Top 7 Reasons Regulated Industries Trust MSB Docs for 21 CFR Part 11 Compliance

In the highly regulated world of life sciences, compliance isn’t just about checking boxes—it’s about saving time, reducing risks, and ultimately advancing innovations that can change lives. Did you know that a single non-compliant document could delay a life-saving drug by months? Managing documents and signatures efficiently while adhering to 21 CFR Part 11 and GxP standards is mission-critical for life sciences organizations.

For over a decade, MSB Docs has been a trusted leader in healthcare and life sciences, offering cutting-edge eSignature solutions that empower organizations to ensure compliance, optimize workflows, and focus on what matters most—innovation.

1: Deep Expertise in 21 CFR Part 11 Compliance

MSB Docs provides a purpose-built eSignature platform that aligns seamlessly with 21 CFR Part 11 regulations, enabling life sciences organizations to meet FDA compliance requirements confidently.

Key Features:

• Tamper-Evident Audit Trails: Every document includes a time-stamped, tamper-evident audit trail to ensure data integrity and transparency during regulatory reviews.
• Role-Based Access Control: Assign roles and permissions to ensure only authorized personnel access or modify sensitive documents.
• Enforced Compliance: MSB Docs’ 21 CFR Signature Policy enforces compliance with 21 CFR Part 11 automatically, ensuring that document custodians make no mistakes when collecting a 21 CFR Part 11 signature.
• Pre-Validated Platform: MSB Docs delivers pre-validated solutions that expedite acceptance for compliance with 21 CFR Part 11 and GxP requirements, saving you both time and money. Our validation package includes requirements which are clearly mapped to the CFR, test results with objective evidence, and more. This is included in your 21 CFR package at no additional cost to you.

Real-Life Scenario:

Imagine a clinical trial involving hundreds of participants across the globe. Managing patient consent forms, investigator agreements, and regulatory submissions manually is not only daunting but error prone. MSB Docs simplifies this process with automated workflows and centralized document management, ensuring every step is compliant and efficient, even as teams scale.

2. Secure and Global eSignature Capabilities

The life sciences industry requires not just compliance but also the highest level of data protection. MSB Docs offers robust, globally recognized security protocols to protect sensitive data during the signing process.

What Sets MSB Docs Apart:

• 🔒 AES 256-Bit Encryption: Ensures the confidentiality of all documents and signatures.
• 🌍 Global Compatibility: Multilingual support to meet regional compliance needs.
• Multi-Factor Authentication (MFA): Verifies signer identity, providing additional layers of security.
• eIDAS-Compliant Digital Signatures: Supports advanced electronic signatures, enabling compliance with global regulations.
• Geo-Redundant Data Centers: Guarantees data availability and reliability, critical for multinational clinical trials.

This comprehensive approach ensures that organizations can handle both local and global compliance requirements effortlessly.

3. Simplified Workflow Automation for Life Sciences

Life sciences organizations often juggle complex workflows involving multiple stakeholders, from researchers and regulators to patients and clinical sites. MSB Docs simplifies these workflows through advanced automation.

Workflow Benefits:

• 📊 Advanced Reporting Tools: Gain actionable insights into your document workflows.
• Pre-Configured Templates: Ready-to-use templates for patient consent forms, clinical trial agreements, and protocol approvals.
• Automated Notifications: Reduces manual follow-ups by sending automated reminders to signers and stakeholders.
• Seamless API Integrations: Connects with CTMS, LIMS, ERP, and other systems to create an end-to-end digital ecosystem.
• Regulated vs. Non-Regulated Workflows: Easily switch between workflows to manage both 21 CFR Part 11 and general business processes.

Data-Driven Insight:

Studies show that esigning solutions can reduce administrative costs by up to 60% while improving turnaround time by 70%. With MSB Docs, life sciences organizations can automate tasks that were once time-consuming, enabling them to focus more on their core research efforts.

4. Enhanced Signing Experience for All Users

From internal teams to external collaborators, MSB Docs ensures a seamless signing experience for everyone involved in the process.

