Freezerworks is written and tested in according to FDA regulations and guidance documents, including GMP Quality System Regulation (21 CFR Part 820), Electronic Records – Scope and Application (21 CFR Part 11), and General Principles of Software Validation (FDA Final Guidance for Industry). Click here for ore information.
Freezerworks and Freezerworks Unlimited have the following features that will ensure compliance when used properly:
- A login and password system that forces users to enter a name and valid password to continue.
- An audit trail that is read only and cannot be accessed, entered, or manipulated by any user. For every data entry field that is modified a record is created that stores the name of the user making the change, the field, the previous field entry, the new field entry, and the time and date the entry was changed. Any tampering of the data, accidental or deliberate, is monitored by the system’s automatic and fully secured audit trail, indicating who made a change and when.