Integrating Documentum and Ennov RIM
Learn how Ennov RIM and Documentum can operate effectively together in an enterprise system architecture.
January 19, 2021
Unified PV and RIM
Learn how Ennov RIM and Ennov PV are used to enable the efficient production of Periodic Safety Update Reports
January 19, 2021
Pharmacosmos Adopts Ennov to Support Quality/GxP Operations
Ennov are pleased to announce that the Danish pharmaceutical company Pharmacosmos has implemented Ennov Doc and Ennov Training for the management of their global Quality
January 19, 2021
Ennov Announces the Expansion of the Regulatory Team
Ennov is pleased to announce the addition of Steve Clark to our team of Regulatory experts. Steve has over 20 years of global Regulatory operations
January 19, 2021
Smart Signal Management in Pharmacovigilance
The evaluation of safety signals should be a continuous process in pharmacovigilance and it is essential that Manufacturing Authorization Holders (MAH’s) have a well-defined process to capture, evaluate,
January 19, 2021
Clinical CAPAs: Are Your Trials in a State of Control?
The MHRA Inspectorate Blog recently posted a post [i] discussing Corrective and Preventive Actions, the importance of root cause analysis, and what triggers inspectors to
January 19, 2021
Preparing for IDMP: Insights from the Gens & Associates survey
Recently, I reviewed the results of the Gens & Associates’ World Class RIM Survey. There is a wealth of great information on RIM investments, benefits, practices,
January 19, 2021
FDA Issues Final Guidance on Civil Money Penalties Relating to ClinicalTrials.gov
FDA has issued a final guidance document on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank. This draft guidance was first issued in 2018
January 19, 2021
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