How LIMS Ensures FDA 21 CFR Part 11 Compliance

21 CFR Part 11 describes the Food and Drug Administration's (FDA’s) regulations for electronic records, and electronic signatures. 21 CFR Part 11 is designed to ensure that electronic records can be relied upon in the same way that paper and handwritten documentation, and associated signatures, have been. It has been widely implemented where electronic systems are in place and failure to comply can lead to FDA citations and issuing of warning letters.

The use of paper and ink documents such as laboratory notebooks for storing instrument readings, intermediate calculations and final test results has the advantage that changes can be easily seen by the required crossings out and replacement of text. Manual signatures, such as on a certificate of analysis can also be used as final laboratory approval. 21 CFR Part 11 provides solid guidance to reproduce the same level of security in electronic records to prevent mistakes or fraud.

21 CFR Part 11 recommends certain controls and requirements including:

• Secure storage of data (and documents/records), limiting system access to authorized individuals
• Use of version control to detect altered data
• Ensuring individuals are properly trained to perform their assigned tasks
• Only authorized individuals may alter or approve data and electronically sign documents
• Establish and follow policies for actions and procedures
• The use of electronic signatures

Clearly these are sophisticated requirements, and this is one of the reasons why trying to achieve 21 CFR Part 11 compliance using spreadsheets is difficult, if not impossible.

Data Security

Autoscribe solutions keep data secure within a database. The database itself may be encrypted. Access to data is password controlled with screens that can lock automatically after defined periods of inactivity. Test results may only be entered by properly trained technicians, and a record of who entered data and when is kept. Changes to all records are recorded together with details of who made the changes, when they were made and, if required, a reason for the change. This means that a full audit trail along with a history of all previous values of the records is kept.

Electronic Signatures

Part 11 mandates that electronic signatures shall be traceable to the individual, and include specific items including name, date, and reason for the signature (i.e., the final approval of a specific certificate of analysis be a responsible person). Electronic Signatures are built into Autoscribe’s Xybion LIMS solution and for items such as certificates of analysis provide full version control.

Using LIMS to Drive 21 CFR Part 11 Compliance

Autoscribe’s Xybion LIMS provides a solid foundation to automate the storage and management of laboratory data. It is used to manage the laboratory workload, manage sample data, store results, and generate reports, and is the complete solution to your LIMS needs.

Xybion builds in the controls and checks laboratories need to be compliant with FDA 21 CFR Part 11. Organizations embracing the access security and electronic signature policies built into Xybion LIMS, and train their staff to use them consistently, will be driving best practice for electronic documentation.