Sponsor Site Questionnaire FAQs Regarding Maestro Care
|
|
- Aubrie Mitchell
- 8 years ago
- Views:
Transcription
1 Sponsor Site Questionnaire FAQs Regarding Maestro Care Data Security and Validation 1. Are the electronic source documents or computer systems specific to the site and/or developed by the site? a. Developed by Epic 2. Is the computer system Internet Based? 3. Does the computer system use a Local Area Network? 4. What is the primary use of the computer system? a. Electronic Medical Records System (EMR) b. Lab Information System (ECG, Xray, Etc.) 5. Are there procedures and/or manuals available at the site that describe: a. how to install and maintain the system: No (see below) b. how to validate a system: No (see below) c. how to operate and use the system: Yes d. how to back up the data in the system and, if necessary, recover the data: Yes e. how users of the system are trained: Yes f. alternative methods for recording the information normally gathered by the system (in case of system unavailability): Yes (see below) g. how data in the system will be archived or otherwise retained after the study is completed: Yes Epic is a network-based application, so sites do not install anything locally. Everything is installed, tested, and maintained by the Maestro Care team, and they maintain the necessary documentation for this. There are downtime procedures for each Duke site to follow in case of system or network unavailability. 6. Is this system validated? (i.e. Is there documentation available to verify that the system was installed correctly and all functions to be used for the study have been tested to ensure they accurately, reliably and consistently perform as intended?), In terms of validation of our Epic environment, there is an extensive testing process that was employed before go-live, and would also be used prior to any major changes to the system, to validate its functionality. This process was built on best practices provided by Epic, but also included test cases built by Duke for our environment. Documentation regarding these procedures and the results is maintained by the MaestroCare team. It should be noted that while this testing is extensive, we are not making any claims that our testing would be in line with FDA 21 CFR Part 11 compliance requirements. 7. Is the computer system validated under 21 CFR Part 11? a. No, Duke s Medicine s Epic EMR system is not validated under 21 CFR Part 11. However, we maintain compliance with HIPAA and consider electronic signatures within the Epic system to be legally binding
2 8. Is the computer hardware kept in a secure location?, all of Duke s Epic servers are located in secured data center facilities 9. Is the location of the data physically secure (for example, computer server and data tapes in locked room)? 10. Dose the computer system have a virus detection/protection program?, Anti-malware protection software is employed on all systems that are commonly affected by malware. 11. How are modifications/system enhancements handled? a. We have a change management process to document the promotion of system changes from development through test and production environments. Changes are reviewed by a Change Advisory Board before being allowed to proceed. 12. In the event of power outage, is there a power backup available? 13. Is the data in the system backed up on a regular basis? Please comment as to how frequently this occurs. Are back-ups maintained in a secure location?, backed up daily and maintained in a secure location 14. Is there a process for backing up the data in the system?, There is a nightly data backup 15. Is the data backup sent offsite? a. No 16. Is there a process for restoring data from backup media? 17. In the case of system failure, what back-up procedures are available and how are they accessible? a. The production Epic environment is shadowed in near-real time to a recovery system that allows quick failover in the case of system downtime. Epic's Business Continuity Access (BCA) devices are also deployed to allow for local access at clinic locations in the case of network downtime. 18. Is there a procedure that describes how data backups are made and kept? Does this procedure address disaster recovery? 19. Is there a procedure that describes electronic record retention? a. Epic uses an enterprise-wide data repository that requires no data archiving or purging of electronic records from the system. This configuration ensures that complete electronic patient records are immediately available to authorized users.
3 20. Are the electronic records archived in accordance to local regulations for clinical studies or patient records, whichever is longer? a. Epic uses an enterprise-wide data repository that requires no data archiving or purging of electronic records from the system. This configuration ensures that complete electronic patient records are immediately available to authorized users. 21. Is there periodic testing to ensure continued functionality of all validated processes? a. Our Maestro Care environment has an extensive testing and change management process to verify correct operation of the system, but we need to be careful about the use of the word "validation" as that might imply that we meet 21 CFR Part 11's validation procedures, which we don't. 22. Does the audit trail indicate the reason a change was made, if the reason is not obvious? a. We have formal change management processes that include documentation and approval of all changes. 23. Does the site have SOPs regarding system and process management of EMR systems (i.e., system maintenance, security requirements, training, back-up, etc.)?. 24. Is there a plan on how to continue with business in the event of a system failure?. User Access and Electronic Signatures 25. Are procedures in place for use of the computer system? 26. Does the EMR system have a User Manual?, Epic provides extensive documentation for the system. In addition, Duke develops custom documentation as-needed for localized features or functions. 27. Are users trained on how to operate the computer system? a. All users are required to complete a customized training curriculum before being provided access to Duke's Epic environment. 28. Is the user training documented? 29. Are unique user IDs and passwords required to access the system? a. Unique User IDs and passwords are maintained through Duke's enterprise-wide identity management system, which provides automated mechanisms to limit access to Duke systems based on an individual's affiliation with Duke as a faculty, staff, or student, or as a sponsored guest. 30. Is each individual s user ID unique and never reassigned to a different individual? 31. Are individual users required to periodically change their password and not share it with other individuals?
