Complete Form and Esign

This video details the precise, regulated workflow required for completing and applying a compliant electronic signature (e-sign) to a PDF form within the SureClinical eTMF (Electronic Trial Master File) system. The process is designed to ensure data integrity, maintain a robust audit trail, and meet the stringent requirements for electronic records and signatures common in pharmaceutical and life sciences operations, particularly those adhering to regulations like 21 CFR Part 11. The tutorial emphasizes the necessary steps for secure identity verification and document finalization, which are crucial for documents related to clinical trials, regulatory submissions, and quality management systems.

The workflow begins with an external notification, typically via email or text message, prompting the user to complete a pending task. Upon logging into the SureClinical platform, the user is presented with a task notification dialogue box outlining a multi-step process: download, complete, upload, and sign. A key operational detail is the requirement to download the PDF form and complete it externally using Adobe Reader. This hybrid approach—leveraging a trusted third-party application for form completion before returning to the regulated system—highlights the need for interoperability and the reliance on established PDF standards for data capture in GxP environments. Once completed and saved locally, the user returns to SureClinical to upload the finalized document.

The final and most critical phase involves the electronic signing process, which incorporates strong identity verification methods. After selecting the document within the platform, the user is prompted to initiate the signing sequence by requesting a verification code, delivered via email or text message. This code, combined with the user’s personal signing PIN, constitutes a two-factor authentication method, satisfying regulatory requirements for secure electronic signatures. Furthermore, the user must select a specific "reason for signing" the document, which provides the necessary context and intent required for regulatory acceptance. The video concludes by highlighting the use of an Adobe digital ID provided by SureClinical, ensuring that the resulting digital signature is instantly and globally verifiable by anyone using Adobe Reader, a non-repudiation feature essential for regulatory compliance and long-term record retention.

Key Takeaways: • Regulated e-signature workflows necessitate a multi-step process that begins with external notification and ends with verifiable digital authentication, ensuring every action is logged for audit purposes. • The workflow described utilizes a hybrid approach where form completion is handled offline using industry-standard software (Adobe Reader) before the document is uploaded back into the regulated eTMF system for finalization. • Compliance with electronic signature regulations (such as 21 CFR Part 11) is achieved through two-factor authentication, requiring both a unique, time-sensitive verification code (sent via email/text) and a static personal signing PIN. • The system requires users to explicitly select a "reason for signing" the document, which captures the necessary context and intent, a mandatory component for regulatory acceptance of electronic records. • The use of an Adobe digital ID is crucial for establishing non-repudiation, guaranteeing that the digital signature is instantly verifiable worldwide, which simplifies regulatory inspections and ensures long-term document integrity. • Upon uploading the completed form, the SureClinical platform employs an "automated workflow instrument" to prefill metadata about the document, streamlining the process while ensuring data accuracy and automated tracking. • The reliance on external PDF completion (Adobe Reader) suggests a potential gap in native, browser-based form-filling capabilities within the eTMF platform, an area where custom software development firms could offer integrated solutions. • The entire process is designed to create a comprehensive audit trail, recording the time stamps of the download, upload, verification code request, and final signature application, satisfying GxP documentation requirements. • For IntuitionLabs, this workflow demonstrates the high security and verification standards required for any AI or automation solution interacting with clinical or regulatory data, emphasizing the need for secure APIs and compliant data handling practices. • The video implicitly warns against using non-validated or non-secure signing methods, reinforcing that only signatures backed by verifiable digital IDs and multi-factor authentication are acceptable in the life sciences sector.

Tools/Resources Mentioned:

• SureClinical (eTMF platform)
• Adobe Reader (Used for offline PDF form completion)

Key Concepts:

• E-sign (Electronic Signature): A legally recognized method of signing documents electronically, requiring specific controls (like verification codes and PINs) in regulated industries to ensure authenticity and non-repudiation.
• Adobe Digital ID: A certificate-based digital identity used to create verifiable digital signatures that are globally recognized and trusted, crucial for regulatory submissions.
• Automated Workflow Instrument: A feature within the SureClinical platform that automatically extracts and prefills metadata about an uploaded document, ensuring consistency and accuracy in the audit trail.
• Signing PIN: A personal identification number used in conjunction with a verification code to provide two-factor authentication for electronic signatures, meeting 21 CFR Part 11 requirements.