FDA CFR21 part 11: Electronic signature - LabCollector

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FDA CFR21 part 11: Electronic signature

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SUMMARY:

LabCollector allows to assist with compliancy options. You can be more complaint with regulatory bodies like FDA, ISO, etc. To have more options for compliancy you need to purchase the compliancy pack. LabCollector, ELN and LSM add-ons all offer audit trail logs where you can always track any editions done to the records and also the ability to electronically sign them. 

Warning
Everything with compliancy in LabCollector comes ONLY when you purchase a Compliancy pack.

Everything with compliancy in Electronic Lab Notebook comes ONLY when ELN signature options is activated.

 

Please see how the below points required by FDA & how LabCollector, ELN & LSM can assist in abiding with them:

1. Should contains unique user ID & password

2. During signing password should be only known by the user

3. Meaning of signature (author & reviewer/approver) should be displayed during signature

4. Electronic signature should show the signer’s full printed name, to show the time and date of execution

5. The signed record should be locked from editing and deletion.

6. Electronic records must be maintained and linked to signatures for the life of the electronic record

1. Should contains unique user ID & password

LabCollector

ELN

LSM

LabCollector

  1. You can only connect one user with one user level permission in LabCollector.
    *Please read the Knowledge Base User level permission.
  2. In LabCollector ADMIN -> MANAGE USERS you can create each user and give them user level permission individually, that creates a unique ID for each user along with precise user login and password.
    *Please read the Knowledge Base on how to manage users.

  3. You cannot create several users with same user ID as LabCollector allots specific ID for each user.

ELN / LSM

 

2. During signing password should be only known by the user

LabCollector

ELN

LSM

  1. In LabCollector you can add a member of the ADMIN -> MANAGE LAB MEMBERS
  2. Superadmin can then give the member the required user level permission and a temporary password that the member can login with. The password encryption can be chosen to be either legacy, Strong or Strong rules .
    *Please read the Knowledge Base about user level permissions.
    *Please read the Knowledge Base about password encryption mode.
  3. This member when logins for the first time, will be directed to the page where they need to create a new password that is known only to them.

 

3. Meaning of signature (author & reviewer/approver) should be displayed during signature

LabCollector

ELN

LSM

  1. The signature with the complete user name along with the time stamp will be shown in the version option. 
  2. The superadmin, admin and the owner can sign the record.
  1. ELN allows to sign pages/sub-pages. Who closed the page along with their name & timestamp will be present on the page.
  2. Supervisors can create electronic signatures to sign off pages. 2 validators (one is eye witness) can sign ELN pages and their signatures will be visible along with the time stamp.
    *Please read the Knowledge Base ELN Signatures

  1. Only operators of the test and validators can sign the job. This information can be used in the report templates via dynamic tags.
    *Please read the Knowledge Base on dynamic tags for report template in LSM.
    *Please read the Knowledge Base LSM report generation.
    *Please read the Knowledge Base LSM digital signatures.
  2. Operators can sign off, to pass a job to COMPLETED status , whereas Validators can sign off to pass a job to FINISHED status.
    *You can choose to activate the compliancy in LSM and choose 2 step validation.

 

4. Electronic signature should show the signer’s full printed name, to show the time and date of execution

LabCollector

ELN

LSM

  1. The versioning list will show all the modifications and editions done on a record.
  2. These signatures with the full name along with the time stamp will be shown in the version option.
    *You need the compliancy pack for this part to be visible in your LabCollector.

 

  1. The ELN shows who signed pages, along with their full name & time stamp.
    *Please read the Knowledge Base ELN Signatures

  1. LSM allows to show the operator name, who did the test.
  2. The full name of the validator or validators (is 2 validators choose to sign), will be visible along with the time stamp.
    *This is possible with the use of the dynamic tags.
    *Please read the Knowledge Base on dynamic tags for report template in LSM.
    *Please read the Knowledge Base LSM report generation.
    *Please read the Knowledge Base LSM digital signatures.
  3. You can also check with the compliancy ON, about the changes done to the job, with the help of status tracking..

 

5. The signed record should be locked from editing and deletion.

LabCollector

ELN

LSM

  1. Once the record is signed it will become locked and more editions will not be possible on it.

  1. The page after the signature will become locked and you will see a lock sign in front of the page name.
  2. Only erratum can be added to a page after its locked. No other content can be changed anymore.

  1. In LSM once the job/test is approved it is not editable anymore. These jobs will have green color in options in front of them.
  2. The option to edit the job is no more active. (greyed out)
  3. You can only open a job and add a general comment to a finished/validated job.

 

 

6. Electronic records must be maintained and linked to signatures for the life of the electronic record

LabCollector

ELN

LSM

  1. The record once signed off cannot be deleted.
  2. The record once signed off will always contain the information about who signed it. See sections above for explanation.
  3. You cannot delete the signed jobs, but only archive them.
  1. The pages that are signed off will be locked off and will always show who closed the page and signed them.
  2. In ELN you cannot delete pages, so you will always have the record information of a person signing & closing a page.
    *Please read the Knowledge Base ELN Signatures
  3. You can archive books/projects but these will be only hidden and can be made visible easily and will contains signature information for the page lifetime.
  1. Once the job has been signed off (finished) the job cannot be deleted. It can only be archive. Even if you archive or unarchive it, you will always see who validated the job.
  2. You can generate a pdf report for the job/test until its lifetime that will always show who validated the job with timestamp. See section 1 above for explanation.

 

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