4 32. How many log-in attempts are allowed before it locks the user s account? a. Three 33. Does the system automatically log off the user after idle periods? 34. Is there a procedure that describes how User IDs and passwords will be maintained? a. Unique User IDs and passwords are maintained through Duke's enterprise-wide identity management system, which provides automated mechanisms to limit access to Duke systems based on an individual's affiliation with Duke as a faculty, staff, or student, or as a sponsored guest. In addition, access to Duke's Epic EHR environment is provided only to those who have a legitimate need, and there are automated tools in place to manage the process for authorizing these requests. Password policy requirements (e.g. complexity, aging, lock-out, and re-use restrictions) are implemented through Active Directory. 35. Is there a procedure that describes System Administration access vs. User access? a. Epic s multi-leveled role-based security architecture allows you to determine each user s type and level of access. Access to specific operations is granted through a user s specific configuration of User Role, User Security Classifications, and Profile settings: User Role assignments determine what buttons and menu bar options are available to users. Each role is also associated with a timeout action and number of minutes the system can be left inactive before it logs the user out or secures the session. Security Classifications determine whether a user can access specific menus, functions and features. A dietician, for example, would not need to see all of the features and information that a nurse or physician would. Dieticians are able to work more quickly and efficiently seeing only the features and information they need. You can assign users separate Security Classifications that correspond with each area where the users work. Profiles determine which content appears to a member or members of a functional role. For example, a Profile setting determines which Patient Summary reports are available to a user, assuming they have security to see Patient Summary reports at all. Profiles can be assigned to individual users, department and unit workstations, or Security Classifications. 36. Is a log kept and maintained under change control detailing who has system access and what level of access (for example, System Administrator, User, Read Only)? 37. Will the Monitor have access to the electronic health records?, through the Release to Inspector report 38. Will the Monitor for the clinical trial be issued read-only access with a password to access the electronic data for subjects participating in the clinical trial? 39. Does your institution require the Monitor to complete a site-specific access request form and/or complete an online course before accessing the system? a. No, the study team will request access for the monitor through Health Information Management (HIM) and an online course is not required for monitors
5 40. Is the clinical investigator able to ensure accurate and complete electronic and printed readable copies of electronic records, suitable for review and copying? a. Clinical investigator can ensure accurate and complete electronic records. However, these may not be printed or copied for Monitor use without de-identification 41. Will a monitor, auditor, or inspector be able to directly access the information for the study that is in the system? (e.g. Will the monitor be given an unique User ID and password to be able to log into and view data within the system?), they will be provided with a PDF Release to Inspector report 42. Are there restrictions that prevent Monitor access to identifiable personal information for patients not involved in this study? 43. Do you use electronic signatures?, All electronic signatures executed by Duke employees, agents or representatives, located anywhere in the world, are the legally binding equivalent of traditional handwritten signatures. Additionally, examples of actions that the System automatically date-, time-, and user-stamps include: 44. If you are using electronic signatures, does it have the following? User ID, password, date stamp, time stamp, the meaning associated with the signature (for example, review, approval, responsibility and/or authorship, etc.)., examples of actions that the System automatically date-, time-, and user-stamps include:
6 45. When an electronic signature is used does the electronic record display the full printed name of the signer? 46. Does the record contain the date and time the electronic signature was executed? 47. Does the record contain the meaning (e.g. review, approval, responsibility, authorship) of the electronic signature?, examples of actions that the System automatically date-, time-, and user-stamps include: 48. Does the signer s name, and the date, time, and meaning of every electronic signature appear on every display or printout of the signed record? 49. Does the system require the use of all components (i.e. user ID and password) for the first signature in a signing session? 50. Are there any changes planned to the system which may affect access or the method in which source data is recorded? a. No 51. After the trial is closed, are e-records available for access during the records retention period? 52. Can archived electronic medical records be retrieved for a regulatory inspection after the study is closed? 53. In regards to electronic signatures: a. Is the electronic signature protected from intentional or unintentional miss-use? b. Is the electronic signature protected from cutting and pasting to other records? c. Is the electronic signature made invalid when a signed record is altered? i. The answer to the above questions is yes. 54.
