User Requirements Specifications (URS).

Typical content would include:

• Purpose of the document and overview of the project or system.

• Clearly defined scope boundaries of the project or system with inclusions and exclusion.

• Identification of the regulatory requirements the system must comply with (e.g., cGMP, cGLP, OGTR, DAFF, etc.).

• Description of specific requirements with input from end-users such as production, quality control, and regulatory affairs.

• Description of the desired functions of the project and how it should perform under various conditions.

• Criteria for the project’s performance, including accuracy, reliability, and speed and requirements for data integrity and security.

• Standards for product quality and compliance with industry regulations and the requirements for record-keeping.

• Interaction with other systems or equipment and compatibility requirements.

• Specification of training needs for personnel who will be using the project.

• Requirements for ongoing maintenance and support of the system with procedures for troubleshooting and issue resolution.

• Criteria and procedures for system validation and verification with protocols for testing and acceptance criteria.

• Procedures for handling changes to the project and the documentation requirements for change requests.