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. The installed products will function fully for 30 days, after which you need to purchase licenses to continue using the site.

All templates require US English language pack to be installed on the farm.
Our templates can be installed on SharePoint Foundation 4.0/5.0 or SharePoint Server 2010/2013/2016.

This business process is available for download as a self-installing, self-configuring site template for SharePoint Foundation 4.0/5.0 (SharePoint 2010-2016). The template itself is free to use, but it is based on our commercial product - UltimateForms. Trial versions of the necessary components are installed automatically by the template. Once purchased, the product can be used to improve all sites, based on our templates or the ones you create yourself.