7 Audit Trail 55. Is there an audit trail in the system to capture changes to data? If yes, does the system keep a record of all data captured and all changes made to this data? Does the change contain the following items in the audit trail? User name/id of who authored the change, date stamp, time stamp, reason for change, original data is accessible within the history of the change., Epic s clinical applications capture an extensive audit trail that includes the user ID, date and time of access, and contact record accessed. Examples of actions that the EpicCare Enterprise Clinical System automatically date-, time-, and user-stamps include: 56. Can the audit trail be printed out? 57. Does the audit trail record the identity of the operator, the date and time of the operation, and the previously recorded information (if any)? 58. Is the audit trail switched on from the point of data entry? 59. Can the audit trail be edited? a. No
Tools to Aid in 21 CFR Part 11 Compliance with EZChrom Elite Chromatography Data System. White Paper. By Frank Tontala
Tools to Aid in 21 CFR Part 11 Compliance with EZChrom Elite Chromatography Data System White Paper By Frank Tontala Agilent Technologies Software & Informatics Life Sciences & Chemical Analysis Group
More informationEmpower TM 2 Software
Empower TM 2 Software 21 CFR PART 11 COMPLIANCE ASSESSMENT Revision A, December, 2005 1 of 14 Waters Corporation Note: Information presented in this document assumes that the appropriate Empower 2 System
More informationREGULATIONS COMPLIANCE ASSESSMENT
ALIX is free software: you can redistribute it and/or modify it under the terms of the GNU General Public License as published by the Free Software Foundation. REGULATIONS COMPLIANCE ASSESSMENT BUSINESS
More informationNova Southeastern University Standard Operating Procedure for GCP. Title: Electronic Source Documents for Clinical Research Study Version # 1
Nova Southeastern University Standard Operating Procedure for GCP Title: Electronic Source Documents for Clinical Research Study Version # 1 SOP Number: OCR-RDM-006 Effective Date: August 2013 Page 1 of
More informationFull Compliance Contents
Full Compliance for and EU Annex 11 With the regulation support of Contents 1. Introduction 2 2. The regulations 2 3. FDA 3 Subpart B Electronic records 3 Subpart C Electronic Signatures 9 4. EU GMP Annex
More informationCoSign for 21CFR Part 11 Compliance
CoSign for 21CFR Part 11 Compliance 2 Electronic Signatures at Company XYZ Company XYZ operates in a regulated environment and is subject to compliance with numerous US government regulations governed
More information21 CFR Part 11 Compliance Using STATISTICA
21 CFR Part 11 Compliance Using STATISTICA Last Updated: April 2003 This document was updated to reflect the FDA s latest guidance (released February, 2003) and the withdrawal of previous guidance.! STATSOFT
More informationGuidance for Industry Computerized Systems Used in Clinical Investigations
Guidance for Industry Computerized Systems Used in Clinical Investigations U.S. Department of Health and Human Services Food and Drug Administration (FDA) Office of the Commissioner (OC) May 2007 Guidance
More informationOracle WebCenter Content
Oracle WebCenter Content 21 CFR Part 11 Certification Kim Hutchings US Data Management Phone: 888-231-0816 Email: khutchings@usdatamanagement.com Introduction In May 2011, US Data Management (USDM) was
More informationAgilent MicroLab Software with Spectroscopy Configuration Manager and Spectroscopy Database Administrator (SCM/SDA)
Agilent MicroLab Software with Spectroscopy Configuration Manager and Spectroscopy Database Administrator (SCM/SDA) Compliance with 21 CFR Part 11 Introduction Part 11 in Title 21 of the Code of Federal
More informationFILEHOLD DOCUMENT MANAGEMENT SYSTEM 21 CFR PART 11 COMPLIANCE WHITE PAPER
FILEHOLD DOCUMENT MANAGEMENT SYSTEM 21 CFR PART 11 COMPLIANCE WHITE PAPER Copyright 2012 FileHold Systems Inc. All rights reserved. For further information about this manual or other FileHold Systems products,
More informationDeltaV Capabilities for Electronic Records Management
January 2013 Page 1 DeltaV Capabilities for Electronic Records Management This paper describes DeltaV s integrated solution for meeting FDA 21CFR Part 11 requirements in process automation applications
More informationInfoCenter Suite and the FDA s 21 CFR part 11 Electronic Records; Electronic Signatures
InfoCenter Suite and the FDA s 21 CFR part 11 Electronic Records; Electronic Signatures Overview One of the most popular applications of InfoCenter Suite is to help FDA regulated companies comply with
More informationCompliance Response Edition 07/2009. SIMATIC WinCC V7.0 Compliance Response Electronic Records / Electronic Signatures. simatic wincc DOKUMENTATION
Compliance Response Edition 07/2009 SIMATIC WinCC V7.0 Compliance Response Electronic Records / Electronic Signatures simatic wincc DOKUMENTATION Compliance Response Electronic Records / Electronic Signatures
More informationDeltaV Capabilities for Electronic Records Management
September 2004 Page 1 An integrated solution for meeting FDA 21CFR Part 11 requirements in process automation applications using a configurable off-the-shelf (COTS) solution Emerson Process Management.
More informationAutoSave. Achieving Part 11 Compliance. A White Paper
AutoSave Achieving Part 11 Compliance A White Paper Synopsis This whitepaper provides information related to FDA regulation 21 CFR Part 11 (Part 11) for organizations considering MDT software solutions.
More informationImplementing Title 21 CFR Part 11 (Electronic Records ; Electronic Signatures) in Manufacturing Presented by: Steve Malyszko, P.E.
