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Implementing Digital Signatures in an FDA-Regulated Environment


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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

Published in: Technology
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Implementing Digital Signatures in an FDA-Regulated Environment

  1. 1. Implementing Digital Signatures in anFDA-Regulated EnvironmentMichelle Engler, Senior Application Architect, Life Sciences, Perficientwith support from Sally Miranker, Computer System Validation, Life Sciences, PerficientTina Howard, Quality Assurance-Compliance, Life Sciences, Perficient
  2. 2. 2 Perficient is a leading information technology consulting firm serving clients throughoutNorth America and Europe. We help clients implement business-driven technology solutions that integrate business processes, improve worker productivity, increase customer loyalty and create a more agile enterprise to better respond to new business opportunities. About Perficient
  3. 3. 3 •Founded in 1997 •Public, NASDAQ: PRFT •2013 revenue $373 million •Major market locations: •Allentown, Atlanta, Boston, Charlotte, Chicago, Cincinnati, Columbus, Dallas, Denver, Detroit, Fairfax, Houston, Indianapolis, Minneapolis, New York City, Northern California, Oxford (UK), Philadelphia, Southern California, St. Louis, Toronto, Washington, D.C. •Global delivery centers in China and India •>2,200 colleagues •Dedicated solution practices •~90% repeat business rate •Alliance partnerships with major technology vendors •Multiple vendor/industry technology and growth awards Perficient Profile
  4. 4. Business Process Management Customer Relationship Management Enterprise Performance Management Enterprise Information Solutions Enterprise Resource Planning Experience Design Portal / Collaboration Content Management Information Management Mobile BUSINESS SOLUTIONS 50+ PARTNERS Safety / PV Clinical Data Management Electronic Data Capture Medical Coding Clinical Data Warehousing Clinical Data Analytics Clinical Trial Management Healthcare Data Warehousing Healthcare Analytics CLINICAL / HEALTHCARE IT Consulting Implementation Integration Migration Upgrade Managed Services Private Cloud Hosting Validation Study Setup Project Management Application Development Software Licensing Application Support Staff Augmentation Training SERVICES
  5. 5. 5 Michelle Engler, Senior Solutions Architect Life Sciences, Perficient (650) 291-4710 Sally Miranker, Head of Computer Systems Validation Life Sciences, Perficient (619) 980-7288 Tina Howard, Head of Quality Assurance Compliance Life Sciences, Perficient (760) 696-3650 Welcome & Introduction
  6. 6. Agenda •Digital Signature Technology Overview •Requirements for a dSignatureSolution •Available dSignatureSolutions •dSignatureSolution and 21 CFR Part 11 Compliance •Implementing, Validating, and Releasing the dSignatureSolution •Demonstration •Future Plans •Questions •Contact Information 6
  7. 7. Digital Signature Technology Overview Electronic Signatures and Digital Signatures •Definitions FDA 21 CFR 11.3 (7) -Electronic Signature The term 'electronic signature' means an electronic sound, symbol, or process, attached to or logically associated with a contract or other record and executed or adopted by a person with the intent to sign the record •FDA 21 CFR 11.3 (5) -Digital Signature Digital signature means an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified A digital signature falls into a sub-group of electronic signatures that provides the highest levels of security and universal acceptance. Digital signatures are based on Public Key Infrastructure (PKI) technology, and guarantee signer identity and intent, data integrity, and the non-repudiation of signed documents.1 1. 7
  8. 8. Digital Signature Technology Overview What is a digital signature? •Adigital signaturetakes the concept of traditional paper-based signing and turns it into an electronic “fingerprint.” This “fingerprint,” or coded message, is unique to both the document and the signer and binds them together. •Digital signatures ensure the authenticity of the signer. •Any changes made to the document after it has been signed invalidate the signature, thereby protecting against signature forgery and information tampering. Is a digital signature legally enforceable? •Yes. In 1999, the EU passed the “EU Directive for Electronic Signatures” and on June 30, 2000, President Clinton signed the Electronic Signatures in Global and National Commerce Act (“ESIGN”), which made signed electronic contracts and documents as legally binding as a paper-based contract. Today, digital signature (standard electronic signature) solutions carry recognized legal significance, enabling organizations to comply with regulations worldwide. 8
  9. 9. Business Case for Digital Signatures - Survey Compliance and Assumptions 9 •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
  10. 10. Business Case for Digital Signatures - Department Signatures Per Month 10
  11. 11. Business Case for Digital Signatures – Types of Documents 11
  12. 12. Perficient-Life Sciences Requirementsfor a Digital Signature Solution 12 •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 basedoncontrol of the environment
  13. 13. Digital Signature SolutionsResearched and Reviewed 13 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
  14. 14. Digital Signature Solution – Selection of ARX CoSign •ARX CoSignSelected –Client based installation with installed, unconfiguredappliance 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 14
  15. 15. ARX CoSignand 21 CFR Part 11 (1 of 3) 15
  16. 16. ARX CoSignand 21 CFR Part 11 (2 of 3) 16
  17. 17. ARX CoSignand 21 CFR Part 11 (3 of 3) 17
  18. 18. 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 18
  19. 19. Implementing and Validating the Digital Signature Solution (continued) •Create Supplemental Guidelines and Guides –CoSignClient User Guideline –CoSignWeb Application User Guideline –CoSignAdministrator Guide •Create New Application Roles –CoSignSuper User Role –CoSignUser Role •Create Training Materials –CoSignOverview –Training on CoSignClient (video and presentation) –Training on CoSignWeb 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 19
  20. 20. 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 20
  21. 21. Future Plans •Use ARX CoSign MS Word “Sectional Signing” to allow completion of test cases electronically •Create a connector between ARX CoSignand the Perficient-LS EDMS, Alfresco Community Edition •Provide implementation and validation services for Life Sciences companies wishing to implement ARX CoSign 21
  22. 22. Demonstration 22
  23. 23. 23
  24. 24. Thank You! For more information, please contact: (Sales) +44 (0) 1865 910200 (U.K. Sales) +1 303 570 8464 (U.S. Sales)