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Pharma Deviation Report

Regulated process of handling manufacturing irregularities for the pharmaceuticals industry

Multi-stage process of filling out manufacturing deviation report in the pharmaceuticals industry. Includes stages of discovery, investigation and corrective and preventive actions (CAPA), handled by multiple responsible parties. All of the information can be entered and tracked from a single location, making it just so much more convenient!

The process is made up of 5 stages:

  1. Initial Entry - the deviation is discovered and reported. Any authorized user can submit the report.
  2. Production Manager - investigation, including collection of professional opinions, and recommendations for further handling. Users in Production Managers site group are allowed to enter information at this stage.
  3. Head Pharmacist - analysis of influence on product quality. Users in Head Pharmacists site group are allowed to enter information at this stage.
  4. QA Manager - generation of corrective and preventive actions. Users in QA Managers site group are allowed to enter information at this stage.
  5. Closure - completion of actions and closing the report. The report cannot be closed while there are still unfinished actions. Users in QA Managers site group are allowed to enter information at this stage.

You can enhance the system even further by adding alerts (using Smart Alert Pro) and print-out (using Smart Print Pro).

Upon site creation you need to add your users to the site groups. Once the site groups are populated, you can start using the process. Feel free to modify the site in any way you deem fit, adding or removing columns, adding or modifying list views or changing the homepage layout.

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Sample business solutions

IT/Engineering

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