GxP Validation Option for the Web Interface
An organization with formal GxP validation requirements may need to review software changes and align its internal documentation, operating procedures, and training before introducing them to staff. The Files.com GxP validation option for the web interface gives your change-control team time to complete that work. It is available to customers with Enterprise Support for an additional charge.
GxP refers to good practice requirements in areas such as manufacturing, laboratory work, and clinical work. This option supports your organization's change-control process for the web interface. Your organization remains responsible for validating its intended use, configured workflows, and operating procedures.
We do not recommend this option for most customers. Our web interface is designed to remain intuitive as it evolves, and changes generally fit smoothly into everyday use. The standard release process delivers improvements and fixes as soon as we release them. This option is intended for the small number of customers whose formal requirements call for a separate review and approval process. We charge substantial additional costs for it, and your team takes on the work of reviewing and introducing updates.
Dated Versions and Upgrades
If you enable this paid capability, Files.com will preserve dated snapshots of the web application and its documentation. You will be able to select a dated application version and use documentation from the corresponding point in time, giving your team a stable reference for its procedures and validation work.
Your change-control team has time to review an updated interface, determine whether internal documentation or training needs to change, and approve and publish any revisions to align with the update. You will be able to select a newer snapshot when your team is ready to introduce its changes to staff, keeping the interface people use aligned with approved procedures and training.
By default, Files.com automatically upgrades the interface once every 90 days to a snapshot from 90 days before the upgrade. The selected snapshot remains fixed between automatic upgrades unless you choose a different version, providing a predictable interval for review and preparation. Because a default snapshot starts at 90 days old and ages through the next interval, an individual interface change can be delayed longer than 90 days.
Fixes and Security Updates
The review window also delays fixes. Older web-application snapshots receive no backported bug fixes or security updates. To obtain a fix to the web application, you must move to a newer snapshot that includes it. Keeping an older interface also keeps its existing defects and postpones improvements to its security protections.
Your change-control team must account for that delay when planning reviews and introducing updates, including when a fix makes an earlier upgrade necessary. This tradeoff is another reason we recommend the standard release process unless your formal requirements justify the additional control.
Scope of the Option
The option controls the web interface and provides dated documentation. The shared API and file-transfer services continue updating, and versions of the Desktop App, Mobile App, CLI, and SDKs are managed separately. Your validation and change-control process must account for those parts of your workflow as well.
As part of this option's GxP commitment, Files.com preserves API compatibility except when a security correction requires a breaking change. Security corrections to the shared service continue even when they require your organization to review or adjust a validated workflow.
Your team can pin SDK dependencies and control Desktop App updates through centralized deployment. Those controls govern the installed software; they do not prevent changes to the shared API or other cloud services.
Contact your Files.com account team to discuss the GxP validation option for the web interface, its additional cost, and whether it supports your organization's required review and approval process.