Last week I answered the question: Is Fishbowl FDA compliant? It turns out that that question is framed incorrectly because no software can claim to be FDA compliant. It’s up to businesses to use Fishbowl’s technical control features in a way that meets FDA compliance standards.
So the question becomes: What are the technical controls Fishbowl offers to allow companies to become FDA compliant?
How Fishbowl Meets Part 11 Software Requirements
Here are 11 features Fishbowl offers to facilitate this process and fulfill Part 11 (specifically Section 11.10) software requirements:- A process of system validation to make sure it is consistent and reliable in its accuracy, and users are able to spot invalid or changed records.
- The ability to duplicate records so that there can be accurate physical and electronic copies.
- Adequate security surrounding records to ensure their accuracy and accessibility through the period of records retention.
- Restricting access to the system to specific individuals with the right clearance.
- The ability to set up authority checks to prevent unauthorized individuals from using the system, accessing the computer system input or output device, electronically signing records, updating records, or doing other operations.
- Restricting access to only those individuals with the proper education, training, and experience to competently develop, maintain, and/or use the electronic records and electronic signatures system.
- Audit trails that are secure, time stamped, and computer generated.
- The ability to enforce specific sequencing of steps and events through operational system checks.
- The ability to check the veracity of data input and operational instruction sources through device checks.
- The creation and adherence to policies put in writing that ensure individuals take responsibility for everything they do under their electronic signatures.
- The ability to establish and use necessary controls over systems documentation.