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.

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
  • 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
  • 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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