rsdm and 21 CFR Part 11
|
|
- Elisabeth Malone
- 8 years ago
- Views:
Transcription
1 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 Copyright 2014
2 rsdm and 21 CFR Part 11 Meeting the 21 CFR Part 11 Burden without Overburdening Note Italicized text indicates text copied directly from 21 CFR Part 11. rsdm is both a new and a new type of electronic document management system (EDMS). Built entirely in the cloud, rsdm is a SaaS-based (software as a service) solution with no installation required. The solution is truly a service and, as such, can meet 21 CFR Part 11 s requirements, but the traditional installed software assumptions associated with validating rsdm do not all apply. VRS has created this white paper to list each of 21 CRF Part 11 s main requirements and to describe, in detail, how rsdm meets each regulatory hurdle. Let s frame out what rsdm is, so we can focus on the sections of Part 11 s requirements that are applicable. Part 11 and Defining rsdm rsdm is: An Electronic Document Management System that supports management of Electronic Records The system manages records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations. This part also applies to electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations. o ELECTRONIC RECORD - Electronic record means any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system. An EDMS capable of managing Electronic Records with Electronic, Digital or Handwritten Signatures applied via an external process. o ELECTRONIC SIGNATURE Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature. o 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. P1
3 o HANDWRITTEN SIGNATURE Handwritten signature means the scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form. The act of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark. An OPEN SYSTEM Open system means an environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system. rsdm is not: An ELECTRONIC SIGNATURE system rsdm does not apply electronic, digital, or handwritten signatures to documents as part of its area of control, but will provide compliant management of Electronic Records that have had signatures previously applied to them. Part 11 and rsdm Context for EDM systems in General Subpart A. Sec Implementation. (a) For records required to be maintained but not submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that the requirements of this part are met. (b) For records submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that: (1) The requirements of this part are met; and (2) [ the documents are part of a submission format FDA accepts electronically ] rsdm meets all the defined requirements of an Open System under 21 CFR Part 11. Subpart B Section Controls for Open Systems Persons who use open systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, as appropriate, the confidentiality of electronic records from the point of their creation to the point of their receipt. Such procedures and controls shall include those identified in 11.10, as appropriate, and additional measures such as document encryption and use of appropriate digital signature standards to ensure, as necessary under the circumstances, record authenticity, integrity, and confidentiality. rsdm MEETS THIS REQUIREMENT by establishing a secure https connection both at both ends of the connection (the rsdm cloud-based repository and the user s connection), ensuring data is P2
4 appropriately encrypted and secured. rsdm does name create electronic or digital signatures on documents, but will manage those signed Electronic Records in a compliant Open System environment. Subpart B--Electronic Records Section Controls for closed systems. Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. Such procedures and controls shall include the following: (a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. rsdm MEETS THIS REQUIREMENT and can be validated successfully based on FDA validation requirements. VRS has developed a simple, targeted Validation package that, based on rsdm s simplicity and adherence to core compliance needs, can be executed in less than three (3) days. (b) The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the electronic records. rsdm MEETS THIS REQUIREMENT by enabling easy access to documents, either in native source for PDF formats for any user account with access to the document in the rsdm repository. (c) Protection of records to enable their accurate and ready retrieval throughout the records retention period. rsdm MEETS THIS REQUIREMENT be securely storing documents in a repository protected by https security, seen as an industry standard for protection of on-line transactions. Authorized users can easily access Electronic Records via rsdm s security model. (d) Limiting system access to authorized individuals. rsdm MEETS THIS REQUIREMENT by maintaining a user name and role-based security model. Non-admin users have three levels of access: Author, Editor, and Reviewer, as well as an additional privilege: Approver. Access to any Electronic Record is granted solely based on the level of privilege granted to the user s account for that record. (e) Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying. P3
5 rsdm MEETS THIS REQUIREMENT by maintaining a secure, computer generated audit log of any action taken by a user on a document, including action, date/time, and user name. rsdm ties the audit trail to the Electronic Record itself, ensuring the audit trail is maintained as long as the record exists. (f) Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate. rsdm MEETS THIS REQUIREMENT in two ways. Use of workflows in rsdm are very limited, leading to a very easy validation, implementation, and ultimate use. rsdm does, ensure that the key tenets of Electronic Record management (version control, granting/changing access, etc) are managed through simple, easy to follow workflow sequences. (g) Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand. rsdm MEETS THIS REQUIREMENT by verifying access against a user s privileges for each individual Electronic Record using its internal security model. Electronic signatures are not applied using the rsdm system. If Electronic or Digital Signatures are desired, they can be applied using a separate process, then the esigned documents can be loaded into and managed by rsdm. (h) Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction. rsdm MEETS THIS REQUIREMENT by ensuring every login is via a valid rsdm user ID. rsdm is accessible from any internet-connected device, but can only be accessed by providing a valid rsdm user name and matching password. (i) Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks. rsdm MEETS THIS REQUIREMENT by keeping the credentials of the system developers and designers on file and available for review. (j) The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification. RSDM MEETS THIS REQUIREMENT by not addressing Electronic Signatures as part of its area of control. VRS can, however, recommend proper policies and procedures for use or Electronic Signatures with any Electronic Records managed with rsdm. (k) Use of appropriate controls over systems documentation including: P4
