Title 21 CFR Part 11 of the Code of Federal Regulations

Jonathan Gross avatar
Written by Jonathan Gross
Updated over a week ago

Labguru Confirms to the 21CFR#11 requirements in the following :

  1. Closed System - Labguru requires a unique user name and password to login - thus confirm to the definition of a 'closed system'. User roles and permissions allow further control to limit access only to relevant records. 

  2. Training and Support - To ensure end users understand the use of the electronic notebook and other parts of the system Labguru provides an online training module. 

  3. Password Policy * -  Labguru maintains a strict password policy to ensure it is not easy to gain unauthorized access ,by default - users are required to change password every 3 months (unless the organization requires a different method). by default - users are locked out of the system after 5 failed password attempt

  4. Electronic Records - Labguru considers Experiments, Protocols , Document - 21CFR#11 compliant documents as they are signable.

  5. Electronic Signature - 21Part#11 record require a two person signature (signature and witnessing). Once a record is signed and witness Labguru will auto-generate a PDF version locking the date of the signature and all associated assets with that signature. 

  6. Audit Trail - Labguru maintains an audit trail (https://my.labguru.com/audit_trail) to all system records - every change to the system is logged in a 'histories' table - thus confirming to the requirement of maintaining an audit trial. Each audit-trail entry is time stamped - we record the data transferred to the system and the user sending the request. 

  7. Retention of records - with according to our SPA - Labguru will retain all system records.  It is an internal policy of the customer to establish an SOP and risk assessments to the duration of the records that needs to be maintained. When deleting a record from the system - Labguru will soft delete (keeping a copy in the database but not presenting it to the end user), this allows full recover of data captured in the system. Versioning - on each save the system generates a new version allowing to review editing history.

  8. Copies of Records - Labguru supports FDA requirement by allowing exporting of records in the formats of PDF. We also allow periodic download of all system records (as xlsx, PDF) to ensure data availability

*With companies that use LDAP - labguru will not be responsible for maintaining password policy. 

It is understood that while labguru takes all the efforts to maintain and support 21CFR#11 compatibility it is the responsibility of the customer to ensure and validate that the system confirms to the regulatory requirements and meets its own specific needs.

You can read more about our privacy policy here.

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