X-ray analysis systems and services fully support compliance with the US FDA's regulation on electronic signatures in the pharmaceutical and related industries
The United States Food and Drug Administration (FDA) regulations 21 CFR part 11 governing the use of electronic records and electronic signatures have implications for the pharmaceutical and related industries and for their suppliers.
The regulations relate to processes in the pharmaceutical industry, but whereas initially only manufacturing processes were involved, the requirements now extend to development and even research processes.
Since Panalytical's X-ray analysis systems play important roles in supplying elemental (X-ray fluorescence) and micro-structural phase (X-ray diffraction) information about materials relevant to the industry's processes, these systems and their development and production should also support 21 CFR part 11 compliance.
Panalytical was the first supplier of X-ray analysis systems meeting the requirements with so-called hybrid signatures and services to support Installation Qualification (IQ) and Operational Qualification (OQ).
The company now plans to release systems with full electronic signatures and audit trailing later this year, together with extended services for Design Qualification (DQ) and support for Performance Qualification (PQ).
A white paper containing detailed information will be issued in the coming months.
Panalytical looks on this as part of its continuous drive to provide added-value solutions to its pharmaceutical customers through the supply of the most advanced X-ray analysis systems and services. For X-ray diffraction (XRD) analysis the systems comprise the Xpert Pro MPD or Cubix Pro diffractometers together with the Xpert Audit Trail (version 1.0), Xpert Data Collector (version 2.1) and Xpert HighScore Plus (version 2.1) software packages. For X-ray fluorescence (XRF) analysis the offering comprises a wavelength dispersive X-ray spectrometer and SuperQ software package with the enhanced data security option.
This combination is specifically targeted at the pharmaceutical market and related industries.
All these systems can easily be interfaced with the audit trailing part of Lims applications.
More detailed information will be released this summer.
