Advanced process digitization, often denoted as Industry 4.0, is revolutionizing the pharmaceutical industry. Today, all key players are allocating substantial resources to the evaluation, implementation and validation of various hardware and software solutions to support this digital transformation.
Regulatory agencies are gradually preparing for this paradigm shift and increase their attention on data governance, data integrity and data lifecycle management.
Most probably, you already apply ALCOA+ principles as a guideline to compile complete, consistent and accurate data. But are you fully aware of all the integrity gaps and breaches that exist in your organization? Needless to say, data integrity is essential to guarantee product quality and patients’ safety, but in order to fulfill all data integrity requirements in an evolving digital ecosystem, merely following ALCOA+ is grossly insufficient.
In order to address the growing need of the industry to implement data integrity in a smart and efficient way, Pauwels Consulting has developed a unique data governance program. The program combines a thorough pre-assessment with subsequent transition according to the well-known PDCA cycle. GAP assessments and associated actions are carried out in parallel across each department with continuous feedback loops and include alignment of all DI-related documentation (e.g. URS, data handling procedures, etc…).
Our risk-based and pragmatic approach embeds strong leadership and proper behavioral management. It is designed to achieve and sustain DI cultural excellence across the entire organization. Proper training is crucial so our Data Integrity team has compiled a variety of training modules that can be tailored to achieve these goals, together!