eLab Help Center

Visit the eLab Help Center for information about eLab including troubleshooting steps, solutions to common issues, and step-by-step guides.


Introduction to LIMS

What is and why your laboratory should use a LIMS system.


21 CFR Part 11

Introduction to the FDA and 21 CFR Part 11.


Guidance for Industry

A document containing FDA guidance on electronic records and signatures.

eLab Security and Compliance


Security

Today's laboratories are increasingly exposed to internal and external security threats. In response we have undertaken considerable effort to protect your data. From early in the planning phase we concentrated on ensuring the confidentiality and integrity of data maintained by the system. Advanced code analysis and source control tools were employed during development to enforce the highest levels of code quality. The result is a product built from the ground up to be secure.

A number of features help provide high levels of security for your data:

• A multi-tiered approach to data access implementing several separate layers of security.
• Fine-grained access control determines whether data is available to individuals, teams or roles.
• The installation wizard reduces the surface area of attacks by ensuring that only the features you need are installed.
• Enforced policies for logons, passwords and timeouts.
• Hashing of sensitive data to detect attempts to manipulate records.
• Comprehensive logging allows eLab to record all attempts to view, edit and insert data.
• Lock down of data ensuring that information can only be manipulated through the user interface.
• Each eLab installation runs from a secure per-user, per-application cache making eLab inherently isolated and contained.

Compliance

A key motivation underlying the creation of eLab was a reduction in the regulatory compliance burden that is increasingly being placed on laboratories. eLab implements a numbers of features that assist labs achieve and maintain compliance:

• Comprehensive data retention mechanisms.
• Detailed logging and traceability.
• Procedural versioning.
• Document management tools.
• The ability to integrate Standard Operating Procedures into workflows.
• Timely visual identification of sample and procedural issues.

Particular attention has been given to implementing a strict interpretation of the FDA's 21 CFR Part 11 regulation whilst future-proofing installations against changes in guidelines or levels of enforcement.