Implementing Title 21 CFR Part 11 (Electronic Records ; Electronic Signatures) in Manufacturing Presented by: Steve Malyszko, P.E. President & CEO Agenda Introduction Who is Malisko Engineering? Title
More informationSelf-Assessment of eresearch Compliance with 21 CFR Part 11, Electronic Record; Electronic Signatures
Self-Assessment of eresearch Compliance with 21 CFR Part 11, Electronic Record; Electronic Signatures Subpart A General Provisions Sec. 11.1 Scope. (a) The regulations in this part set forth the criteria
More informationManual 074 Electronic Records and Electronic Signatures 1. Purpose
1. Purpose The purpose of this document is to provide an interpretation of FDA 21 CFR Part 11, Electronic Records; Electronic Signatures (ER/ES) and to provide guidance for acceptable practices in the
More informationInfinityQS SPC Quality System & FDA s 21 CFR Part 11 Requirements
InfinityQS SPC Quality System & FDA s 21 CFR Part 11 Requirements www.infinityqs.com Copyright InfinityQS International Table of Contents Overview... FDA s 21 CFR Part 11 Requirements... PART 11 ELECTRONIC
More informationThermal Analysis. http://www.fda.gov. Subpart A General Provisions 11.1 Scope. 11.2 Implementation. 11.3 Definitions.
Thermal Analysis 21 CFR 11 Compliance 21 CFR Part 11 Electronic Records; Electronic Signatures General concept The U.S. Federal Food and Drug Administration (FDA) has issued regulations that provide criteria
More informationSolidWorks Enterprise PDM and FDA 21CFR Part 11
T E C H N I C A L P A P E R SolidWorks Enterprise PDM and FDA 21CFR Part 11 This Technical Paper discusses the technical solutions provided by SolidWorks Enterprise PDM to address the FDA 21 CFR Part 11
More informationCompliance in the BioPharma Industry. White Paper v1.0
in the BioPharma Industry White Paper v1.0 July 2005 I. Introduction...3 II. Overview of Regulations...3 III. Overview of Validation...4 a. Validation...4 b. Security s Part Within Validation...6 IV. Introduction
More informationElectronic records and electronic signatures in the regulated environment of the pharmaceutical and medical device industries
White Paper No 01 I December 2010 Implementation of 21 CFR Part 11 in the epmotion Software Electronic records and electronic signatures in the regulated environment of the pharmaceutical and medical device
More information21 CFR Part 11 Electronic Records & Signatures
Gap Analysis - Checklist 21 CFR Part 11 Electronic Records & Signatures his document is a proposal and starting point only. he type and extent of documentation depends on the process environment. he proposed
More information21 CFR Part 11 Checklist
21 CFR Part 11 Checklist GUIDE NOTOCORD - 113 Chemin de Ronde - 78290 Croissy-sur-Seine www.notocord.com my.notocord.com support@notocord.com +33 (0)1 34 80 00 00 1. Preliminary information 1.1. Purpose
More informationSignature Authentication
Signature Authentication aka: How to stop chasing after your clinical staff for signatures Elizabeth Nista, CQIA The Written Signature as a Validation Tool Signature is a requirement of multiple accrediting
More informationPOLICY ISSUES IN E-COMMERCE APPLICATIONS: ELECTRONIC RECORD AND SIGNATURE COMPLIANCE FDA 21 CFR 11 ALPHATRUST PRONTO ENTERPRISE PLATFORM
W H I T E P A P E R POLICY ISSUES IN E-COMMERCE APPLICATIONS: ELECTRONIC RECORD AND SIGNATURE COMPLIANCE FDA 21 CFR 11 ALPHATRUST PRONTO ENTERPRISE PLATFORM This white paper is written for senior executives
More informationHow To Write A Health Care Security Rule For A University
INTRODUCTION HIPAA Security Rule Safeguards Recommended Standards Developed by: USF HIPAA Security Team May 12, 2005 The Health Insurance Portability and Accountability Act (HIPAA) Security Rule, as a
More informationCompliance Matrix for 21 CFR Part 11: Electronic Records
Compliance Matrix for 21 CFR Part 11: Electronic Records Philip E. Plantz, PhD, Applications Manager David Kremer, Senior Software Engineer Application Note SL-AN-27 Revision A Provided By: Microtrac,
More informationDeclaration of Conformity 21 CFR Part 11 SIMATIC WinCC flexible 2007
Declaration of Conformity 21 CFR Part 11 SIMATIC WinCC flexible 2007 SIEMENS AG Industry Sector Industry Automation D-76181 Karlsruhe, Federal Republic of Germany E-mail: pharma.aud@siemens.com Fax: +49
More informationComputerized Systems Used in Medical Device Clinical Investigations
Computerized Systems Used in Medical Device Clinical Investigations Presented by Jonathan Helfgott Consumer Safety Officer Division of Bioresearch Monitoring Office of Compliance Center for Devices and
More informationFDA Title 21 CFR Part 11:Electronic Records; Electronic Signatures; Final Rule (1997)
www.qadata.co.za Introduction FDA Title 21 CFR Part 11:Electronic Records; Electronic Signatures; Final Rule (1997) INITIAL REGULATION RELEASED High profile audit findings Industry complaints to wasting
More informationIntland s Medical Template
Intland s Medical Template Traceability Browser Risk Management & FMEA Medical Wiki Supports compliance with IEC 62304, FDA Title 21 CFR Part 11, ISO 14971, IEC 60601 and more INTLAND codebeamer ALM is
More informationSpectroscopy Configuration Manager (SCM) Software. 21 CFR Part 11 Compliance Booklet
Spectroscopy Configuration Manager (SCM) Software 21 CFR Part 11 Compliance Booklet Notices Agilent Technologies, Inc. 2015 No part of this manual may be reproduced in any form or by any means (including
More informationUsing Chromeleon Chromatography Management Software to Comply with 21 CFR Part 11
Technical Note 54 Using Chromeleon Chromatography Management Software to Comply with 21 CFR Part 11 The Electronic Records and Signatures Rule 1, known as 21 CFR Part 11, was established by the U.S. Food
More informationOverview. Disasters are happening more frequently and Recovery is taking on a different perspective.
