Ennov software

All types of documents can be managed in the same Ennov database: Quality, Regulatory, but also R&D, Clinical, Engineering, Legal or Marketing. Each document has an ID form associated with it, it includes a set of metadata fields and displays the document history. Field values are used to classify, filter and search documents. It is then very easy to structure the documentation and navigate in it; there is no need to create multiple databases, one for each domain. Document hierarchies can be set differently for each unit; users then access the content that is related to their function or interests.

The Ennov platform includes its own workflow engine that provides advanced capabilities. Workflows are used in Ennov Training, Ennov eTMF and Ennov RIM. They allow control of the sequencing of tasks and data modification while providing visibility across the organization.

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.

Encouraged by Health Authorities, many life sciences companies have adopted risk-based approaches throughout the organization. But effective risk management programs require data to identify the trends and outliers that can help companies anticipate and mitigate risk. Often, that data exists in multiple places, creating a burden on those who are responsible for gathering, aggregating and interpreting it.