How to Make Your Lab CFR Part 11 Compliant

Ensuring your laboratory adheres to CFR Part 11 is crucial in the era of digital record-keeping. The FDA issued a regulation that sets standards for using electronic records and signatures in research and development. Here's a straightforward guide to understanding and achieving compliance with these FDA regulations.

Understanding CFR Part 11 Compliance

CFR Part 11 is a crucial regulatory requirement within the FDA's 21 CFR part. It guarantees that electronic records and signatures are just as reliable and trustworthy as their paper counterparts. Key requirements include:

• System Validation: Ensuring that computer systems perform consistently and reliably.
• Audit Trails: Maintaining detailed logs that show who accessed or changed electronic records and when. These logs are crucial as they provide a type of audit trail that ensures experiment compliance in R&D.
• Record Retention: Ensure you create, modify, maintain, archive, and retrieve records in compliance with FDA guidelines.

Example Use Case: A pharmaceutical company implements a Laboratory Information Management System (LIMS) to manage clinical trial data. They must check the LIMS to ensure data safety. The system should track all data entries. It must also store records for the required time as per FDA regulations.

The Problem of Handshakes Between Lab Teams

In labs, data and samples move through different teams such as the wet lab, dry lab, and quality control. This helps to keep track of where the data and samples are at all times.

Each team is responsible for a specific part of the process. This ensures that the data and samples are handled properly and accurately. Each transfer can risk the integrity of the data and samples, potentially breaking the chain of custody.

Example Use Case: A sample is created in a wet lab and then analyzed in a dry lab during drug development. Using a LIMS for documentation ensures that it securely records any custody changes, maintaining the sample's integrity.

Choosing the Right Digital Tools for CFR Part 11 compliance: SDMS, ELN, LIMS, and QMS

It is important to select digital tools that follow LIMS CFR Part 11 guidelines. This will help avoid problems with data and workflow integrity. Compliance with these regulations is crucial for maintaining the accuracy and security of information.

Choosing the right tools can prevent potential issues and ensure smooth operations. These tools include:

• SDMS (Scientific Data Management System): Manages and tracks documents and data securely.
• ELN (Electronic Lab Notebook): Serves as a digital version of lab notebooks for recording experiments.
• LIMS (Laboratory Information Management System): Manages samples and associated data while ensuring data security.
• QMS (Quality Management System): Ensures that you consistently produce and control products according to quality standards.

Example Use Case: A biotech startup uses an ELN LIMS CFR Part 11 compliant system to record experiment results. The system automatically timestamps and requires electronic signatures for entries, ensuring compliance with Part 11 requirements.

Scispot: A Modern Solution for CFR Part 11 Compliance

Scispot is a software platform that combines ELN, LIMS, QMS, and SDMS functionalities. It ensures CFR Part 11 compliance through integrated tools designed for modern laboratories.

• Integrated Digital Lab Notebook (Labspaces): Facilitates secure and compliant record-keeping with robust audit trails and data integrity features.
• Scientific Data Management (Labsheets) manages both structured and unstructured data, supports advanced data analysis, and ensures meeting internal controls.

Example Use Case: In a clinical research organization, scientists use Scispot’s Labspaces to document their research securely. Every entry is electronically signed and timestamped to ensure data integrity in compliance with the Sarbanes-Oxley Act. The Labsheets feature allows the team to securely analyze data and maintain a clear, auditable trail.

‍