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The ‘single place of truth’ concept

The ‘single place of truth’

Our philosophy is that each piece of data should be entered only once, and then linked to or inherited from all the other pieces of data that it relates to.

The database and structures within Samarind RMS ensure that duplication of data entry is avoided. This significantly improves the quality of your regulatory information and helps achieve and maintain regulatory compliance.

All our modules are parts of the same fully-integrated system and share a single data repository. We simply ‘turn off’ any modules that are not required. When all the modules are turned on, you have a single solution that encompasses –

  • your ‘master data’, for both pharmaceutical and medical device products, sharing information when appropriate
  • regulatory planning and tracking to manage regulatory activities for registrations, products and more
  • med info and drug safety, allowing timely and efficient processing of medical enquiries and reporting of adverse reactions
  • plus the collation and submission of data and documents to the relevant agencies
    • XEVMPD/IDMP to the EMA
    • eCTD/NeeS/VNeeS to your national or regional authority
    • UDI information to the FDA’s GUDID database
    • ICSRs to and from all stakeholders.

We even include an electronic document management system (EDMS) for those who do not have (or don’t want to use) an already-implemented third-party EDMS and wish to manage their documents in a properly controlled environment.

This ‘single place of truth’ approach means that once your data is in Samarind RMS, it’s simple, quick and easy to create things like an eCTD or your XEVMPD submission. And, because everything is in one system, there’s no confusion regarding where to look for the information, which information is up to date or who shares the responsibility for keeping it accurate.

With other solutions, you often have different programs to go into to do the different activities and data has to be re-entered multiple times. Even those that profess to be ‘integrated’ are often held together with complex synchronisation processes behind-the-scenes, a strategy that can be fraught with difficulties and result in inconsistencies that require frequent administrator tidy-up.

The Samarind ‘Single Place of Truth’ (SPoT) concept avoids all these difficulties elegantly and efficiently, and this is why we call this “the smarter way” of handling your product information.

The Benefits

Data is entered only once;

  • Time saving
  • Excellent data quality
  • Easy and consistent reporting
  • Supporting compliance

Everything within a single system;

  • One system to validate
  • One system to manage
  • Accessible to all users
Contact us for a demo now!