Knowledge is vitally important in the pharmaceutical sector. From raw data from experiments to complex chemical formulae; from precisely executed drug trials to intellectual property rights – without this information the sector would be unable to perform. In case of loss or damage of this confidential information, an organisation puts itself and its customers at irrevocably at risk. Awareness and responsible management of information risks are vital for the healthy functioning of the pharmaceutical sector.
The pharmaceutical industry is therefore one of the most regulated sectors. The legislation and regulations of the FDA/EU 21 CFR Part 11 clearly set out the requirements in terms of reliability and authenticity of data created and stored electronically.
Ordina’s Quality and Validation consultants work from leading pharmaceutical companies and their suppliers. They have an in-depth knowledge of the regulations and legislation (cGxP, CFR21 Part 11, ISO 9001 or ISO 13485) and completed the Ordina Secure-by-Design programme (CISSP(ISC)2, CISA, CISM).
Our validation experts correctly assess your risk in terms of data integrity in the use of systems that store, process or retrieve data (mobile applications, cloud solutions or web applications) during every validation assignment.