6 (1) Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance. rsdm MEETS THIS REQUIREMENT with its existing documentation suite. (2) Revision and change control procedures to maintain an audit trail that documents timesequenced development and modification of systems documentation. rsdm MEETS THIS REQUIREMENT with its existing documentation suite. Subpart B--Electronic Records Sec Signature manifestations. rsdm does not apply Electronic Signatures to Electronic Records. Subpart B--Electronic Records Sec Signature/record linking. Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means. rsdm MEETS THIS REQUIREMENT by managing Electronic Records that have already had electronic signatures applied via some other external Electronic/Digital Signature process. SubPart C Electronic Signatures rsdm does not apply Electronic or Digital Signatures. SubPart C does not apply. Context within FDA s Risk-based Validation approach We suggest that your decision to validate computerized systems, and the extent of the validation, take into account the impact the systems have on your ability to meet predicate rule requirements. You should also consider the impact those systems might have on the accuracy, reliability, integrity, availability, and authenticity of required records and signatures. Even if there is no predicate rule requirement to validate a system, in some instances it may still be important to validate the system. We recommend that you base your approach on a justified and documented risk assessment and a determination of the potential of the system to affect product quality and safety, and record integrity. For instance, validation would not be important for a word processor used only to generate SOPs. - FDA Guidance for IndustryPart 11, Electronic Records;Electronic Signatures Scope and Application, August 2003 P5
7 Consistent with FDA s risk-based approach to Validation of computerized systems, the purpose of rsdm, and the above information relative to rsdm s ability to meeting 21 CFR Part 11 s compliance burden, we believe that rsdm can be implemented in any organization subject to 21 CFR Part 11 in a fully compliant manner. P6
Implementation 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 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 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 informationAssessment of Vaisala Veriteq vlog Validation System Compliance to 21 CFR Part 11 Requirements
/ WHITE PAPER Assessment of Vaisala Veriteq vlog Validation System Compliance to 21 CFR Part 11 Requirements The 21 CFR Part 11 rule states that the FDA view is that the risks of falsification, misinterpretation,
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 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 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 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 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 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 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 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 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 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 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 informationTools 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 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 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 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 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 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 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 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 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 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 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 informationHow To Control A Record System
Thermo Scientific Qtegra Intelligent Scientific Data Solution (ISDS) Software for 21 CFR Part 11 Compliant Laboratories Technical Note 43106 Key Words Compliance, Electronic Records, 21 CFR Part 11 Goal
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 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 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 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 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 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 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 informationFor technical assistance, please contact: Thermo Nicolet Corporation 5225 Verona Road Madison WI 53711-4495
The information in this publication is provided for reference only. All information contained in this publication is believed to be correct and complete. Thermo Nicolet Corporation shall not be liable
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 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 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 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 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 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 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 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 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 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 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 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 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 informationGuidance for Industry. 21 CFR Part 11; Electronic. Records; Electronic Signatures. Time Stamps
Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures Time Stamps Draft Guidance This guidance document is being distributed for comment purposes only. Comments and suggestions
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 informationGuidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application
Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research
More informationGuidance for Industry. 21 CFR Part 11; Electronic Records; Electronic Signatures. Electronic Copies of Electronic Records
Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures Electronic Copies of Electronic Records Draft Guidance This guidance document is being distributed for comment purposes only.
