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21 CFR Release Schedule

Software Update Release Schedule for Regulated Industries

Charlene Morris avatar
Written by Charlene Morris
Updated over a year ago

Overview

A "release" refers to the process of updating the Limble software code that is used by our customers. These releases can contain new features, feature improvements, security updates, speed upgrades, and bug fixes. When there is a new release, the process is automatic and there is no interruption of service for the customer.

Limble has two release schedule options. This article details the two options.

Table of Contents

Continuous Release Schedule

Companies that do not need to comply with 21 CFR, or other regulations that require software validation, generally choose to be on the Continuous Release Schedule.

Customers on the Continuous Release schedule always have the latest version and get to benefit from the newest features.

6-Month Release Schedule (typically used for companies that need 21 CFR compliance)

This release schedule is more complex, as it is designed for companies who have very specific software release schedule needs. This option is only available for the Enterprise Plan and must be set up when the Limble account is created. It is not possible to change from one release schedule to another after creating a Limble account.

We recommend this option for companies that need to do testing on each software release, also known as software validation. This is typically dictated by the company's quality and risk management procedures.

Customers who choose the 6-Month Release schedule will receive a "validation account" that they can use for testing in addition to their "production account" that is used for normal Limble functions, such as maintaining assets, assigning tasks to team members, managing inventory, etc.

Here is what the release schedule looks like for an entire year:

  • April - The validation account is updated to be on the latest version of Limble. This is the same version that is currently on the Continuous Release schedule. Limble provides testing results from their internal validation to 21 CFR Part 11. The customer will have the entire month to test the new version of the software and create corresponding reports.

  • May - The customer's primary-use account is updated to the same Limble version as the validation account.

    • Keep in mind that from May to November Limble will not be changed or improved in any way.

  • October - The validation account is updated to be on the latest version of Limble. This is the same version that is currently on the Continuous Release schedule. Limble provides testing results from their internal validation to 21 CFR Part 11. The customer will have the entire month to test the new version of the software and create corresponding reports.

  • November - The customer's primary-use account is updated to the same Limble version as the validation account.

    • Keep in mind that from November to May Limble will not be changed or improved in any way.

Let us know if you have any questions. Regulatory and quality requirements can be involved and complex. We have trained team members on staff to help with any of your needs.

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