Insights

How Does Quality Culture impact data integrity?

By Nicola Brady

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.

The GDPR & cGxPs – What do we do??

We recently attended a seminar in Brussels to examine the impact of the EU’s General Data Protection Regulation (GDPR) on the operation of R&D and science and on collaborative research in the EU and with its global partners. Our interest is in the cross-over between the GDPR and the regulations that govern our clients businesses such as the CFR’s, PIC/S and Eudralex to name a few. The GDPR entered into force on 24 May 2016 and will apply from 25 May 2018. The regulation is aimed at empowering the citizens as owners of personal data, as well as establishing legal certainty for business based on clear and uniform rules.

The GDPR will apply to all organizations in and outside the EU that deal with the personal data of EU individuals. Science-based and research organizations will need to take advantage of the two-year transition period up to 25 May 2018 to prepare for a significant increase in their data protection responsibilities and advance their privacy compliance programmes.