Overview Disasters are happening more frequently and Recovery is taking on a different perspective. Defining a Disaster/Disaster Recovery Basic requirements in preparing for a disaster The role of Quality
More informationrsdm and 21 CFR Part 11
rsdm and 21 CFR Part 11 Meeting the 21 CFR Part 11 Burden without Overburdening The right solutions for smaller biopharma. Nothing more. Nothing less. Prepared by: Ken VanLuvanee www.virtualregulatorysolutions.com
More information21 CFR PART 11 ELECTRONIC RECORDS, ELECTRONIC SIGNATURES 21.11.2013. 21 CFR Part 11 Compliance PLA 2.1
21 CFR PART 11 ELECTRONIC RECORDS, ELECTRONIC SIGNATURES Compliance of PLA 2.1 21.11.2013 21 CFR Part 11 Compliance PLA 2.1 SEC. 11.2 IMPLEMENTATION. (a) For records required to be maintained but not submitted
More informationEclipsys Sunrise Clinical Manager Enterprise Electronic Medical Record (SCM) and Title 21 Code of Federal Regulations Part 11 (21CFR11)
Eclipsys Sunrise Clinical Manager Enterprise Electronic Medical Record (SCM) and Title 21 Code of Federal Regulations Part 11 (21CFR11) The title 21 code of federal regulations part 11 deals with an institutions
More information21 CFR Part 11 Implementation Spectrum ES
21 CFR Part 11 Implementation Spectrum ES INFRARED SPECTROSCOPY T E C H N I C A L N O T E Introduction Compliance with 21 CFR Part 11 is mandatory for pharmaceutical companies and their suppliers to sell
More informationLabChip GX/GXII with LabChip GxP Software
Regulatory Compliance LabChip GX/GXII with LabChip GxP Software Supporting Regulatory Compliance Caliper LabChip GX/GXII suite of instruments provides automated electrophoresis to analyze quality, size,
More informationScreenMaster RVG200 Paperless recorder FDA-approved record keeping. Measurement made easy
Information INF13/147 EN ScreenMaster RVG200 Paperless recorder FDA-approved record keeping Measurement made easy Guidance on the use of the RVG200 paperless recorder for electronic record keeping in FDA-approved
More informationHow To Secure An Emr-Link System Architecture
EMR-Link Security Administration Guide Introduction This guide provides an overview of the security measures built into EMR-Link, and how your organization s security policies can be implemented with these
More informationMeeting the FDA s Requirements for Electronic Records and Electronic Signatures (21 CFR Part 11)
Meeting the FDA s Requirements for Electronic Records and Electronic Signatures (21 CFR Part 11) Executive Summary...3 Background...4 Internet Growth in the Pharmaceutical Industries...4 The Need for Security...4
More informationM-FILES QUALITY MANAGEMENT SYSTEM SIGNING OPTIONS
M-FILES QUALITY MANAGEMENT SYSTEM SIGNING OPTIONS QMS BUILT-IN DIGITAL SIGNING M-Files QMS contains simple and effective built-in digital document signing. M-Files QMS built-in digital signatures are designed
More informationWhite Paper. Prepared by: Neil Shah Director, Product Management March, 2014 Version: 1. Copyright 2014, ezdi, LLC.
White Paper ezcac: HIPAA Compliant Cloud Solution Prepared by: Neil Shah Director, Product Management March, 2014 Version: 1 Copyright 2014, ezdi, LLC. TECHNICAL SAFEGUARDS Access Control 164.312 (a) (1)
More information21 CFR Part 11 White Paper
21 CFR Part 11 White Paper Version V8.00 SR1 ProLeiT AG Einsteinstrasse 8, D-91074 Herzogenaurach, Germany Phone: +49 (0) 9132 777-0 Fax: +49 (0) 9132 777-150 E-Mail: info@proleit.com Internet: http://www.proleit.com
More informationA ChemoMetec A/S White Paper September 2013
NucleoCounter NC-3000, NucleoView NC-3000 Software and Code of Federal Regulation 21 Part 11; Electronic Records, Electronic Signatures (21 CFR Part 11) A ChemoMetec A/S White Paper September 2013 ChemoMetec
More informationImplement best practices by using FileMaker Pro 7 as the backbone of your 21 CFR 11 compliant system.
