Regulatory Electronic Document Management System (EDMS)
The industry is faced with a need to handle increasingly complex regulatory submissions in legacy document management systems. With the prospect of having to adhere to stricter regulatory legislations and industry practices, e.g. IDMP, this presents a challenge which we at HERAX have the expertise to support you in overcoming through the implementation of a state-of-the-art Regulatory EDMS, along with an optimization of your existing process landscape.
By using HERAX as your implementation partner, you will benefit from a Regulatory EDMS that will support your ability to overcome the above challenges through:
- Standardized and controlled masterdata
- Workflows for document review and approval
- Submission package assembly functionality
- Technical interfaces to relevant systems, e.g. RIMS and eCTD publishing
- Archiving and viewing documents and submissions
We assist in managing stakeholders at all levels, training end-users in both the system and the processes, and migrating documents and data from previous repositories, allowing for a successful implementation of a new Regulatory EDMS.
How can we help?
Through HERAX’s extensive experience with selecting and rolling out Regulatory EDMS solutions, we can set you up for a successful EDMS implementation, ensuring a fast and sound benefits realization.
Our experience includes
- A deep understanding of the processes and legislation surrounding the Regulatory Affairs space
- A project methodology for rolling out Regulatory EDMS solutions which has been proven time and again
- An in-depth knowledge of the currently available systems
Your partners in implementation
Optimizing your regulatory submission system and process setup allows your company to meet submission deadlines while adhering to all relevant legislatorial and industry best practice requirements and at the same time ensuring an optimal utilization of resources.
If your company is considering implementing a new Regulatory EDMS solution, please contact us for further information.
We will help you all the way – from initial analysis to successful rollout – and implement on time and budget.