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Software validation and Lifecycle Management for SAS Software

Nothing is more invariable than change, and hence the majority of the work in a software system flows into the maintenance and adaptation. Changes are always a challenge for the quality. Those who plan changes and the required quality assurance right from the outset, save time, money and nerves.  

In addition to this, companies in different industries are legally obliged to verify and prove the quality of all conclusions resulting from any data, so as to avoid risks, for example, to the health of individuals or the national economy. This applies in particular to the following sectors:

  • Companies that manufacture medical products have obligations imposed on them by regulatory authorities to validate their programs and data.
  • Businesses in the financial industry obtain the minimum requirements for risk management (MaRisk) from the Federal Financial Supervisory Authority (BaFin), to which operational risks, and therefore IT systems, also belong.

We advise and implement measures, so that your SAS software can also function in a rapidly changing environment, and also help in complying with the regulatory requirements in quality and documentation of the software:

  • Writing of validation plans and SOPs
  • Performance of risik analysis
  • Conducting and documenting tests, also automatically with our unit testing tool SASUnit
  • Setup of technical environments for Lifecycle Management (development, test, production) on the basis of the SAS Metadata server
  • Analysis, evaluation and implementation of modifications to existing systems or programs.

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