Managing regulatory information is a complicated task that demands multitasking capabilities, knowledge of local requirements and regulatory business processes – so why not unify and simplify? When time comes for transitioning towards a more unified RIM platform, ready to tackle the XEVMPD demands, NNIT Veeva Powerhouse is by your side.
Submitting regulatory data for instance XEVMPD to the EMA (European Medicines Agency) has been a recurring task for life sciences companies for years.
But instead of streamlining the submission of data, businesses today face a regular cacophony of demands when it comes to regulatory data.
RIMS: Keeping up with compliance
Today, the life sciences industry is not only juggling with the XEVMPD requirements but also see other European requirements on data use and data quality from for instance SPOR and Falsified Medicines Directive emerging. Other, including foreign, regulatory agencies are also requesting data – like SPL requirements from FDA and internal compliance require capabilities for data reuse like data standardization and master data initiatives.
Keeping one’s data under control and maintained is an omnipresent challenge. Making sure you have an overview and access to the right data demands that life sciences companies take a more agile stand towards the issue instead of relying on yesterday’s silos and stand-alone applications.
The scourge of duplicates
Breaking out of established protocols and switching to a unified platform has several benefits – a major one being able to rid your organization of duplicate data.
The Veeva Vault RIM Suite lets you handle all your regulatory information needs within a single system, connected to the unified platform that is Veeva Vault. Thus, you only need to store your information once, but still can utilize it throughout the business.
With Veeva Vault, your company will be able to store the data in a format that suits your business, while simultaneously mapping and translating the data for different purposes. For example, tailored to different compliance demands or regulatory requirements. All without ceding control of your data to third parties.
Already a Veeva user? It’s time to collect your regulatory data in one place
If you already have Veeva are you then aware of the possibilities provided by the releases with regards to XEVMPD? Submitting to XEVMPD is an integrated part of Veeva Vault providing a seamless data process for your regulatory data and a variety of possibilities for use of data throughout the business.
If your RIMS already hold compliant regulatory data, it is basically handled by the push of a button.
Utilizing a powerhouse
While Veeva Vault brings a unified platform to the table, NNIT brings the expertise and understanding of life sciences – we call it NNIT Veeva Powerhouse.
Our many years as a service provider to the life sciences sector mean that we not only understand the complexities of drug product registration but also the, at times, difficult process of being vigilant as well as compliant.
• make sure your Veeva Vault is used to its full capabilities – from regulatory planning to tracking of lifecycle activities
• assist you in setting up the application, processes and data needed to support xEVPMD data submission from your Veeva Vault
• secure that your configuration needs are mapped and fitted into your Vault to support regulatory requirements and de facto data standards like IDMP
• configure reports to provide regulatory KPIs, product data required for the EMVO database (supporting the legal framework of Falsified Medicines Directive) or weekly reports on regulatory status to mention a few
• perform gap assessments on your Vaults capability to support new requirements and provide solution proposals
• help to establish the data quality needed i.e. for XEVMPD
• update existing procedures or establish new to ensure governance is in place
The first step
Implementing a new RIMS or changing your XEVMPD submission process may seem like a lot of work, but it doesn’t have to be.
NNIT Veeva Powerhouse is your partner in the process, helping you every step of the way while implementing RIMS and any other of the 11 different applications housed within Veeva Vault.
We see it as essential that business and IT can communicate – and with one foot planted in the role as a service provider and the other as a life sciences expert we’re able to mediate between the two.
As NNIT Veeva Powerhouse we use this expertise to guide the customer in getting the full value out of their Veeva Vault investment, while continuously helping them to reconfigure the system to match specific business needs. Whether it’s configuring the RIMS to streamline the XEVMPD process or in time making the shift towards IDMP or PMS, we’re by your side securing a smooth and functioning transition.
Facts: XEVMPD – Life sciences regulatory companion
• XEVMPD stands for “Extended EudraVigilance Medicinal Product Dictionary” and has since 2012 been a mandatory add on to the earlier “EudraVigilance Medicinal Product Dictionary”, which was established in 2005.
• In short, it requires companies with marketing authorization holder responsibilities to submit regulatory data on products intended for humans to the European Medicines Agency (EMA).
• XEVMPD has been in place since July 2012 following the legal requirements introduced by the Article 57(2) of Regulation (EC) 726/2004 was enforced.
• Today, XEVMPD is just one of several processes, life sciences companies go through in order to keep their products and business compliant in different markets.