In regulated manufacturing, data integrity is essential. The FDA’s 21 CFR Part 11 defines how electronic records and signatures must be managed to ensure that all digital information is secure, traceable, and tamper-proof.
In powder processing, this regulation applies to batch records, quality control data, and equipment logs — proving that every action is recorded, verified, and auditable.
Non-compliance can lead to rejected data, regulatory action, or production delays.
To comply, systems must provide:
– Secure, role-based user access
– Full audit trails of who did what and when
– Verified electronic signatures
– Protection against data loss or tampering
