Attending the Farmaforum event with our partner Camerfirma was a fantastic opportunity to engage with people across the sector. The discussions reaffirmed the increasing relevance of secure digital transactions in a highly regulated industry, where compliance, security, and operational efficiency are key.
At Ascertia, we specialise in delivering digital trust solutions, while Camerfirma’s expertise as a Qualified Trust Service Provider (QTSP) under eIDAS ensures that our joint offerings meet the strict regulatory demands of the European Union (EU).
In this blog, we explore how Ascertia and Camerfirma help pharma companies stay compliant with eIDAS, streamline operations, and ensure the integrity of cross-border transactions. We also highlight real-world use cases and discuss the future of digital trust in this integral sector.
Introduction to Ascertia and Camerfirma
About Ascertia
Ascertia is a global leader in providing trusted digital trust solutions, with a particular focus on e-signature and PKI-based identity verification. We enable organisations to digitise their processes with confidence by offering robust, eIDAS-compliant solutions that ensure secure, legally binding transactions.
Our flagship product, SigningHub, is widely adopted across industries that require top-tier security and compliance, including the pharmaceutical sector. SigningHub supports a full range of e-signature options—from simple to qualified electronic signatures (QES)—making it the ideal solution for organisations that need to comply with regulatory requirements across borders.
About Camerfirma
Camerfirma is one of the leading QTSPs in Europe, offering services such as:
- Digital certificates
- Authentication
- E-signatures
As a QTSP under eIDAS, Camerfirma delivers trusted services that are fully compliant with EU regulations, ensuring secure and legally valid transactions.
By partnering with Ascertia, Camerfirma brings its deep understanding of digital identity and eIDAS expertise to pharmaceutical organisations that need to ensure the highest levels of compliance in their cross-border operations.
How Ascertia and Camerfirma support eIDAS compliance in the pharmaceutical sector
Cross-border e-signature solutions
Pharmaceutical companies often operate across multiple jurisdictions, requiring seamless cross-border transactions and regulatory filings. The eIDAS regulations provide a standardised framework that ensures electronic signatures are legally recognised across all EU member states.
At Farmaforum, we highlighed how Ascertia and Camerfirma work together to provide eIDAS-compliant e-signature solutions that facilitate:
- Cross-border collaborations
- Regulatory submissions
- Clinical trials
Our Qualified Electronic Signatures (QES), which hold the same legal weight as a handwritten signature, allow pharma companies to execute legally binding agreements, contracts, and research documents, regardless of the EU country involved.
By utilising QES, pharmaceutical companies can be confident that their digital documents will be recognised as legally valid throughout the EU. It reduces the risk of regulatory non-compliance and ensures a smooth, secure process for conducting business across borders.
Integration with pharma-specific workflows
One of the key challenges raised during the event was the need for e-signature solutions that integrate seamlessly into pharmaceutical workflows, including:
- Clinical trials
- Patient consent
- Regulatory filings
- Supply chain management
Our solutions are highly adaptable and can be integrated into existing pharma-specific software, ensuring digital transformations enhance operational efficiency without disruption.
For instance, SigningHub can be configured to work with document management systems (DMS) or enterprise resource planning (ERP) tools widely used in pharma research, clinical trials, and submissions. This means that signing and verifying documents within these systems becomes a secure, compliant, and frictionless process.
Security and trust
The pharmaceutical industry handles sensitive information daily, from patient data to proprietary research and drug development details. Ensuring that this information remains secure is critical for maintaining patient confidentiality and safeguarding intellectual property (IP).
Ascertia and Camerfirma’s eIDAS-compliant solutions deliver a high level of security, including features such as:
- Data encryption
- Tamper-proof e-signatures
- Secure timestamping
These features ensure the integrity, confidentiality, and non-repudiation of all signed documents, making them ideal for managing clinical trial data, electroni c submissions, and cross-border research collaborations.
By securing the digital signatures and ensuring documents cannot be altered after signing, our solutions help pharma organisations meet the stringent regulatory standards they are subject to.
Benefits of using Ascertia and Camerfirma e-signature solutions
Ensuring legal validity across borders
With the EU’s diverse regulatory landscape, pharma companies face challenges in ensuring that their digital documents meet the legal requirements of each member state.
Ascertia and Camerfirma’s QES solutions are fully compliant with eIDAS, ensuring e-signatures are legally valid and enforceable across the EU. This cross-border recognition reduces legal risks and helps pharmaceutical companies avoid costly compliance issues.
Simplifying regulatory submissions
Pharmaceutical organisations often need to submit vast amounts of data to regulatory bodies such as the European Medicines Agency (EMA). Our eIDAS-compliant solutions streamline these regulatory submissions, ensuring documents are securely signed, time-stamped, and compliant with relevant legal frameworks.
This reduces the administrative burden and ensures submissions are accepted without delays, accelerating time-to-market for new drugs and treatments.
Enhancing operational efficiency
By digitising signature process with eIDAS-compliant e-signatures, pharma companies can significantly reduce time spent on paper-based systems. Not only does this help minimise administrative burdens, but also leads to faster document processing and cost savings.
Digitising approvals and signatures for clinical trials, patient consent forms, and supply chain documents ensures organisations move forward without unnecessary delays, enabling companies to focus on innovation and patient care.
Real-world use cases
Clinical trials and research
Clinical trials accumulate significant amounts of data, and obtaining patient consent is a vital element. Ascertia and Camerfirma’s solutions enable secure digital signatures on electronic consent forms. It ensures that they are legally binding and eIDAS-compliant.
These signatures are also used for handling patient data securely and collaborating across borders in multi-country research initiatives.
Regulatory filings and submissions
Submitting drug approvals and research data to EU regulatory bodies is a complex and highly regulated process.
By using Ascertia and Camerfirma’s QES solutions, pharma companies can ensure that these documents are compliant and securely signed and recognised across borders. This helps reduce delays in regulatory approvals, getting life-saving drugs to the market faster.
Supply chain authentication
In the pharmaceutical sector, ensuring the authenticity of documents across the supply chain is crucial for preventing counterfeiting and safeguarding product integrity.
eIDAS-compliant e-signatures secure the entire supply chain, from manufacturing contracts to distribution agreements, ensuring all parties can trust the authenticity and legality of signed documents.
Future trends: Digital transformation in pharma with eIDAS
Adoption of digital trust services
As the pharmaceutical industry continues to embrace digital transformation, the use of eIDAS-compliant digital trust services will become increasingly critical.
Ascertia and Camerfirma are at the forefront of this movement, providing the tools the pharma sector needs to stay compliant, secure, and efficient in a digital-first world.
Potential updates in eIDAS regulation
Looking ahead, eIDAS itself is set to undergo updates to further strengthen digital identity and trust services across the EU.
Ascertia and Camerfirma are committed to staying ahead of these changes, ensuring our solutions remain compliant with evolving regulations and continue to meet the needs of the pharmaceutical industry.
Moving forward with trusted e-signature solutions in pharma
Ascertia and Camerfirma’s eIDAS-compliant e-signature solutions provide pharmaceutical companies with a secure, compliant, and efficient way to manage cross-border transactions, regulatory submissions, and supply chain processes.
By ensuring legal validity, streamlining operations, and enhancing security, our solutions empower pharma companies to succeed in an increasingly digital landscape.
To stay competitive and compliant, now is the time to adopt Ascertia and Camerfirma’s trusted e-signature solutions. Contact us to explore how we can support your organisation’s digital transformation and ensure success in the fast-evolving pharmaceutical industry.
