21 CFR Part 11 Compliance of X-Ray Diffraction Data

X-ray diffraction (XRD) is a widely used tool in the pharmaceutical industry at every stage of the drug manufacturing process—from drug discovery to detecting drug impurities during the quality assurance process.

Yet how can pharmaceutical companies use X-ray diffraction data in a way that complies with the U.S. Food and Drug Administration’s Title 21 CFR Part 11? This federal standard regulates how life sciences companies maintain the security of electronic records and electronic signatures in the digital age.

To help pharmaceutical companies meet these requirements, Thermo Fisher recently introduced Thermo Scientific SolstiX XRD Software with Security Suite, which enables pharmaceutical companies to comply with 21 CFR Part 11 using Thermo Scientific’s suite of ARL EQUINOX X-ray diffractometers. Designed to work with Thermo Scientific XRD software, the package provides maximum security and data integrity assurance while offering the flexibility required to meet the varying analytics needs of pharmaceutical labs.

SolstiX XRD Software with Security Suite includes an intuitive user interface that enables pharmaceutical companies to maximize productivity while achieving 21 CFR Part 11 compliance.

Using SolstiX XRD Software with Security Suite, lab researchers can achieve compliant workflows using the robust, easy-to-use ARL EQUINOX X-ray Diffractometer to reliably characterize the chemical and physical properties of active pharmaceutical ingredients. The security package enables laboratories to:

• Control user access: The software works with Windows security to authenticate users via one or multiple instruments.
• Easily store and retrieve data: Data is automatically saved and can be retrieved using Thermo Scientific OMNIC Software or with database or graphical programs.
• Establish responsibility with digital signatures: Cryptographic user authentication is used to establish responsibility for records and prevent tampering.
• Create thorough audit trails: Non-editable spectral histories stay with the data to provide comprehensive audit trails—with file events and program use logged for complete traceability.
• Quickly share records with auditors: Records can be previewed and printed in a human readable format for easy inspection and review by auditors.
• Maintain security without compromising productivity: An intuitive, customizable user interface enables pharmaceutical companies to maintain productivity while ensuring they follow established procedures.

Using SolstiX XRD Software with Security Suite together with the ARL EQUINOX XRD, pharmaceutical companies can confidently achieve 21 CFR Part 11 compliance while getting the high-performance results they need as they work to develop safe and effective pharmaceutical formulations.

To learn more, please see our SolstiX XRD Software with Security Suite webpage.

Raphael Yerly is Product Manager, XRD at Thermo Fisher Scientific.