21 CRF 11 Electronic Records and Signatures Implement best practices by using FileMaker Pro 7 as the backbone of your 21 CFR 11 compliant system. By Todd Duell What does Title 21 of the Code of Federal
More informationRemote Monitoring of Clinical Trials and EMRs
Remote Monitoring of Clinical Trials and EMRs Sandra SAM Sather, MS, BSN, CCRA, CCRC Vice-President Clinical Pathways LLC samsather@clinicalpathwaysresearch.com Lindsey Spangler, J.D. Associate Director,
More informationUsing SharePoint 2013 for Managing Regulated Content in the Life Sciences. Presented by Paul Fenton President and CEO, Montrium
Using SharePoint 2013 for Managing Regulated Content in the Life Sciences Presented by Paul Fenton President and CEO, Montrium Overview Informative Webinar that aims to provide an overview of how SharePoint
More informationGiftWrap 4.0 Security FAQ
GiftWrap 4.0 Security FAQ The information presented here is current as of the date of this document, and may change from time-to-time, in order to reflect s ongoing efforts to maintain the highest levels
More informationSupplement to the Guidance for Electronic Data Capture in Clinical Trials
Supplement to the Guidance for Electronic Data Capture in Clinical Trials January 10, 2012 Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association Note: The original language of this
More information3.11 System Administration
3.11 The functional area is intended to contribute to the overall flexibility, efficiency, and security required for operating and maintaining the system. Depending on the architecture of the system, system
More informationCompliance Response SIMATIC SIMATIC PCS 7 V8.1. Electronic Records / Electronic Signatures (ERES) Edition 03/2015. Answers for industry.
SIMATIC SIMATIC PCS 7 V8.1 Electronic Records / Electronic Signatures (ERES) Compliance Response Edition 03/2015 Answers for industry. Compliance Response Electronic Records / Electronic Signatures (ERES)
More informationFDA 21 CFR Part 11 Electronic records and signatures solutions for the Life Sciences Industry
FDA 21 CFR Part 11 Electronic records and signatures solutions for the Life Sciences Industry The Rule 21 CFR Part 11 Handwritten signature means the scripted name or legal mark of an individual handwritten
More informationAchieving 21 CFR Part 11 Compliance with Appian
Achieving 21 CFR Part 11 Compliance with Appian Executive Summary Software performance in the life sciences industry has extremely high standards. The FDA and other regulatory bodies require software used
More informationSOLAARsecurity. Administrator Software Manual. 010508 Issue 2
SOLAARsecurity Administrator Software Manual 9499 400 40011 010508 Issue 2 2008. All rights reserved. SOLAAR House, 19 Mercers Row, Cambridge CB5 8BZ.United Kingdom. Telephone +44 (0) 1223 347400, Fax
More informationGuidance for Industry COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS
Guidance for Industry COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS U.S. Department of Health and Human Services Food and Drug Administration Center for Biologic Evaluation and Research (CBER) Center for
More informationImplementation of 21CFR11 Features in Micromeritics Software Software ID
Implementation of 21CFR11 Features in Micromeritics Software Software ID PART 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES Subpart A General Provisions Sec. 11.1 Scope. 11.2 Implementation. 11.3 Definitions.
More informationData Management PACT Workshop: Design & Operation of GMP Cell Therapy Facilities April 10 th -11 th, 2007
Data Management PACT Workshop: Design & Operation of GMP Cell Therapy Facilities April 10 th -11 th, 2007 Data Management Discuss Database Development Design Process Tips Data Normalization Reporting Ideas
More informationSUBJECT: SECURITY OF ELECTRONIC MEDICAL RECORDS COMPLIANCE WITH THE HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996 (HIPAA)
UNIVERSITY OF PITTSBURGH POLICY SUBJECT: SECURITY OF ELECTRONIC MEDICAL RECORDS COMPLIANCE WITH THE HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996 (HIPAA) DATE: March 18, 2005 I. SCOPE This
More informationInformation Technology General Controls Review (ITGC) Audit Program Prepared by:
Information Technology General Controls Review (ITGC) Audit Program Date Prepared: 2012 Internal Audit Work Plan Objective: IT General Controls (ITGC) address the overall operation and activities of the
More informationHIPAA Security Matrix
HIPAA Matrix Hardware : 164.308(a)(1) Management Process =Required, =Addressable Risk Analysis The Covered Entity (CE) can store its Risk Analysis document encrypted and offsite using EVault managed software
More informationSympatec GmbH System-Partikel-Technik WINDOX 4. Electronic Records/ Electronic Signatures Compliance Assessment Worksheet for 21 CFR Part 11
Sympatec GmbH System-Partikel-Technik WINDOX 4 Electronic Records/ Electronic Signatures Compliance Worksheet for 21 CFR Part 11 Note Complete or partial duplication of the present documentation and
More informationThe Impact of 21 CFR Part 11 on Product Development
The Impact of 21 CFR Part 11 on Product Development Product development has become an increasingly critical factor in highly-regulated life sciences industries. Biotechnology, medical device, and pharmaceutical
More informationEnabling SharePoint for 21 CFR Part 11 Compliance - Electronic Signature Use Case
Enabling SharePoint for 21 CFR Part 11 Compliance - Electronic Signature Use Case Sudeep Nambiar Technical Strategist www.linkedin.com/in/sudeepnambiar/ Thanks to our Sponsors! Platinum: Gold: Silver:
More informationepblue GxP oftware manual Software version 20.4.1 075 900.874
ee ab. pblue n. ig. p. manual GxP oftware manual epblue GxP Software manual Software version 20.4.1 075 900.874 Copyright 2012 Eppendorf AG, Hamburg. No part of this publication may be reproduced without
More informationGood Documentation Practices
Good Documentation Practices Clinical Research Operations & Regulatory Support Ann Glasse, RN, BSN, MBA Director, Regulatory Support Author: Johanna Stamates, RN, MA, CCRC, CHRC Objectives Recognize the
More informationShiny Server Pro: Regulatory Compliance and Validation Issues
Shiny Server Pro: Regulatory Compliance and Validation Issues A Guidance Document for the Use of Shiny Server Pro in Regulated Clinical Trial Environments June 19, 2014 RStudio, Inc. 250 Northern Ave.
