Regulated laboratories need to ensure electronic records and electronic signatures can be relied upon in the same way as paper records and handwritten signatures. Using a LIMS helps enforce signature policies to meet FDA 21 CFR Part 11.
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 the 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
Instem 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 the data and when it 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 by a responsible person). Electronic Signatures are built into Instem’s Matrix Gemini LIMS solution and, for items such as certificates of analysis, provide full version control.
Using LIMS to Drive 21 CFR Part 11 Compliance
Instem’s Matrix Gemini 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 it is the complete solution to your LIMS needs.
Instem builds in the controls and checks that laboratories need to be compliant with FDA 21 CFR Part 11. Organizations embracing the access security and electronic signature policies built into Matrix Gemini LIMS and training their staff to use them consistently will be driving best practice for electronic documentation.
Ensure full compliance with FDA 21 CFR Part 11 regulations. Learn how Matrix Gemini LIMS enhances data integrity, enforces secure electronic signatures, and streamline compliance processes. Contact us today to learn more.
