Ennov Compliance platform
Data Management Software
- Data and metadata based model
- Single data repository that spans traditional silos
- Monitoring of Data Consistency
- Full Data Change Control process
Data Management: The Challenges for Regulatory Compliance
Regulatory compliance operations in the pharmaceutical industry are increasingly oriented towards the management and control of data, along with documents. The boundary between the two domains is becoming clearer: the document is there to carry meaning, not to be the vehicle for data, which has its own existence, life cycle and importance.
This was already true and known for a long time in clinical studies and pharmacovigilance. The basis of the clinical trial, especially electronic, is Data Management, i.e. the constitution and organization of the data to be collected in the framework of the trial. Pharmacovigilance, on the other hand, is organized around data collection (Data Entry).
Now, with the rise of standards such as the IDMP, data management has become an integral part of regulatory affairs. Any modern MDR system must be able to manage and associate data: molecule, substance, product, manufacturer, etc.).
Reporting needs, which are more and more widely shared within pharmaceutical companies, imply that in many other fields, such as Quality, data can be stored and managed to be finally analyzed.
In short, data control is becoming the touchstone for regulatory compliance management software. It is one of the fundamental components of the Ennov platform.
What Data Must Be Managed?
Depending on the target system, the data to be managed will vary, but the data related to the product is central in all areas: name, trade name, dosage, active ingredient, therapeutic indication, galenic form, etc. In addition, there are data specific to each field: information relating to the patient (age, sex, weight, height, etc.) for clinical trials and pharmacovigilance; or information relating to the marketing of the product for regulatory affairs (type of procedure, date of marketing authorization, date of renewal, etc.). The overall data model can be very complex and sophisticated.
The IDMP is the most sophisticated and ambitious expression of it that has been designed. Ennov has implemented it in its solution.
Data Management and Single Repository
The Ennov platform relies on a unified and unique data repository, shared by all modules of the software. Data is stored only once and made available to all services and software that need to use it. This guarantees data homogeneity, as it is no longer necessary to manage silos and reconcile data from multiple sources. All of this contributes to increased confidence in the data within the organization, which has a direct impact on operational performance.
But managing data doesn’t just mean storing it. It also means being able to create associations between data (for example, the molecule and the products it is part of); to manage these associations (what happens if I remove this molecule?); and to control the data update process (who can create or delete data, according to what rules and with what validation). All these actions guarantee data integrity (Data Consistency).
Ennov allows the definition of inheritance rules between objects that are linked to each other in order to reinforce data consistency. The solution also offers strong capabilities to manage the data change process. Thus, Ennov ensures a perfect data consistency, even in the context of the very complex IDMP model.
How Does it Relate to MDM?
Data must be shared between different departments, activities and systems. This data can be considered as a central asset of the company, whose control, or lack of control, has direct consequences on its ability to operate effectively in its market. However, as we have also seen, the interactions between data obey extremely complex models.
As a result, Master Data Management projects are essential for many companies in the pharmaceutical sector. The aim is to set up data management systems to ensure that data is consistent and relevant to all the uses to which it can be put within the company. MDM solutions define, data by data, which system is the master, which system is the slave, and how the data are linked together.
Ennov will be able to rely on an MDM when it is in place, in order to provide or consume data. When there is no MDM, Ennov’s RIM can perform this function.
Ennov’s unified compliance platform is a highly configurable software architecture that combines business process management, document management, data/forms management, learning management and business intelligence to form the foundation on which our applications are constructed.