More informationGuidance for Industry. 21 CFR Part 11; Electronic Records; Electronic Signatures. Maintenance of Electronic Records
Draft Guidance for Industry -- Not For Implementation Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures Maintenance of Electronic Records Draft Guidance This guidance document
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 informationWaters Empower 2 Software Seamlessly Manages Regulated Data to Aid in 21 CFR Part 11 Compliance
THE ROLE OF WATERS EMPOWER 2 SOFTWARE IN ASSISTING IN 21 CFR PART 11 COMPLIANCE Waters Empower 2 Software Seamlessly Manages Regulated Data to Aid in 21 CFR Part 11 Compliance Summary The objective of
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 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 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 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 information21 CFR Part 11 LIMS Requirements Electronic signatures and records
21 CFR Part 11 LIMS Requirements Electronic signatures and records Compiled by Perry W. Burton. Version 1.4, 8 Sept 2014 Table of contents 1. Purpose of this document 1 1.1 Notes to version 1.4 1 1.2 About
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 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 informationGood Electronic Records Management (GERM) Using IBM Rational ClearCase and IBM Rational ClearQuest
A technical discussion of Good Electronic Records Management using Rational software from IBM 04/03 Good Electronic Records Management (GERM) Using IBM Rational ClearCase and IBM Rational ClearQuest Matthew
More informationElectronic Records and Signatures: Compliance with Title 21 CFR Part 11 Requirements
Electronic Records and Signatures: Compliance with Title 21 CFR Part 11 Requirements Version 4.5. June 2015 Contents 1 Introduction... 3 2 Definitions (21 CFR Part 11: para 11.3)... 3 3 Administrative
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 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 informationConsiderations for validating SDS Software v2.x Enterprise Edition for the 7900HT Fast Real-Time PCR System per the GAMP 5 guide
WHITE PAPER SDS Software v2.x Enterprise Edition Considerations for validating SDS Software v2.x Enterprise Edition for the 7900HT Fast Real-Time PCR System per the GAMP 5 guide This white paper describes
More informationAlfresco CoSign. A White Paper from Zaizi Limited. March 2013
A White Paper from Zaizi Limited March 2013 Zaizi Ltd is registered in England and Wales with the registration number 6440931. The Registered Office is 222 Westbourne Studios, 242 Acklam Road, London W10
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 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 informationGuidance for electronic trial data capturing of clinical trials
Guidance for electronic trial data capturing of clinical trials 1 st November, 2007 Japan Pharmaceutical Manufacturing Association pg. 1 Table of Contents 1. Background... 3 2. Purpose... 3 3. Scope...
More informationElectronic Signature Assurance & the Digital Chain-of-Evidence
Electronic Signature Assurance & the Digital Chain-of-Evidence Executing Legally Admissible Digitally Signed Records by Jacques R. Francoeur, B.A.Sc., M.A.Sc., MBA Table of Contents 1. Executive Summary
More informationAuditing Chromatographic Electronic Data. Jennifer Bravo, M.S. QA Manager Agilux Laboratories
Auditing Chromatographic Electronic Data Jennifer Bravo, M.S. QA Manager Agilux Laboratories Outline Raw data paper or electronic record? Controls for electronic data Auditing electronic records Warning
More informationGuidance for Industry
Guidance for Industry Electronic Source Data in Clinical Investigations U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for
More informationOLEY VALLEY SCHOOL DISTRICT
No. 829 SECTION: OPERATIONS OLEY VALLEY SCHOOL DISTRICT TITLE: ELECTRONIC SIGNATURES ADOPTED: February 19, 2015 REVISED: 829. ELECTRONIC TRANSACTIONS, RECORDS AND SIGNATURES 1. Purpose 2. Authority 73
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 informationOpenText Regulated Documents for the Life Sciences Industry:
M A R C H 2 0 1 3 OpenText Regulated Documents for the Life Sciences Industry: 21 CFR Part 11 Compliance helps organizations in the Life Sciences industry achieve compliance with the requirements of Rule
More informationIssues in Information Security and Verifiability for Biomedical Technology Companies
