Whitepapers

EMVO Onboarding Guide for Greek & Italian Pharmaceutical Companies

Streamline Your EMVO Onboarding Process with Our Step-by-Step Guide   Designed for pharmaceutical companies in Greece and Italy, our guide simplifies compliance with the European Falsified Medicines Directive (FMD) and ensures seamless integration with EMVO and NMVO requirements.   Why EMVO Onboarding Matters   The European Medicines Verification Organization (EMVO) onboarding...

Read More
Maintaining Mission-Critical Workloads in Pharma Whitepaper Cover

[Whitepaper] Maintaining Mission-Critical Workloads in Pharma

Maintaining Mission-Critical Workloads in Pharma: Free Whitepaper   In the pharmaceutical industry, mission-critical workloadsโ€”like serialization systems, batch records, and compliance processesโ€”are the backbone of your operations. A single disruption can lead to production delays, regulatory risks, and data loss.   Why Mission-Critical Workloads Matter in Pharma   SoftGroupโ€™s free whitepaper, โ€œMaintaining...

Read More

[Whitepaper] Verification & Traceability Guide for Wholesalers

A brief overview of the wholesalers` obligations regarding verification and traceability according to EU FMD requirements.     What is a designated wholesaler?   A designated wholesaler is a company (sales affiliate/licensee/co-marketer and holder of a wholesale distribution authorization), designated through a license/agreement with the Marketing Authorization Holder (MAH) to...

Read More
EUDAMED Updated timeframe

[Whitepaper] EUDAMED Implementation – updated timeframe

  Discover the updated timeframe for implementation of European Database for exchange of medical devices information   Download the whitepaper and find out what is the new timeframe of EUDAMED Implementation, confirmed by European Commission   [formidable id=39]  ...

Read More

[Whitepaper] UDI – from the Basics to the Benefits

  Get the most detailed information about UDI - everything that supply chain participants need to know!   With the implementation of theย Medical Devices Regulation (MDR), it became apparent that manufacturers should assignย UDI to medical devices. This is intended to allow the identification and to improve the traceability...

Read More

[Whitepaper] Key steps towards safe and sustainable pharma packaging

The Pharma industry makes steps towards utilizing sustainable practices in packaging for years.   Due to the complex nature of the industry, the steps are small but definitive towards sustainable packaging. It`s important to mention that the environmental impact of pharma packaging is small compared with other...

Read More

[Whitepaper] Top 10 security advantages of cloud services

Cloud services are gaining traction. Because of their nature, the pharma industry is still looking with disbelief at them. We want to prove to you that the cloud-based solution could be as secure as this on-premises. โ€œThere are two sides to the coinโ€, let`s get...

Read More

[Whitepaper] Checklist – Top MDR questions

  The transitional period to MDR is complex and full of questions - get the answers now!   In 2017 the Medical Devices Regulation (MDR) was published and marked the start of a four-year journey of transition from MDD to AIMDD. From the 26th of May 2021, the...

Read More
mdr questions

[Whitepaper] Frequently Asked Questions About Medical Devices

  The EU's Medical Device Regulation (MDR) was officially published on 5 May 2017 and came into force on 25 May 2017. The MDR will replace the EUโ€™s current Medical Device Directive (93/42/EEC) and the EUโ€™s Directive on active implantable medical devices (90/385/EEC).   In this whitepaper, you...

Read More