5/1/2018 What is FDA 21 CFR Part 11?

| Eurotherm Life Sciences

Understanding 21 CFR Part 11

Issued by the FDA (Food & Drug Administration) in 1997, the 21 CFR Part 11 final rule is intended to permit the widest possible use of
electronic technology. This is divided into two main sections:

Electronic Records
Electronic Signatures

These are a natural extension to the traditional use of paper records. Paper records provide data security and can carry handwritten
signatures to indicate that certain data is correct and log events, which took place. Attempted corruption of either the data or signatures is
readily detectable.

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In basic terms the requirement of Electronic Records is to provide secure data which can provide a high level of confidence as would be the
case with paper records. Electronic signatures require that both operators and supervisors can electronically identify themselves in such a
way as to be equivalent to handwritten signatures. The rule also permits the use of biometrics such as fingerprint or retinal scan devices.

The advance in electronic systems offers significant benefits for data retrieval and storage of data. The FDA developed the 21 CFR Part 11
rule to describe what they require to be comfortable that the electronic records and signatures are secure.

21 CFR Part 11 Made Easy!

From plant wide data access security management to single, secure recorders - let us help you choose a solution that is right for you.

Solutions designed for ease of validation

Minimize validation time and testing by using standard, built-in features to meet the FDA's 21 CFR Part 11
Data recording at every level, local and plant wide
Never lose your data with cost-effective, multiple recording and secure back-up
Centralised security system provides maintenance of user accounts and passwords from one or multiple locations
Secure local data collection with automatic archiving across your network - truly designed to keep your data safe
Remediation solutions for legacy systems - "Wrap & Comply"

Electronic Records
Secure process values and audit trails (alarms, events, operator actions, log-in/log-out, operator notes, electronic signatures)
Protection of data through binary, compressed and check-summed records
Accurate time stamps are ensured using automatic Time Synchronization to a known clock source
Provision for electronically copying data for archive
Export facility providing viewing of secure records in human readable form

Electronic Signatures
All user actions can be configured to require signing or require signing and authorization
User specific access according to authority level
Signature element controls unique user signature, password expiry, minimum password length, automatic log-off, automatic disabling and
notification of failed login attempts
Ensuring unique users by retiring and not deleting accounts

Central Security Manager with full audit trail

Security Manager offers significant operation cost savings and ease of use allowing maintenance of user accounts and passwords from one
or multiple locations. If a user needs to change their password they can do so on a local instrument or PC and this will be automatically
distributed across all systems to which they have access.

A common security tool across multiple product ranges

Ch i l d l t
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5/1/2018 What is FDA 21 CFR Part 11? | Eurotherm Life Sciences
Change in one place, deploy to many
Support for multiple security zones
Built-in audit trail for 21 CFR Part 11 validation
Automatic version control
Support for electronic signatures

Additional Information
The Pharmaceutical Project Life Cycle
EurothermSuiteTM Operations Server/Viewer and 21 CFR Part 11
Visual Supervisor and 21 CFR Part 11

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6000 Series Recorders and 21 CFR Part 11
FDA Guidance for Industry Part 11, Electronic Records; Electronic Signatures - Scope and Application
Electronic Code of Federal Regulations (e-CFR): Title 21: Food and Drugs PART 11 - ELECTRONIC RECORDS; ELECTRONIC
SIGNATURES
www.fda.gov

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