The culture of an organisation directly correlates with the validity and accuracy of the data that it generates. In the on data integrity (Data Integrity and Compliance with Drug cGMP: Questions and Answers Guidance for Industry (2018)) the following is stated ‘it is the role of management with executive responsibility to create a quality culture where employees understand that data integrity is an organisational core value and employees are encouraged to identify and promptly report data integrity issues’. An organisation with a poor or immature Quality Culture can often have poor or immature quality practices, whereby issues are not appropriately documented, investigated and remediated. These organisations inevitably encounter challenges in adhering to and often have poor regulatory inspection records with repeat observations and violations. Conversely, organisations with a strong Quality Culture perform well with the regulators. These organisations are not error-free but their quality culture promotes a ‘do the right thing’ ethos when errors and issues arise.This transparency and openness gives the regulators confidence that the organisations data integrity is assured.
At Odyssey VC and CompliantCloud.com we endeavour to promote a culture of Quality across all organisations and functions at all level of the organisation to assure the integrity of all of our data and to ensure the provision of quality services and products to our customers.