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FDA

FDA

Product catalog summary

Introduction
This white paper from ESA Automation discusses the importance of the FDA's 21 CFR Part 11 regulation, which governs the use of electronic records and signatures in the production processes of companies operating in or exporting to the United States.

FDA and 21 CFR Part 11 Overview
The FDA (Food and Drug Administration) is responsible for regulating production processes in the food, pharmaceutical, and chemical sectors. The 21 CFR Part 11, established in 1997, ensures the safe and broad use of technology in industrial processes by setting standards for electronic records and signatures.

Key Requirements of 21 CFR Part 11

Standardized reporting systems for generating accurate electronic records.
Traceability of operations with historical consultation capabilities.
Centralized account management with secure login protocols.
Automatic role separation for different user types (e.g., administrator, operator).

Compliance Points

Regular password changes and secure access to system configurations.
Activity tracking with time and date stamps for all system interactions.
Automatic data saving and restricted access to unauthorized users.
Audit trails for all critical hardware errors and user activities.

Electronic Signatures

Electronic signatures must be linked to their respective records to prevent falsification.
Signatures should include the signer's name, date, time, and purpose.
Audit trails for electronic signatures must be maintained for at least five years.

Data Management and Security

Automatic data backup to central servers.
Unauthorized login attempts must be recorded.
Data must be human-readable and suitable for inspection.

Conclusion
Compliance with 21 CFR Part 11 is crucial for companies in regulated industries to ensure data integrity, security, and traceability. ESA Automation emphasizes the importance of adhering to these standards to facilitate safe and efficient production processes.

Catalog excerpts

WHITE PAPER The Heart of Automation and the Art of Innovation WHITE PAPER

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What is the FDA? In other words, it makes sure that all requirements rules and standard are met in these areas. The FDA (Food and Drug Administration) is the American agency responsible or the control and regulation of production processes in the food, pharmaceutical and chemical sectors. Why is the 21 CFR Part 11 so important? The aim of the 21 CFR Part 11 is to allow the broadest and safest usage of technology in the industrial field. In order for this to be possible, it is necessary to verify that all the procedures of the production process comply with certain requirements. To be under...

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What are the most important requirements of the FDA 21 CFR Part 11? The 21 CFR Part 11 sets four fundamental points to be observed. • The need to have a centralized system for managing accounts, including the obligation of access through login with a username and a password. •Automatic separation of roles (administrator, technical analyst, operator, etc.). • The presence of a standardized reporting system in order to generate accurate and complete copies of records that can be read electronically. •The traceability of each individual operation, which must be part of a historic consultation at...

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Compliance points Yes (V) / No (*) Instrument/Equipment and Software shall have facility to : 1. Password policy

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ESA energy S.r.l. Via Fortunato Zeni 8 38068 Rovereto (TN) - Italia Tel. +39 0464 443272 Fax. +39 0464 443273 ESA elettronica S.p.A. Via Padre Masciadri 4/a 22066 Mariano Comense (CO) -Italia ESA elettronica S.p.A. Unita locale di Bentivoglio Via Monari Sarde 3 40010 Bentivoglio (BO) Italy Tel. +39-051-6640464 Fax +39-051-6640784 ESA elettronica S.p.A. Unita locale di Pontedera Via Molise,1 - Z.I. Gello 56025 Pontedera (PI) - ITALY Tel. +39 0587 296014 Fax. +39 0587 294240 ESA Europa S.L.U. Passeig del Ferrocarril, 335 08860 Castelldefels (Barcelona) - Espana Tel. +34 936455014 Fax. +34 936455013...

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