Pharmaceuticals | Sermon Business Solutions

Pharmaceuticals

We summarize how we can improve pharmaceutical industry companies with the following points :

  • It adheres to the stringent data validation, security and process integrity requirements mandated by the FDA 21 CFR Part 11 (which specifies additional controls for electronic records and electronic signatures).
  • It seeks to improve business practices and the benefits may include:
  • Lowered cost of data collection
  • Increased accuracy of data
  • Increased data analysis capabilities
  • Reduction of regulatory errors (for example: misfiling)
  • Improved information transfer between departments (for example: operations and quality)
  • Improved information transfer between companies (for example; external research organization and the sponsoring enterprise)
  • Improved product recall The FDA is permitting manufacturers to benefit from emerging technologies, to streamline record keeping and compliance Microsoft Dynamics for life sciences companies requiring FDA and GMP compliance, supporting a range of compliance strategies.
  • As appropriate to the mid-sized company, dynamics supports the people rather than forcing them to support the system. The solution allows companies -who must adhere- to the stringent data validation, security and process integrity requirements mandated by the FDA to leverage the power of Microsoft’s integrated business systems.
  • It provides audit trail tracking and reporting in all areas of the ERP system that are FDA significant, including records, inventory status transactions, process instructions and recording of results. And it provides organizations that manufacture medical devices; drawings can be attached to items so everyone has easy access to technical specifications.

AMMAN

RIYADH

JEDDAH

KHOBAR

TRIPOLI

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