Compliance with regulatory standards is, of course, key to the success of any IT system used within the pharmaceutical industry.

Tessella has experience of developing solutions for use in a number of regulated environments, such as FDA (Food and Drug Administration), GxP (various industry Good Practice guidelines), Nuclear and the Rail Industry. Central to our ability to develop systems that satisfy the scrutiny of auditors are the high academic standards of our staff, and a very powerful quality management system.

Tessella has held TickIT accredited certification to BS EN ISO 9001 (formally BS5750) since 1992. Since then we have continually evolved and improved our quality system to allow us to deliver top class software systems to demanding clients in scientific and engineering organizations. Our processes are audited every 6 months by the BSI, and are often inspected by our clients.

Our experience includes:

• Validation and Verification of 3rd party applications in preparation for FDA 510(k) pre-market submissions.
• Development of applications compliant with FDA Rule 21CFR Part 11, (giving the regulatory framework required for submission of electronic records in lieu of traditional paper submissions).
• Technologies used to implement Process Analytical Technology, including data processing, multivariate modelling and analysis, data storage, and automated systems control.
• European CE marking for medical devices