More informationInformation System Audit. Arkansas Administrative Statewide Information System (AASIS) General Controls
Information System Audit Arkansas Administrative Statewide Information System (AASIS) General Controls ARKANSAS DIVISION OF LEGISLATIVE AUDIT April 12, 2002 April 12, 2002 Members of the Legislative Joint
More informationAssuring E Data Integrity and Part 11 Compliance for Empower How to Configure an Empower Enterprise
Assuring E Data Integrity and Part 11 Compliance for Empower How to Configure an Empower Enterprise 2013 Waters Corporation 1 Agenda Electronic Record regulations, Compliance Policy Guides and Warning
More informationProtecting Official Records as Evidence in the Cloud Environment. Anne Thurston
Protecting Official Records as Evidence in the Cloud Environment Anne Thurston Introduction In a cloud computing environment, government records are held in virtual storage. A service provider looks after
More informationPREPARED BY: AUDIT PROGRAM Author: Lance M. Turcato. APPROVED BY: Logical Security Operating Systems - Generic. Audit Date:
A SYSTEMS UNDERSTANDING A 1.0 Organization Objective: To ensure that the audit team has a clear understanding of the delineation of responsibilities for system administration and maintenance. A 1.1 Determine
More information21 CFR Part 11 Deployment Guide for Wonderware System Platform 3.1, InTouch 10.1 and Historian 9.0
Deployment Guide 21 CFR Part 11 Deployment Guide for Authors: Invensys Operations Management and TSD (Total System Design, an Optimation Company) Table of Contents by Section 1 Before you Begin...............................................................................................
More informationHIPAA Compliance Use Case
Overview HIPAA Compliance helps ensure that all medical records, medical billing, and patient accounts meet certain consistent standards with regard to documentation, handling, and privacy. Current Situation
More informationTIBCO Spotfire and S+ Product Family
TIBCO Spotfire and S+ Product Family Compliance with 21 CFR Part 11, GxP and Related Software Validation Issues The Code of Federal Regulations Title 21 Part 11 is a significant regulatory requirement
More informationElectronic Document and Record Compliance for the Life Sciences
Electronic Document and Record Compliance for the Life Sciences Kiran Thakrar, SoluSoft Inc. SoluSoft, Inc. 300 Willow Street South North Andover, MA 01845 Website: www.solu-soft.com Email: solusoftsales@solu-soft.com
More informationAccess Control and Audit Trail Software
Varian, Inc. 2700 Mitchell Drive Walnut Creek, CA 94598-1675/USA Access Control and Audit Trail Software Operation Manual Varian, Inc. 2002 03-914941-00:3 Table of Contents Introduction... 1 Access Control
More informationINFORMATION SECURITY GOVERNANCE ASSESSMENT TOOL FOR HIGHER EDUCATION
INFORMATION SECURITY GOVERNANCE ASSESSMENT TOOL FOR HIGHER EDUCATION Information security is a critical issue for institutions of higher education (IHE). IHE face issues of risk, liability, business continuity,
More informationUsing the Thermo Scientific Dionex Chromeleon 7 Chromatography Data System (CDS) to Comply with 21 CFR Part 11. Compliance Guide
Using the Thermo Scientific Dionex Chromeleon 7 Chromatography Data System (CDS) to Comply with 21 CFR Part 11 Compliance Guide Table of Contents Introduction... 3 PART 11 ELECTRONIC RECORDS; ELECTRONIC
More informationIT - General Controls Questionnaire
IT - General Controls Questionnaire Internal Control Questionnaire Question Yes No N/A Remarks G1. ACCESS CONTROLS Access controls are comprised of those policies and procedures that are designed to allow
More informationSecurity and Managed Services
iconnect Cloud Archive System Overview Security and Managed Services iconnect Cloud Archive (formerly known as Merge Honeycomb ) iconnect Cloud Archive offers cloud-based storage for medical images. Images
More informationBackup and Recovery FAQs
May 2013 Page 1 This document answers frequently asked questions regarding the Emerson system Backup and Recovery application. www.deltav.com May 2013 Page 2 Table of Contents Introduction... 6 General
More informationEnterprise Content Management for Healthcare
Enterprise Content Management for Healthcare Achieve Operational Efficiency and Responsiveness Long deployment schedules and a lack of systems interoperability present two key challenges to the successful
More informationSoftware Manual Part IV: FDA 21 CFR part 11. Version 2.20
Software Manual Part IV: FDA 21 CFR part 11 Version 2.20 OPTIMA Software Manual Part IV: FDA 21 CFR part 11 BMG LABTECH This manual was designed to guide OPTIMA users through the software features related
More informationInternet Banking Internal Control Questionnaire
Internet Banking Internal Control Questionnaire Completed by: Date Completed: 1. Has the institution developed and implemented a sound system of internal controls over Internet banking technology and systems?
