The pharmaceutical industry operates within some of the most demanding regulatory frameworks in the world. As digital transformation accelerates, organisations must safeguard the integrity, authenticity and confidentiality of electronic records. Regulatory frameworks now require this as standard practice.

With regulatory frameworks such as FDA 21 CFR Part 11, GDPR and HIPAA setting strict standards for electronic signatures and digital records, pharmaceutical organisations need a digital signing solution they can trust. SigningHub, developed by Ascertia, offers a secure, scalable and compliant solution designed to meet these stringent requirements.

Understanding FDA 21 CFR Part 11

Title 21 CFR Part 11 is a U.S. Food and Drug Administration (FDA) regulation that sets forth the criteria under which electronic records and e-signatures are considered trustworthy, reliable, and legally equivalent to paper records and handwritten signatures.

This regulation applies to electronic records created, modified, maintained, archived, retrieved or transmitted under any records requirements in line with FDA regulations.

Key requirements of 21 CFR Part 11:

• Validation: Systems used to create, modify, maintain, or transmit electronic records must be validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.
• Audit trails: Actions must be time-stamped, securely recorded and available for inspection.
• Record retention: Electronic records must be retained for as long as required and readily accessible for as long as required.
• Unique E-signatures: Each e-signature must be uniquely assigned to an individual, not reused or reassigned, and linked to their identity and signing intent.

How SigningHub supports compliance with FDA 21 CFR Part 11

SigningHub is designed to meet and exceed the requirements of FDA 21 CFR Part 11, providing pharmaceutical companies with full confidence in their digital record-keeping and signing processes.

System validation

SigningHub ensures system validation by:

• Presenting documents in a flattened image mode to prevent dynamic or malicious code from altering content
• Allowing users to review and fill in form fields before signing
• Re-authenticating users before they apply their unique digital signature

These steps ensure that the system performs consistently and reliably, maintaining the integrity of electronic records.

Secure Audit trails

SigningHub maintains comprehensive audit trails that:

• Record all document interactions, including viewing, signing and modifications.
• Record time-stamped entries to track the sequence of events.
• Are securely stored in a standard format that allows independent viewing and verification through trusted third-party software.

These audit trails support accountability and transparency in electronic record management.

Trusted E-signatures

SigningHub’s electronic signature capabilities align with FDA 21 CFR Part 11 by:

• Ensuring each individual signs using uniquely issued credentials that are securely bound to them and inaccessible to others.
• Verifying the identity of each individual before enabling their signing capability, ensuring signatures are linked to a validated person.
• Capturing the printed name, date and time of the signature, together with the signer’s declared intent, and binding this information cryptographically to the document.

These features ensure that e-signatures are legally enforceable and equivalent to handwritten signatures, aligned with U.S. as well as global pharmaceutical standards.

Going beyond FDA: Addressing global data protection regulations

Pharmaceutical organisations don’t only operate under FDA jurisdiction. They must also comply with regional data protection laws such as the EU’s General Data Protection Regulation and the US’s Health Insurance Portability and Accountability Act (HIPAA).

GDPR compliance

The General Data Protection Regulation (GDPR) sets strict rules for the lawful processing of personal data. Organisations must identify a valid legal basis for processing, which may include consent, contractual necessity or legal obligation depending on the context of the signing task.

Key GDPR principles relevant to digital signing

• Lawful basis of processing: Consent is one possible lawful basis under Article 6(1)(a), requiring it to be freely given, specific, informed and unambiguous. Where special category data is processed, explicit consent is required under Article 9(2)(a).
• Access and portability: Individuals have the right to access their personal data and request its transfer to another provider when feasible.
• Right to erasure: Individuals may request deletion of their personal data when certain conditions apply, such as when the data is no longer required.

SigningHub supports GDPR compliance by embedding Privacy by Design and Privacy by Default principles throughout its architecture and operational processes. The platform applies robust data protection controls, including end-to-end encryption, granular role-based access controls and data minimisation strategies that ensure only necessary personal data is processed within signing workflows. These safeguards help organisations protect personal data, uphold data subject rights and maintain a resilient privacy posture.

HIPAA compliance

HIPAA defines national standards for protecting patient health information. Key requirements include:

• Privacy rule: Safeguarding individuals’ medical records and other personal health information.
• Security rule: Implementing administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and availability of electronic protected health information (ePHI).

SigningHub aids in HIPAA compliance by providing a secure e-signature solution that protects ePHI through encryption, access controls and audit trails.

Data sovereignty and security considerations

Data sovereignty refers to the concept that data is subject to laws and governance structures within the nation where it is collected. Pharmaceutical companies operating globally must ensure that their data handling practices comply with local data sovereignty laws.

SigningHub addresses data sovereignty concerns by:

• Data localisation: Offering deployment options, such as on-premise, that allow data to be stored within an organisation’s own data centre to comply with local laws or hosted in the cloud by a SigningHub partner based in the region.
• Encryption: Utilising encryption for data at rest and in transit, ensuring that sensitive information is protected against unauthorised access.
• Access controls: Implementing role-based access controls to restrict data access to authorised personnel only.

These features give pharmaceutical organisations the flexibility to meet local data sovereignty requirements without compromising on usability or compliance.

Benefits of using SigningHub in the pharmaceutical industry

Implementing SigningHub offers numerous advantages for pharmaceutical companies:

• Regulatory compliance: Supports FDA 21 CFR Part 11, GDPR, HIPAA, and other relevant regulations
• Enhanced security: Provides robust security features, including PKI-based encryption, audit trails and access controls.
• Operational efficiency: Streamlines document handling and approval process.
• Global accessibility: Enables secure access to documents and signing capabilities from anywhere.
• Scalability: Offers flexible deployment options for organisations of varying sizes and needs.

Future-proof your digital compliance strategy with SigningHub

The pharmaceutical industry is evolving rapidly and so are the compliance and security expectations surrounding digital records. With SigningHub, organisations gain a future-ready e-signature platform that delivers:

• Trusted digital signatures backed by accredited certificate authorities
• A secure, audit-ready environment for sensitive data
• Full alignment with regulatory demands across multiple markets

Whether you’re digitising R&D documentation, managing clinical trial approvals, or streamlining regulatory submissions, SigningHub helps you move faster, reduce risk, and stay compliant.

Ready to transform your document signing experience?

Contact us to learn how SigningHub can support your compliance journey or start your free trial today.

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