Glossary Term
Version Control
Definition
Version control is a system used to manage and track changes made to documents, software, or other types of content over time. In the MedTech industry, version control refers to the process of managing and documenting changes made to medical device documentation, design files, software, and other product-related materials. This ensures that every modification is recorded, previous versions can be accessed, and a history of changes is maintained for regulatory compliance, quality assurance, and traceability. By using version control, companies can ensure that the latest approved version of a document or product design is in use, and that any changes are tracked and traceable for audit purposes.
Relevance to the MedTech Industry
In the MedTech industry, version control is essential for maintaining the integrity, safety, and compliance of medical devices throughout their lifecycle. Regulatory bodies like the FDA, EMA, and ISO 13485 require that manufacturers maintain accurate records of all changes to device design, testing protocols, manufacturing processes, and quality documentation. Version control helps manufacturers ensure that the most current versions of documents, designs, and software are used in product development, while also providing a clear history of changes for future audits, regulatory submissions, and post-market surveillance. Proper version control ensures that updates or corrections are made systematically, and that all stakeholders are working with the correct versions of critical documents.
Additional Information & Related Terms
Key Features of Version Control in MedTech
Centralized Repository:A version control system stores all versions of documents, designs, and software in a centralized location. This allows users to access historical versions of files, compare changes, and retrieve previous iterations when necessary.
Example: A medical device company stores its design files and software code in a version control system, allowing engineers to access previous versions of the software and understand how it has evolved.
Change Tracking:Version control tracks changes made to documents or software, recording who made the change, when it was made, and a description of the modification. This provides transparency and accountability in the development and documentation process.
Example: When an engineer updates the firmware of a pacemaker, the version control system logs the date and time of the change, along with notes explaining the purpose of the update (e.g., fixing a bug or enhancing battery life).
Branching and Merging:In software development, version control allows teams to create branches of the code for testing and development. These branches can later be merged into the main codebase once the changes have been validated. This allows for experimentation and testing without affecting the main product.
Example: A development team working on a software update for a diabetes management system creates a branch in the version control system to test new features, then merges the updated code back into the main version once the changes are validated and approved.
Audit Trail:A version control system provides a detailed audit trail, which is essential for regulatory compliance. It ensures that all changes are documented, including who authorized and implemented them, and provides a clear history for future inspections or audits.
Example: During a regulatory audit, a medical device manufacturer uses the version control system’s audit trail to show how design files have evolved and demonstrate that all changes were made in compliance with regulatory requirements.
Collaborative Access:Version control systems allow multiple users to collaborate on the same document or design file, ensuring that everyone is working on the latest version. It helps prevent errors that might occur from using outdated versions or conflicting changes.
Example: A cross-functional team working on a new surgical tool can simultaneously collaborate on design files using version control, ensuring that the latest updates are available to all team members.
Related Terms
Change Control: A formal process for managing and documenting changes to products, processes, or systems to ensure that the changes do not negatively affect quality, safety, or compliance.
Document Management System: A system used to track, manage, and store documents, often integrating with version control systems to maintain a historical record of document revisions.
Software Configuration Management: A subset of version control, it specifically focuses on managing changes to software code, tracking versions, and maintaining the integrity of the software product.
Audit Trail: A chronological record of changes made to a document or system, often used for compliance, regulatory, and security purposes.