FDA 21CFR PART 11 REGULATION

JANUS® G3 Workstations

Need a Hand with FDA 21CFR Part 11 Regulations? PerkinElmer Can Help.

21CFR Part 11 Compatible WinPREP® Software—Available with JANUS® G3 workstations!

PerkinElmer Applied Genomics is firmly committed to meeting your needs in the demanding, ever-changing pharmaceutical and biotechnology industries. To assist in your compliance planning, we offer the Enhanced Security Option for JANUS® G3 workstations which includes access security, data security and verification, and a complete set of audit logging functionality.

  • Instrument Access Security

    • Instrument access limited to authorized users only. User name, plus password identify each user in the software.
    • Passwords are fully configurable with syntax requirements and expiration dates.
    • Configurable timeout for system inactivity requiring the user to re-enter their user ID and password.
  • Data Security & Verification

    • Data automatically secured from the instant it is generated.
    • Files pertinent to a specific protocol run are bundled at the end of the protocol to provide a unique “fingerprint” of the protocol run.
    • Verification confirms that bundled files have not been tampered with.
  • Audit Logs

    • Full auditing facilities so instrument settings, protocol runs, and parameter changes can be validated.
    • Logon events, methods, report formats, and evaluation parameter changes are tracked.
    • Bundled files provide an audit trail and allow for easy access to protocol information during an audit.

As the trusted partner of researchers worldwide, PerkinElmer understands that you require faster and easier solutions to comply with the FDA’s regulations. The Enhanced Security Option for JANUS® G3 workstations maintain the use of a flexible, user-friendly WinPREP® software environment. Now that’s a fast and easy solution!

JANUS® G3 WORKSTATIONS

JANUS G3 Workstations

The JANUS® G3 automated liquid handling workstations offer flexible automated sample preparation solutions to meet your specific application needs. The 21CFR Part 11 compatible WinPREP® software works seamlessly with the JANUS® G3 workstations providing you the tools that enable you to be Part 11 compliant.

JANUS G3 Workstations

Please contact your local PerkinElmer representative for more information.

For research use only. Not for use in diagnostic procedures.