A topic that is currently present in any organization leader´s agenda is the hype associated with innovation in digitization and data sciences.
While there is a strong desire to actively participate in this so-called Digital Revolution, some aspects are also subject of concern specially when we speak about data integrity and cyber security, just to name a few.
When we take GMP into perspective, those aspects and many others should be safeguarded as outlined by regulations such as the CFR Part 11, Computer System Validation requirements, and GAMP 5 guideline for instance.
Any new digital solutions should be qualified and the implementation properly validated. The higher the complexity of the digital solution the more extensive are the test plans to ensure no bad surprises occur after go-live activities.
Qualification and Validation efforts should be supported by an effective Risk Management strategy, allowing to foresee any potential failure to occur and by defining proper measures and testing plans to support the risk mitigation and a successful implementation.
Ideally the digital solution developer should offer the clients to have different environments such as staging where the users can familiarize with the solution, for later on to be supplied with the validation environment after all customizations and configurations are done in order to allow comprehensive testing, and to finally have the productive environment that should be carefully monitored until the validation efforts can be successfully concluded.
An important GMP requirement also applies to digital solutions: change management, where all needs to either update the solution or to fix bugs should be captured by the quality system, meaning that a thorough assessment is necessary, risk based approach applied and ultimately comprehensive testing before implementing new features.
A recurrent concern when we think about digitizing process in how the organizations be protected against data losses. Therefore it is strongly recommended to investigate if the capacity of the chosen digital solution allows data loss prevention as well as and effective backup and data recovery process.
In order for the organizations to really benefit of Data Sciences and Intelligence Revolution advantages, ideally the solutions should be developed in the same platform to allow integration of databases, so that the organizations can really benefit from the intelligence that can be generated using Big Data and Artificial Intelligence concepts.
An active participation of the Digital Revolution requires both the leadership and the organizations to develop a mindset that will allow cope with the initial challenges associated with these new concepts. For an affective decision making process not necessarily more information is needed but a better structure of data, that can generate value through it transformation into information, a synthetic and actionable knowledge. Welcome Digital Revolution!
Wagner Moi is a pharmacist with a master in BA and Quality Engineering. Career developed by working for more than 30 years for large multinational companies such as Merck, Alcon, Nycomed and Takeda, at both operational and corporate levels, in Manufacturing, Quality Control and Quality Assurance. Currently works as COO of Scigenig – Digital Solutions for Pharma and Life Sciences.
