21 CFR Part 11
Manage and Control Electronic Records for FDA Regulated Products
Do you produce an FDA regulated product? Do you use computerized systems to generate batch records? Do you submit data to the FDA in electronic formats? If so, you may have to comply with federal regulation 21CFR Part 11.
21 CFR Part 11 applies to electronic records and electronic signatures when an entity relies on the digital form of the data in lieu of the paper equivalent. There are a few categories of data that are considered within the scope of this code of regulation:
- Records required by the FDA to be maintained under the predicate rule
- Records submitted to the FDA under the predicate rules
- Electronic signatures serving to be an equal substitution to handwritten signatures
The key to the inclusion of all the above categories into the control system is that the electronic form of record or signature is the form relied on in lieu of the paper equivalent.
Data Encryption and Storage
Cycle Assist enables the operator to automatically generate Freeze Drying Protocols, including Annealing and Supercooling steps.
Audit Trails
A batch report can be printed in PDF format that includes the operator name, protocol, data measurements over time, graphic data, alarms, and a log of any adjustments made to the cycle.
Electronic Signatures
The freeze drying protocol is entered step by step. Where a step requires an electronic signature, the change is logged. The protocol or recipe is stored and available for use.
User Password Levels
Simply choose your shelf temperature ramping method, either by time or rate and Opti-Dry Gen2 does the rest.