of all actions taken within the software, including user access and system events.

### Logging Procedures:
Documentation outlining how logs are generated, stored, and reviewed for compliance and troubleshooting.

## 8. Complaint Handling and Adverse Event Reporting:

### Complaint Handling Procedures:
Documentation on how user complaints and issues are handled and investigated.

### Adverse Event Reporting:
Procedures for reporting adverse events or incidents related to the use of the autoseq pipeline.

## 9. Data Security and Privacy Documentation:

### Data Protection Impact Assessment (DPIA):
Documentation outlining how you assess and mitigate risks related to data protection and privacy.

### Security Measures:
Documentation of security measures in place to protect user data and the pipeline itself.

## 10. Maintenance and Support Documentation:

### Maintenance Plans:
Documentation outlining how you plan to maintain and update the software.

### Support Procedures:
Documentation describing how support requests are handled and resolved.

## 11. Records and Document Control:

### Document Control Procedures:
Procedures for creating, reviewing, approving, and maintaining documents.
### Record Keeping:
Procedures for maintaining records of all activities related to the autoseq pipeline.

## 12. Training Records:

### Training Records:
Records of training provided to personnel involved in the development, maintenance, and support of the autoseq pipeline.

## 13. Supplier and Subcontractor Documentation:

### Supplier Agreements:
Documentation of agreements with suppliers or subcontractors, including software component suppliers.

## 14. Regulatory Submissions:

### CE-IVDR Submission Documents:
Documents required for the CE-IVDR certification process, including the technical documentation required for review by a Notified Body.

### CAPA (Corrective and Preventive Actions) Documentation:

CAPA Procedures and Records: Procedures for identifying, addressing, and preventing issues or non-compliance.