The following validation tests formed part of the validation test strategy to ensure that ApprovalFlow is fit for purpose for use in pharmaceutical companies and complies with the relevant regulatory requirements.

Functional testing

This type of test focuses on validating the software's functionality against specified requirements. It ensures that the software performs the intended operations accurately and consistently. Functional testing may involve verifying features such as data entry, calculations, report generation, and system interactions.

User Acceptance Testing (UAT)

UAT involves testing the software from an end-user perspective. It aims to ensure that the software meets the needs and expectations of the intended users. UAT is typically performed by users or representatives who validate the software's usability, user interface, and overall user experience.

Data Integrity Testing

This type of test focuses on verifying the accuracy, completeness, and consistency of data processed and stored by the software. It ensures that data remains intact and unaltered throughout the software's operations. Data integrity testing often involves validating data input, transformation, storage, and retrieval processes.

Performance Testing

Performance testing assesses the software's performance under expected and peak load conditions. It aims to validate the software's responsiveness, scalability, and stability. Performance testing may involve stress, load, and endurance testing to evaluate the software's performance and identify any bottlenecks or performance issues.

Security Testing

Security testing assesses the software's ability to protect sensitive data and prevent unauthorised access, manipulation, or data loss. It involves testing authentication mechanisms, access controls, encryption, audit trails, and other security features. Security testing helps ensure compliance with regulations like 21 CFR Part 11, emphasising data security and electronic record integrity.

Regulatory Compliance Testing

In the pharmaceutical industry, software systems must comply with various regulatory requirements, such as 21 CFR Part 11 and Good Documentation Practices (GDocP). Regulatory compliance testing involves validating that the software meets these specific regulations and guidelines, ensuring it provides the necessary controls and functionalities to maintain data integrity and security.

Validation Documentation

In addition to the actual tests, validation in the pharmaceutical context requires thorough documentation. This includes creating validation plans, test protocols, test scripts, and validation reports. These documents outline the validation strategy, test objectives, steps, acceptance criteria, and test results. They serve as evidence of compliance with regulatory requirements and provide a record of the validation process.

User Access Validation

• Test the user authentication and access control mechanisms of the system.
• Verify that only authorised users can log in and access the system.
• Test different user roles and permissions to ensure proper access restrictions are enforced.

Document Upload Validation

• Test the functionality to upload documents to the system.
• Verify that documents are uploaded successfully and stored in the appropriate location.
• Test various file formats to ensure compatibility and proper handling of different document types.

Document Versioning Validation

• Test the system's ability to manage document versions effectively.
• Verify that each document version is properly labeled, tracked, and stored.
• Test version control features such as checking out, editing, and checking in documents to ensure accurate version history.

Review and Approval Workflow Validation

• Test the workflow for document review and approval.
• Verify that documents move through the appropriate stages (e.g., draft, review, approval) as per the defined workflow.
• Test different scenarios, such as parallel or sequential reviews, to ensure proper routing and notifications.

Commenting and Collaboration Validation

• Test the functionality for users to add comments, annotations, and feedback on documents.
• Verify that comments are properly associated with specific document versions and can be tracked and resolved.
• Test collaboration features, such as notifying users of new comments and facilitating discussions.

Search and Retrieval Validation

• Test the system's search functionality to retrieve documents based on various criteria (e.g., document name, keywords, metadata).
• Verify that search results are accurate and relevant.
• Test advanced search capabilities, such as filtering and sorting options.

Audit Trail Validation

• Test the system's ability to generate and maintain an audit trail of document activities.
• Verify that all relevant actions (e.g., document uploads, approvals, comments) are logged with timestamps and user information.
• Test the retrieval and display of audit trail information for auditing purposes.

Performance and Scalability Validation

• Test the system's performance under normal and peak loads.
• Verify that the system can handle a significant number of documents and users without degradation in performance.
• Test scalability by simulating increased user and document volumes to ensure the system can handle future growth.

Disaster Recovery and Backup Validation:

• Test the system's disaster recovery and backup mechanisms.
• Verify that data can be restored in case of system failures or data loss.
• Test backup and restore procedures to ensure data integrity and availability.