Driving Compliance in a Digitally Evolving Industry

As life sciences organizations embrace digital transformation, regulators worldwide are emphasizing the importance of data integrity and electronic record reliability. From FDA 21 CFR Part 11 to EU Annex 11, the demand for compliant, traceable, and secure digital workflows has never been greater. Electronic signatures are no longer a convenience — they are a regulated control mechanism ensuring trust, transparency, and accountability in the digital age.

GxP vs. Non-GxP: Why One Size Doesn’t Fit All

While most commercial e-signature tools are built for speed and ease of use, GxP environments—covering Good Manufacturing, Laboratory, and Clinical Practices—are bound by strict validation and audit requirements.
Under these frameworks, each signature must be authentic, attributable, and auditable. This means ensuring verifiable signer identity, intent, and timestamp, while maintaining tamper-evident records throughout the document lifecycle.
For life sciences organizations, adopting a GxP-compliant solution is not optional—it is essential to maintaining product quality, patient safety, and regulatory readiness.

Built for GxP: Nota Sign’s Dedicated Solution

Addressing the limitations of general-purpose signing systems, Nota Sign developed a dedicated GxP Module purpose-built for regulated use cases.

  • The module offers:A dedicated GxP workspace, accessible only to authorized personnel managing Part 11 envelopes.
  • Comprehensive audit trails capturing timestamps, user IDs, IP addresses, and actions in tamper-evident logs.
  • Regulatory-grade signature metadata, including signer’s name, date/time, unique ID, and reason for signing.
  • Two-step identity verification and SSO integration for both internal and external users.
  • Through these controls, Nota Sign elevates digital signing from a simple convenience to a validated compliance mechanism.

The Nota Sign 21 CFR Part 11 Compliance Framework

Nota Sign’s compliance framework is designed to meet the requirements of FDA 21 CFR Part 11 and is aligned with other key international standards relevant to data security and privacy in regulated environments. The solution is designed around a shared responsibility model, ensuring clear ownership between platform and customer:

  • Nota Sign (Platform & Services): Provides secure infrastructure, identity authentication, access management, audit trails, encryption, system change controls, and recovery mechanisms—along with documented validation evidence (release notes, test summaries, and change records).
  • Customer (Processes & Configuration): Defines SOPs for identity verification, data retention, and system access; performs risk-based intended use validation; and manages lifecycle controls for user accounts and records.

This transparent compliance collaboration ensures that regulated companies can confidently deploy Nota Sign as part of their validated quality system.

Empowering Digital Transformation in Life Sciences

By replacing paper signatures and outdated systems, life sciences organizations gain not only compliance, but also efficiency, transparency, and data integrity.
Nota Sign enables secure, multi-level e-signature capabilities (SES, AES, QES) and integrates seamlessly with enterprise systems—helping GxP teams accelerate global collaboration without compromising regulatory assurance.
As the industry shifts toward AI-assisted validation and global regulatory convergence, Nota Sign stands as a trusted partner—delivering compliance that scales with innovation.

Enabling End-to-End Efficiency Across the Value Chain

In the life sciences ecosystem, Nota Sign supports critical documentation processes including equipment qualification, clinical trial agreements and informed consents, batch records, deviation reports, and material release forms — all under compliant, traceable workflows.
Beyond GxP operations, Nota Sign also extends to enterprise functions such as HR, procurement, legal, and finance — creating a unified signing and document management experience across the organization.
By digitizing complex approval cycles, life sciences companies can significantly shorten review timelines, reduce operational risks, and strengthen audit readiness—driving faster innovation cycles and smarter, compliance-led decision-making.