Data integrity is crucial for pharmaceutical companies and other strongly regulated industries like life sciences, biotechnology and food.
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.
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.