The Customer must provide the following information to NOTOCORD at the specified stages listed below:
Prior to phase 1 (UVA10a):
- Customer stakeholders and main contact information,
- Customer’s experimental protocols used for the validated system (e.g.: number of animals, acquisition duration, analysis protocol, relevant data, etc…),
- Quality Assurance internal rules and constraints (linked to the validation project).
Prior to phase 2 (UVA10b):
- Change Control form, including a description of the changes and an authorization for the upgrade-related actions,
- Signature log defining the roles and responsibilities of each participant, including the printed name, signature, initials and the date of the signature,
- List of applicable FDA and EU regulations,
- Data and configuration files used as reference for the previous validated software version,
- Microsoft Excel® spreadsheet used as reference for the previous validated software version,
- All scientific details and procedures for scientific tests,
- Applicable IQ document completed during the previous validated software version installation,
- List of applicable SOPs (e.g. Disaster recovery, Change Control management, scientific research procedures, etc.).
- List of all NOTOCORD-hem authorized users, work groups, and their assigned privileges and roles.