On 26 September 2024, we will be attending the Farmaforum event with our partner Camerfirma, connecting with key stakeholders in the pharmaceutical industry.
One of the critical topics we hope to discuss is the importance of secure and compliant digital transactions under the European Union’s eIDAS Regulation (Electronic Identification, Authentication and Trust Services).
In an era where cross-border collaborations, digital research, and regulatory submissions are essential to pharmaceutical operations, ensuring trust and security in these digital transactions is vital. EIDAS provides a common legal framework for electronic transactions across EU (European Union) member states, making it highly relevant to the pharmaceutical industry.
In this blog, I will outline how eIDAS-compliant electronic signatures (e-signatures) can significantly contribute to pharmaceutical compliance and how Ascertia’s solutions can address the industry’s unique challenges.
The eIDAS Regulation establishes a standardised framework for electronic identification and trust services throughout the EU. Its primary goal is to create a trustworthy digital ecosystem, enabling individuals and organisations to engage in secure, cross-border electronic transactions.
By providing a legally binding and secure mechanism for identifying parties and authenticating electronic documents, eIDAS has transformed the way businesses operate across borders.
For the pharma industry, which is highly regulated and spans multiple jurisdictions, eIDAS plays a crucial role. Companies involved in drug development, clinical trials, and supply chain management regularly need to collaborate with partners, regulators, and researchers across the EU.
In these scenarios, the need for secure, compliant digital transactions is more important than ever. Regulatory submissions, clinical data exchanges, and cross-border approvals require stringent security measures to ensure:
eIDAS helps streamline these processes by offering a standardised approach to e-signatures and trust services, making it easier for pharmaceutical companies to maintain compliance while improving operational efficiency.
One of the key components of the eIDAS framework is the use of e-signatures to authenticate digital documents and transactions. eIDAS recognises three types of electronic signatures, each offering a different level of security and legal assurance:
The pharmaceutical sector faces significant challenges in ensuring that digital documents remain secure, compliant, and legally binding. For instance, clinical trials generate vast amounts of sensitive data that needs to be authenticated, timestamped, and stored securely.
Ensuring the integrity of this data is vital, not only for regulatory compliance but also for maintaining the trust of patients, researchers, and regulatory bodies.
Similarly, regulatory submissions involve the exchange of sensitive information between pharma companies and regulators across borders. E-signatures help streamline this process by providing a secure, compliant method for signing and authenticating digital documents.
In addition, supply chain management in pharmaceuticals requires the secure exchange of contracts, agreements, and certifications. EIDAS-compliant e-signatures ensure these documents are tamper-proof and legally binding, reducing the risk of disputes and facilitating smooth operation of the supply chain.
Despite the clear benefits, integrating eIDAS-compliant solutions into existing pharma workflows can be challenging. Pharmaceutical companies often operate with complex IT systems and legacy software, making seamless integration a significant concern.
At Ascertia, we understand these challenges and work with our partner, Camerfirma, to offer customisable eIDAS-compliant solutions that integrate smoothly into your existing infrastructure.
We’ve designed our solutions to work with various pharmaceutical software platforms, including those used for clinical trials, regulatory submissions, and supply chain management. By offering flexible APIs and dedicated support, we ensure your organisation can easily implement e-signatures without disrupting daily operations.
Beyond eIDAS compliance, our solutions ensure broader compliance with other critical regulations, such as the General Data Protection Regulation (GDPR). This comprehensive approach helps pharma companies meet multiple regulatory requirements, ensuring that both data security and privacy are maintained.
As we prepare to attend the farmaforum event, we’re eager to engage with key stakeholders in the pharmaceutical industry to explore how eIDAS-compliant solutions can drive the industry’s digital transformation.
With the growing focus on compliance, security, and the increasing demand for efficient cross-border digital transactions, it’s clear that eIDAS will play a pivotal role in shaping the future of this integral industry.
At Ascertia, we are well equipped to meet these evolving needs with our comprehensive range of solutions. We designed products like SigningHub and ADSS Signing Server to deliver the highest levels of security and compliance, supporting Qualified Electronic Signatures (QES) and integrating seamlessly into existing pharma platforms.
SigningHub, for example, excels in managing and executing e-signatures within complex workflows, while ADSS Signing Server offers robust validation of digital signatures and timestamps, ensuring document integrity and authenticity throughout the process.
We anticipate insightful discussions at Farmaforum and look forward to understanding the specific challenges the sector faces. Our solutions not only meet eIDAS standards, but also adapt to the stringent regulatory demands of the pharmaceutical industry.
Ascertia’s offerings provide comprehensive compliance, including alignment with GDPR, ensuring companies can trust their digital transactions across the entire European market.
We’re excited about the potental for collaboration and confident that Ascertia’s trusted digital signature and verification solutions will help pharma organisations remain secure, compliant, and efficient as they continue to embrace digital transformation.
Learn more about ADSS Signing Server and SigningHub, or get in touch to discuss your organisation’s unique requirements.