"Good science is based on reliable observation and the data can only be relied upon if scientists are open and honest. People in the UK generally trust science because they know that experimentation is the most reliable route to knowledge. Anything that could be seen to jeopardise both the process and the trust it engenders is dangerous and needs to be rooted out."
— Sir Paul Nurse, President of the Royal Society
Data integrity is a high profile issue in the Life Sciences industry globally, partly as a result of enforcements, overseas inspections and criminal prosecutions instigated by FDA, MHRA and other European regulatory authorities.
Data integrity issues affect pharmaceutical companies everywhere. The majority of cases are caused by inefficient and fragmented business processes rather than deliberate fraud, most are captured by internal inspection and audit processes within the business and, therefore, remain buried and never come to light. However, to protect themselves from exposure to the risk of non-compliance with data integrity norms and laws such as the Food and Drug Administration Safety and Innovation Act (FDASIA), Drug Quality and Security Act (DQSA) and EU GMP, organisations must implement a risk based quality management system that drives constant improvement in product and process reliability. Helping them;
- Modernise operational processes
- Improve the overall performance of your organisation
- Reduce the risk of non-compliance
- Prevent failures and damage
- Protect your corporate, professional and personal reputation.
Check out our 'White Paper, A Nudge in the Right Direction', which discusses a systematic approach to compliance management in the laboratory.
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