Reliable Data

Reliable Data

High quality regulatory data

Any IT solution for capturing data is only as good as the data which are fed into the system. Unreliable data leads to double-checking, which is capacity and cost intensive.

Giving the staff feeding the IT-systems clear and feasible workflows for data entry provides reliable IT evaluation.

My services include:

  • Development of workflows for capturing reliable regulatory data within IT applications
  • Preparation of quality control
  • Assistance with training and implementation by consulting, coaching and quality control

Regulatory data for the GMP environment

Annual filing of regulatory data for the Product Quality Review (PQR) has been a requirement since January 2006. Product Supply releases products only in accordance with the approval system in the respective country, so the required data are available within the company. Nevertheless, the data are scattered within the company and are of differing quality and therefore incompatible for IT solutions. A lot of effort is required – costing time and resources – to consolidate the data accordingly.

Clear workflows and an appropriately designed environment for capturing and controlling regulatory data save time, capacity and costs.

My services include:

  • Development of workflows for capturing regulatory data
  • Supporting management in adapting the flow of regulatory data so that it meets the requirements of both GMP and Product Supply
  • Assistance in implementation by consulting, coaching and quality control