What is 21 CFR Part 11?
21 CFR Part 11 refers to the US FDA (Food & Drug Administration) guidelines for trustworthy electronic records, which requires companies to employ procedures and controls designed to ensure the authenticity, integrity and, when appropriate, the confidentiality of electronic records.
It is fully known as
Title 21 Code of Federal Regulations (21 CFR Part 11)
Electronic Records; Electronic Signatures.
This particular level of compliance is prevalent in the food and pharmaceutical industries.
What compliance issues does it present?
From documented processes to electronic signatures, the guidelines for 21 CFR Pt 11 were laid down to provide a framework to ensure companies build their electronic systems in a compliant manner. Like many standards, it allows a certain flexibility in how your systems operate in order to comply as opposed to a step-by-step list of absolutes. This allows you to enhance or tighten existing systems in order to provide the level of compliance necessary without the need for a complete start from scratch.
Any records held in electronic form must be controlled and that signatures must be reliable and
an equivalent to paper records.
How can IdeaGen's software solutions help us?
Our software is configurable to allow electronic signatures to be necessary at every significant stage of approval and action.
Moreover, it is completely traceable thanks to the systems' exceptional history and audit trails that record who did what and when at every key stage.
Information is stored in our secure database structure ensuring complete control over access to that information. The key to this approach over systems where the information is stored as files on a server is that even the I.T. system administrator does not have access to your sensitive information without a specific system login granted by you.
The system can force you to view changes to documentation and require an electronic approval and acknowledgement. This can also be driven via your email system for ease and accessibility.
IdeaGen has many existing customers in the Food and Pharmaceutical industries using our software solutions Quality Workbench and Workbench Professional
Speak to our sales team to find out how we could help you.
FDA/ 21 CFR Part 11