User-Centric Features:

• Mobile-Optimized Signing: Sign documents from any device, ensuring flexibility for on-the-go researchers and stakeholders.
• Customizable Signing Options: Includes biometric signatures, Aadhar-based signing, qualified electronic signatures, and digital certificates for added flexibility.
• Auto-Account Creation for External Users: Simplifies the process for external signers, such as patients and clinical trial participants.

5. Comprehensive Audit Trails and Reporting

Regulatory audits are inevitable in the life sciences industry, making detailed documentation a necessity. MSB Docs provides comprehensive audit trails and reporting tools that simplify compliance.

Audit-Ready Features:

• Certificate of Completion: Automatically generated and tamper-proof, providing a complete history of the signing process.
• Activity Logs: Detailed records of all user actions, including timestamps and IP addresses, to ensure transparency.
• Custom Reporting: Advanced reporting tools enable organizations to monitor compliance metrics in real time.

Real-Life Scenario:

When facing a regulatory audit, not having a clear record of every action taken on a document can result in delays and potential non-compliance penalties. MSB Docs’ audit trail feature ensures that you can trace every signer action, providing you with a comprehensive and tamper-proof report to stay audit-ready at all times.

6. Quality Assurance That You Can Trust

MSB Docs’ commitment to quality is unparalleled, with rigorous testing and validation processes designed to meet industry standards.

Quality Highlights:

• Automated & Manual Testing: Ensures all features meet operational and performance qualifications.
• Validation Documentation: Includes IQ, OQ, FQ, and PQ test plans, scripts, and results with objective evidence.
• Regular Updates: Ongoing improvements ensure the platform evolves with changing regulatory requirements.

Real-Life Scenario:

With MSB Docs, life sciences organizations can trust that their eSignature solution is always up to standard, with automated testing and regular updates to meet the most demanding regulatory needs.

What sets MSB Docs apart is its built-in validation package, which saves companies thousands of dollars and months of effort. Unlike other eSign solutions, which require additional costs for third-party validation, MSB Docs comes pre-validated, making adoption seamless. This means companies can expedite their User Acceptance Testing (UAT) and onboard quickly, significantly reducing time-to-value.

For instance, a pharmaceutical company recently adopted MSB Docs for managing its global trials and reported saving both substantial time and money by eliminating the need for third-party validation. With MSB Docs, they streamlined their processes and focused on what matters most—advancing their research.

MSB Docs isn’t just an eSignature solution; it’s a smarter way to scale clinical operations.

7. Global Recognition and Proven Success

MSB Docs is trusted by some of the world’s leading life sciences organizations, including Pfizer, Glenmark, and ICON, to deliver compliant and efficient eSignature solutions.

One of the top Pharma companies:

Accelerated Clinical Trials

They leveraged MSB Docs to streamline its eSignature workflows, achieving:

• 88% reduction in document errors for clinical trial agreements.
• 6x ROI through workflow automation.
• Document turnaround times reduced from 13 days to just 3 days.

“By reducing document turnaround times from 13 days to just 3, they not only accelerated clinical trials but also brought potentially life-saving medications closer to patients in need.” – ICON

Ensured Global Compliance

They adopted MSB Docs to enhance regulatory processes, resulting in:

• Zero GDP errors, ensuring flawless compliance with GxP standards.
• Huge savings through automated document distribution.
• Reduction of manual steps from 36 to just 6 automated processes.

“The integration with MSB has completely transformed the day-to-day work at Pfizer. We have used the platform for our corporate credentials and SAFETM, where paper-based signatures are now seamlessly replaced by digital signatures. This has helped us in streamlining the approval and management of electronic laboratory notebooks, regulated electronic documents submission and management of confidential software development documents.”
– George S. Rathbun– Director, Worldwide Technology Engineering, Pfizer

Experience the MSB Docs Advantage

MSB Docs has been at the forefront of innovation in the life sciences industry for over a decade, delivering trusted eSignature solutions designed to meet the most stringent compliance standards. With a focus on 21 CFR Part 11, robust security, and seamless automation, MSB Docs empowers organizations to reduce risks, save time, and focus on advancing life-saving innovations.

Ready to simplify compliance with 21 CFR Part 11?

Contact MSB Docs today to explore how our eSignature solution can transform your workflows and drive success.