Laboratory Concepts: Regulatory Compliance

 

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Fundamental Concepts

 
              

 

Fundamental Concepts

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The LabVantage LIMS (LV LIMS) platform complies with the requirements outlined in title 21, Chapter 1, Subchapter A, Part 11 of the Code of Federal Regulations (21 CFR Part 11) for electronic systems using Electronic Records and Electronic Signatures (ERES) for purposes of conducting business with the United States Food and Drug Administration (US FDA). The following are the features supported by LV LIMS out of the box:

• Maintenance of audit trail.
• Use of electronic signature (uniqueness, signature/record linking, components and controls).
• Maintenance of system access and data security.

Based on the above supported features, the regulatory agencies may consider the electronic records, electronic signatures, and handwritten signatures to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures. The platform also provides a framework for supporting automated Chain of Custody (CoC) and GxP needs within a laboratory.

Laboratory Concepts LabVantage Concepts Example
Audit Trail Auditing is a process of recording changes made to entities such as Samples, Products, Batches, etc. Enabling Auditing for an entity will create a duplicate set of data in an Audit table, tracking date, time and user making a change. A TraceLog table records the activity performed, date/time, the reason for change, and whether or not an electronic signature was required. The system also supports viewing of audit records. Several Users have edited Samples and entered data against them. Since Samples are audited, the LIMS has recorded all changes made to the Samples by each User (as described at the left).

I must determine information regarding the modification of 10 Samples. I select the Samples, then open the Audit page, which shows details of all Sample activity (as described at the left).

Electronic Signature Electronic Signatures (eSig) complies with the 21 CFR Part 11 requirements. Specifically, the following requirements are addressed:
•Signed electronic records contain the printed name of the signer, the date and time when the signature was executed, and the meaning (such as review, approval, responsibility, or authorship) associated with the signature.
•ESig employs at least two distinct identification components such as an identification code and password.
Chain of Custody Chain of custody (CoC) supports the chronological documentation, showing the custody, seizure, control, transfer, analysis, and disposition of physical/electronic sample or evidence. It helps in maintaining a complete audit trail for every specimen from collection to disposal or storage.

Within LabVantage, it establishes custody/ownership of a Sample. COC can be initiated either automatically (by configuration) or manually (though the UI). During manual transfer, a Custodian/owner must enter a password prior to accepting or relinquishing custody of a Sample. When relinquishing custody, you must identify both yourself and the Custodian to whom you are transferring the Sample.



Jim is the Custodian of a Sample. Jim manually transfers custody to Mary using the UI to provide Mary's username and password. Mary then becomes the Custodian of the Sample.
System Access & Security Upon log-in, a connection identifier is automatically assigned by the system. Validation of logon passwords is configurable using security rules that comply with defined security criteria. Each time I log onto the LIMS using my password, a unique randomly-generated identifier is used to establish connection to the LIMS data.

My password is validated and managed using security rules that have been customized to comply with my company's security criteria.

Web and session security is customized to fit the level of security required by my company.