EE-LIMS facilitates regulatory compliance to the following standards
- 21 CFR Part 11
Section 11 of the 21 CFR sets forth the criteria under which the FDA considers electronic records and signatures equivalent to paper records and handwritten signatures. Our workflows and quality management business rules have us a step ahead of the pack when it comes to helping you realize compliance with 21 CFR Part 11.
Our team has developed a “7 step approach to reaching CFR 21 Part 11 Compliance” methodology that will get you to compliance:
1. Validation – Algorithms and business rules to validate/invalidate records based on accuracy, reliability and consistency.
2. Electronic Record Management – Standard feature to generate printed documentation of all records of all data in they system ready for auditing by an auditing power at any time.
3. Security and Qualification – Protection of the entire system to ensure that access is granted only to authorized and qualified individuals.
4. Record Retention – Retention of electronic records for a specified retention period of time as regulated by authorities.
5. Audit Trail – Un-editable time-stamped audit trails that record user activity.
6. System Documentation – Standard Operating Procedures (SOP’s) easily available to all system users at any point in a workflow.
7. EE-Signature – Authentication component that requires a multi-layer user identification component that includes unique user credentials with mandatory periodic resets, as well as use of a Personal Identification Number (PIN) at various stages of a workflow.
- HIPPAA
- Physical security : Information in EE-LIMS can be encrypted so that even if the hardware is stolen, it is not possible to access the data.
- User Security : user credentials are one-way encrypted and with proper password policies, it is extremely difficult to log on to the system by unauthorized personal and access the data.
- System Security : With proper server raid configuration and regular backups, it is possible to completely eliminate the risk of hardware crash.
- Network Security : As explained earlier (paragraph (b)), it is not possible for an external unauthorized personal to access the data within EE-LIMS system.