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Glossary

This glossary defines terms related to Opentrons Flex Compliance Ready Software. As you read the manual, words in italics indicate terms that are defined in this glossary.

21 CFR part 11

Part of the Code of Federal Regulations under Chapter I (Food and Drug Administration), Subchapter A, and part 11, pertaining to electronic records and electronic signatures.

Admin account

Each lab needs at least one compliance ready account assigned an administrator role. These accounts have full system access and can update administrator and Flex system settings. By default, only these accounts can manage protocols on the Flex.

Audit logs

Files containing protocol and Compliance Ready Software data, like user actions and their documentation, protocol run logs, and other robot data. Your compliance ready Flex stores these logs temporarily and will prompt you to download them when the robot nears its storage capacity.

Documentation

Text added by users in an open prompt in the Opentrons App or on the Flex touchscreen to explain their reason for completing an action, like running a protocol or updating a setting on their compliance ready Flex.

Encryption key

A three-word string, generated by your Flex every 30 seconds. Access the encryption key from the Flex touchscreen and enter it into your Opentrons App to establish (or re-establish) the connection between your compliance ready Flex and app.

Period

Audit logs are grouped together by period for download from the Opentrons App or Flex touchscreen. Log periods end when the robot boots, like after a robot software update, or when the Flex complates a protocol run.

Protocol run history

A list of protocols run by any Flex, including run date, protocol title, status (canceled, failed, or completed), associated files, and run duration.

Protocol run record

Additional details about each protocol run listed in your Flex's run history, including selected parameters, timestamps, run time, images taken during the run, and more.

Recovery account

A single recovery account is created during software activation. Your lab should save this account's automatically generated username and password in case you're locked out of all other compliance ready accounts.

Recovery service

If your lab loses access to all administrator accounts and your recovery account, contact Opentrons for a paid, on-site recovery service. This service restores access and preserves existing files from your Flex.

Service account

An account created on your compliance ready Flex during software activation. Opentrons-trained representatives can log into this account for maintenance, service, or to restore locked accounts.

Service PIN

A PIN provided by an Opentrons-trained representative and used to activate Opentrons Flex Compliance Ready Software. Your lab will never need to access this PIN again.

User account

Day-to-day users of the Flex are assigned this role in Compliance Ready Software. They can't configure administrator settings and, by default, can't manage protocols on the Flex.