Data is omnipresent and of vital importance in regulated industries. Constant growth of data, combined with highly evolving technical environments, induces data integrity risks that can affect patient safety and product quality. Over the past years, governmental agencies have increased their focus on data integrity issues. Recent warning letters and non-compliance reports demonstrate the need for a dedicated company data integrity programme.
What can you expect during this training?
You will be introduced to data integrity
You will find out how data flows and paper-based as well as computerised systems are affected.
You will be familiarised with current regulatory guidance and good practices
You will be prepared to create a company-wide data integrity strategy
You will be able to execute data integrity gap assessments and implement remediation programmes.
This training is intended for anyone involved in data integrity for the pharmaceutical sector, the cosmetics industry, the food industry or related sectors.
Regulatory agencies and companies need accurate and reliable data to ensure the safety, efficacy and quality of products. This is especially important for medicines because the safety and health of patients must be guaranteed.
Data integrity is also crucial for guaranteeing trust between the industry and regulatory agencies. In the event of data integrity problems, regulatory agencies cannot ensure the quality of products. Moreover, regulatory agencies cannot constantly audit companies to inspect every part of the production process. Agencies must be able to trust an organisation to do the right thing and to guarantee the quality of products and processes. In short, data must be complete, consistent and accurate.
Data integrity in your company?
Quality by Design can assist you in identifying critical records, mapping the records lifecycle and flow, and assessing technical and procedural data integrity gaps. We can define an overall approach that leads to data integrity compliance. Thanks to years of experience and internal and external training, our consultants possess the required combination of knowledge about computer systems, business process flows and legislation related to data integrity. Together, we implement our standard methodology and adjust it to your specific branch, business and products.