More informationServices Providers. Ivan Soto
SOP s for Managing Application Services Providers Ivan Soto Learning Objectives At the end of this session we will have covered: Types of Managed Services Outsourcing process Quality expectations for Managed
More informationnwstor Storage Security Solution 1. Executive Summary 2. Need for Data Security 3. Solution: nwstor isav Storage Security Appliances 4.
CONTENTS 1. Executive Summary 2. Need for Data Security 3. Solution: nwstor isav Storage Security Appliances 4. Conclusion 1. EXECUTIVE SUMMARY The advantages of networked data storage technologies such
More informationRAYSAFE S1 SECURITY WHITEPAPER VERSION B. RaySafe S1 SECURITY WHITEPAPER
RaySafe S1 SECURITY WHITEPAPER Contents 1. INTRODUCTION 2 ARCHITECTURE OVERVIEW 2.1 Structure 3 SECURITY ASPECTS 3.1 Security Aspects for RaySafe S1 Data Collector 3.2 Security Aspects for RaySafe S1 cloud-based
More informationMS 20341B: Core Solutions of Microsoft Exchange Server 2013
MS 20341B: Core Solutions of Microsoft Exchange Server 2013 Description: In this course, students will learn to configure and manage a Microsoft Exchange Server 2013 messaging environment. This course
More informationCore Solutions of Microsoft Exchange Server 2013
Course 20341B: Core Solutions of Microsoft Exchange Server 2013 Course Details Course Outline Module 1: Deploying and Managing Microsoft Exchange Server 2013 This module describes Exchange Server 2013
More informationPERFORMANCE EVALUATION AUDIT CHECKLIST EXAMPLE. EIIP Volume VI
Final 7/96 APPENDIX E - PERFORMANCE EVALUATION AUDIT APPENDIX E PERFORMANCE EVALUATION AUDIT CHECKLIST EXAMPLE APPENDIX E - PERFORMANCE EVALUATION AUDIT Final 7/96 This page is intentionally left blank.
More informationWaters Empower Software Seamlessly Manages Regulated Data to Aid in 21 CFR Part 11 Compliance
THE ROLE OF WATERS EMPOWER SOFTWARE IN ASSISTING IN 21 CFR PART 11 COMPLIANCE Waters Empower Software Seamlessly Manages Regulated Data to Aid in 21 CFR Part 11 Compliance Summary The objective of this
More informationComputerized System Audits In A GCP Pharmaceutical Laboratory Environment
IVTGXP_july06.qxd 6/28/06 1:09 PM Page 36 Computerized System Audits In A GCP Pharmaceutical Laboratory Environment By Maintaining data integrity for both clinical laboratory processes and patient data
More informationHospital Certified Electronic Health Record (EHR) Technology Questionnaire
Page 1 of 10 Hospital Certified Electronic Health Record (EHR) Technology Questionnaire Thank you for taking time to complete this questionnaire. The Office of Inspector General (OIG) is conducting this
More informationAchieving PCI COMPLIANCE with the 2020 Audit & Control Suite. www.lepide.com/2020-suite/
Achieving PCI COMPLIANCE with the 2020 Audit & Control Suite 7. Restrict access to cardholder data by business need to know PCI Article (PCI DSS 3) Report Mapping How we help 7.1 Limit access to system
More informationImplementing CitectSCADA to meet the requirements of FDA 21 CFR Part 11
Implementing CitectSCADA to meet the requirements of FDA 21 CFR Part 11 Version 2.0 July 2008 FDA 21 CFR Part 11 READY Reversed out on solid background colour Background In 1991, members of the pharmaceutical
More informationNetWrix SQL Server Change Reporter
NetWrix SQL Server Change Reporter Version 2.2 Administrator Guide Contents NetWrix SQL Server Change Reporter Administrator Guide 1. INTRODUCTION... 3 1.1 KEY FEATURES... 3 1.2 LICENSING... 4 1.3 HOW
More information