Implementing Digital Signatures in an FDA-Regulated Environment Michelle Engler, Senior Application Architect, Life Sciences, Perficient with support from Sally Miranker, Computer System Validation, Life Sciences, Perficient Tina Howard, Quality Assurance-Compliance, Life Sciences, Perficient facebook.com/perficient twitter.com/Perficient_LS linkedin.com/company/perficient
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Implementing Digital Signatures in an FDA-Regulated Environment
Perficient’s life sciences practice once had a manual, time-consuming and expensive process for signing and collecting validation documents. From handwritten signatures to scanning and shipping documents all over the globe, it was only a matter of time before we made the move to 21 CFR Part 11-compliant digital signatures.
Michelle Engler, an expert in the development of clinical applications, discussed our experience implementing a digital signature solution and how your organization can benefit from one too.
During the presentation, we will covered:
-Cost-benefit analysis -Solution selection and implementation -21 CFR Part 11 system validation -Lessons learned
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Transcript
Implementing Digital Signatures in an
FDA-Regulated Environment
Michelle Engler, Senior Application Architect, Life Sciences, Perficient
with support from
Sally Miranker, Computer System Validation, Life Sciences, Perficient
Tina Howard, Quality Assurance-Compliance, Life Sciences, Perficient
enabling organizations to comply with regulations worldwide.
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Business Case for Digital Signatures -
Survey Compliance and Assumptions
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• Survey Monkey was utilized to create a survey to assess the business need and
results were able to be compiled from 53 respondents
• Perficient-Life Sciences processes approximately 856 signatures for the 53
• Time to print, sign, scan, upload, and mail original document to headquarters for
each signatory was estimated and calculated company-wide
• Time to execute a digital signature was estimated at 5 minutes per signature
• Anticipated time/resource savings is approximately 75% or 314 hours/month
Unaccounted for variables: signer’s location (for mailing), equipment limitations, cost
of materials (e.g. paper, printer ink), and management of hard copies of documents
Business Case for Digital Signatures -
Department Signatures Per Month
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Business Case for Digital Signatures –
Types of Documents
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Perficient-Life Sciences Requirements
for a Digital Signature Solution
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• Support third-party Applications (Word, Excel, PDF)
• Allow for multiple signatures per document
• Allows for sectional signing (MS Word)
• Has audit trail and secured time stamps
• Allows for sequential and parallel signing workflow
• Receives instant alerts when someone signs
• Integrates with our EDMS (Alfresco)*
• Compliant with 21 CFR Part 11
• Integrates with Active Directory and requires username/password for signing
• Provides phone/email support
• System is easy and intuitive to use
• System has trial period
• System is available in the cloud**
* No solutions were able to integrate directly out-of-the-box with our Alfresco environment; hence, this requirement was adjusted to require the ability to integrate systems via a development API
** Later, we determined that having a system in the cloud introduced more risk than having a local installation of the solution based oncontrol of the environment
Digital Signature Solutions
Researched and Reviewed
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DocuSign*
• Cloud-based only
• Cost determined on number of signatures executed
• Extensive full routing and signing certificates
available
• Utilized in many other industries
• Several configuration options available
• Only signs PDF
• Adequate support available
• Electronic Signatures
• Full Web API for EDMS integration available
AssureSign*
• Client or cloud-based solution available
• Cost determined by number of signers
• Full routing available
• Uses templates for signing
• Only signs PDFs
• Adequate support available
• Digital Signatures
• Full Web API for EDM Integration available
Signadura*
• Least expensive solution
• Not fully translated to English
• Support was provided from Spain
• Only signs PDFs
• Digital Signatures
• Integrated with Alfresco
ARX CoSign*
• Client or cloud-based solution available
• Cost determined by number of signers
• Routing available when integrated with EDMS
• Signs PDFs, MS Word, or MS Excel documents
• Experienced with Life Sciences and 21 CFR Part 11 Compliance
• Cost was competitive with other solutions
• Adequate support available
• Digital Signatures
• Full Web API for EDMS integration available
Adobe EchoSign
• Most expensive solution available
• Ruled out based on existence of lower cost options
* Demonstration completed by vendor for solution
Digital Signature Solution –
Selection of ARX CoSign
• ARX CoSign Selected
– Client based installation with installed, unconfigured appliance
provided by ARX
– Allows for signing of all types of documents
– Integration with SharePoint available and full Web Developers API
available
– Provides for client software or signing via a web browser
– Allows prepping of documents for signature
– Adequate support available and provided
– Cost-effective solution that provides Perficient-Life Sciences
employees/consultants with the ability to sign documents
– Opportunity for Perficient–Life Sciences to become an
implementation expert for digital signature solutions for our clients
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ARX CoSign and 21 CFR Part 11 (1 of 3)
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ARX CoSign and 21 CFR Part 11 (2 of 3)
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ARX CoSign and 21 CFR Part 11 (3 of 3)
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Implementing and Validating the Digital
Signature Solution
• Receive, install, and configure CoSign Appliance
• Install and configure CoSign Web Application (separate web server)
• Add CoSign User and Administrator Groups to Active Directory
• Determine how the system can be used for existing documents
– Updated signature block of document templates
– Meaning of signature added to signature block of document templates
• Prepare and execute full validation for the system:
– Validation Plan
– User Requirements Specification (URS)
– User Requirements to Performance Qualification Traceability Matrix
– Installation Qualification (IQ) Protocol
– Installation Log
– IQ Test Suite
– IQ Summary Report
– Performance Qualification (PQ) Protocol
– PQ Test Suite
– PQ Summary Report
– Validation Summary Report with Statement of Validation
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Implementing and Validating the Digital
Signature Solution (continued)
• Create Supplemental Guidelines and Guides
– CoSign Client User Guideline
– CoSign Web Application User Guideline
– CoSign Administrator Guide
• Create New Application Roles
– CoSign Super User Role
– CoSign User Role
• Create Training Materials
– CoSign Overview
– Training on CoSign Client (video and presentation)
– Training on CoSign Web Application (video and presentation)
• Update existing SOP-001 Controlled Documents procedure to allow for
digital signatures
• Send letter of non-repudiation to FDA to inform them of our use of digital
signatures
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Releasing the Digital Signature Solution
• Perficient-Life Sciences Support Representative trained on Tier 1 support
• Internal bug tracking system updated to accept issues/questions with the
implementation of CoSign
• Controlled Document Required Training Notification sent
• Supplemental training provided as video, live session, and with
presentations
• Rolling release implemented for users that have completed required
training
• Installation support provided to those users that have completed training
and require the CoSign Client
• Solution Released in August 2014
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Future Plans
• Use ARX CoSign MS Word “Sectional Signing” to allow completion of
test cases electronically
• Create a connector between ARX CoSign and the Perficient-LS EDMS,
Alfresco Community Edition
• Provide implementation and validation services for Life Sciences