Data integrity is a high profile issue in the Life Science industry globally, partly as a result of enforcements, overseas inspections and criminal prosecutions instigated by FDA, MHRA and other European regulatory authorities. It would be a media-fuelled availability error to jump to the conclusion, based on the highest profile cases, that data integrity is a problem largely centred on drug manufacturers in Asia. 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, high profile cases, such as those involving Sun Pharma, Wockhardt, GVK Biosciences and Aptuit have had the effect of raising the level of suspicion and reducing the level of trust in the industry, with regulators and the public concerned about the reliability of trials, internal oversight, and the products themselves.
This white paper will share insights on how to turn those negative nudges into positive nudges in the right direction by:
- Modernising your operational processes
- Strengthening internal controls
- Eliminating obsolete systems based on paper files, spreadsheets and email
- Addressing professional ignorance and managing competence in research staff
- Modelling and managing risk
By improving the management of the operational processes involved in clinical trials, drug manufacture, contract services such as testing and distribution and packaging you can dramatically improve the overall performance of your organisation, reduce the risk of non-compliance, prevent failures and damage, and protect your corporate, professional and even personal reputation.