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Regulatory Affairs Transformation brings you into the future

Regulatory Affairs requires an IT set-up that copes with the increasing complexity and makes it easier to manage. By changing to a unified platform, you break down your silos, structure your data and optimize your entire business model.

​​​​​​​What is Regulatory Affairs Transformation?
Over the past decade, Regulatory Affairs has been undergoing a significant change. Technology has evolved, but with increasing requirements from authorities, it has been challenging to keep up with technological innovation and has led to complex and costly IT management. Most RA architectures have fallen behind on technology, hence not reaping the benefits of innovation and IT optimization.

Most RA departments operate individual, but not connected IT applications, such as Electronic Document Management System (EDMS), Electronic Common Technical Document (eCTD), Regulatory Information Management System (RIMS) and labeling systems to embrace the many varied tasks involved in RA.

However, while these IT solutions for the different RA processes may be robust, they have developed individually, resulting in the creation of many closed-off and expensive “silos” of data. These silos are counter-productive to what really matters: Getting new products to the market.

With a unified platform it is possible to transform Regulatory Affairs processes by merging these systems into that platform, improving both compliance and operational efficiency.

What are the benefits of digital transformation in RA?
Having many silos inhibit the access to data and ultimately results in unrealized potentials for market development. RA transformation challenge this paradigm.

In concrete terms, the benefits of RA transformation are:

  • From documents to data. EMA and FDA are increasingly requesting submission of structured data in addition to documents. RA transformation will bring documents and data together so that the information in the submissions is aligned and transparent, regardless of the format and across the application landscape.

  • Agile data sharing with other business areas. RA and the company's other areas such as Clinical, Manufacturing and Pharmacovigilance can more easily exchange and re-use data to support business processes and the regulators’ enquiries.

  • Easier external collaboration. Collaborating with various external stakeholders such as service providers, consultancies, regulators and partners will become easier and more time efficient in a unified platform.

  • RA Analytics. With separate systems and scattered data, it is difficult to maintain the management oversight of regulatory operations activities. By contrast, RA transformation will allow for better analytics with the purpose of identifying challenges and bottlenecks in the RA processes.  

Drop the silos – let processes work together

By changing to a unified platform, the entire process landscape supported by today’s EDMS, RIMS, eCTD and Labeling systems can be covered by the platform. It will take time to break down the silos and transition from the current systems, but the benefits of transforming RA are both operational and strategic and will prepare you for the future challenges in RA.

NNIT as your RA integration partner

NNIT has more than 20 years of experience in RA systems, and NNIT possesses expert knowledge in the field of RA transformation. NNIT understands how an RA department works in order to make this transformation a success with the RA users.

NNIT will make the transition to a unified platform possible through consulting, mapping, data migration, implementation and execution. NNIT will also guide you through the entire process and help you activate your regulatory data to support the submission processes.

Here is how NNIT approaches the task:

  • Strategy. We help to create a clear vision with a Road Map for the whole process.

  • Program. We help you to identify stakeholders, select projects, and design your business case.

Once the overall master plan is in place, the process begins with EDMS, RIMS, publishing or labeling.
Each system then needs to go through these three phases to make the processes converge:

  • Analyze

  • Design

  • Execute

Ultimately, this will give your company the right platform and governance for managing all RA information.

 

 

 


 
 

 

 

Rune Bergendorff+45 3075 1747 rrb@nnit.comManaging Consultant - Life Sciences Advisoryhttps://dk.linkedin.com/in/rune-bergendorff-5160272bRune Bergendorff

 

 

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