WinLims for the pharmaceutical industry

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Courtesy of Quality Systems International (QSI)

The production of pharmaceuticals is highly regulated by the FDA, MCA, and other regulatory organisations around the world. Auditing of pharmaceutical companies is carried out on a regular basis to ensure that all areas of the business are adhering to the approved quality procedures. The laboratories and any LIMS in use are subjected to this scrutiny.

Hence it is crucial for WinLIMS to provide the tools to meet both the regulatory bodies strict controls and the functionality required by the laboratories.

The regulatory adherence tools include:

  • Electronic Signatures (21 CFR Part 11)
  • Extensive Audit Trails
  • High Levels of Security
  • Version Control

The laboratory functionality included comprises.

  • Stability Trials
  • Complaints & Corrective Actions
  • Formulations
  • And more …..

These capabilities, in conjunction with the WinLIMS core functionality, provide a unique solution for the pharmaceutical laboratories without the need for extensive custom code. The benefit of this approach is to reduce cost without sacrificing industry requirements or performance.

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