Ryan Morlok rmorlok2@uiuc.edu Issues in Information Security and Verifiability for Biomedical Technology Companies Introduction Most people are aware of the existence of the Food and Drug Administration
More informationTHE ROLE OF WATERS NUGENESIS SDMS IN 21 CFR PART 11 COMPLIANCE
THE ROLE OF WATERS NUGENESIS SDMS IN 21 CFR PART 11 COMPLIANCE The objective of this article is to discuss the 21 CFR Part 11 compliance utility of the Waters NuGenesis Scientific Data Management System
More informationLife sciences solutions compliant with FDA 21 CFR Part 11
Life sciences solutions compliant with FDA 21 CFR Part 11 System 800xA facilitates regulatory compliance As part of ABB s strategy we have invested considerably in the development of advanced solutions
More informationThe biggest challenges of Life Sciences companies today. Comply or Perish: Maintaining 21 CFR Part 11 Compliance
S E P T E M B E R 2 0 1 3 Comply or Perish: The biggest challenges of Life Sciences companies today are maintaining a robust product pipeline and reducing time to market while complying with an increasing
More informationSoftware. For the 21 CFR Part 11 Environment. The Science and Technology of Small Particles
Software For the 21 CFR Part 11 Environment The Science and Technology of Small Particles 21 CFR Part 11 Solution confirm Software The Code of Federal Regulations Title 21, Part 11, was implemented by
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 informationRackspace Archiving Compliance Overview
Rackspace Archiving Compliance Overview Freedom Information Act Sunshine Laws The federal government and nearly all state governments have established Open Records laws. The purpose of these laws is to
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 informationINTRODUCTION. This book offers a systematic, ten-step approach, from the decision to validate to
INTRODUCTION This book offers a systematic, ten-step approach, from the decision to validate to the assessment of the validation outcome, for validating configurable off-the-shelf (COTS) computer software
More informationThe Infrastructure Audit Trail and Part 11
The Infrastructure Audit Trail and Part 11 Pamela Campbell Senior Consultant, Validation DataCeutics, Inc. campbelp@dataceutics.com February 28, 2003 DataCeutics, Inc. 2003 Why am I Qualified to Make this
More informationSignature Requirements for the etmf
Wingspan Technology Signature Requirements for the etmf A Regulatory and Technological Assessment Kathie Clark Director, Product Management Wingspan Technology 1 November 2012 Signature Requirements for
More informationQualification Guideline
Qualification Guideline June 2013 Disclaimer: This document is meant as a reference to Life Science companies in regards to the Microsoft O365 platform. Montrium does not warrant that the use of the recommendations
More informationMinnesota State Colleges and Universities System Procedures Chapter 5 Administration Procedures associated with Board Policy 5.22
Minnesota State Colleges and Universities System Procedures Chapter 5 Administration Procedures associated with Board Policy 5.22 5.25.1 Use of Electronic Part 1. Purpose. This procedure establishes requirements
More informationU.S. FDA Title 21 CFR Part 11 Compliance Assessment of SAP Records Management
U.S. FDA Title 21 CFR Part 11 Compliance Assessment of SAP Records Management Disclaimer These materials are subject to change without notice. SAP AG s compliance analysis with respect to SAP software
More informationGuidance for Industry
Guidance for Industry Electronic Source Data in Clinical Investigations DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft
More informationExcel Spreadsheets and FDA Device Regulations
Excel Spreadsheets and FDA Device Regulations Dan O Leary CBA, CQA, CQE, CRE, SSBB, CIRM President Ombu Enterprises, LLC Dan@OmbuEnterprises.com www.ombuenterprises.com 603-209-0600 1 Outline Overview
More informationSIMATIC SIMATIC PCS 7 V8.0. Electronic Records / Electronic Signatures. Compliance Response. Answers for industry.
SIMATIC SIMATIC PCS 7 V8.0 Electronic Records / Electronic Signatures Compliance Response Edition 09/2012 Answers for industry. Compliance Response Electronic Records / Electronic Signatures for SIMATIC
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 information5 FAM 140 ACCEPTABILITY AND USE OF ELECTRONIC SIGNATURES
5 FAM 140 ACCEPTABILITY AND USE OF ELECTRONIC SIGNATURES 5 FAM 141 PURPOSE (CT-IM-112; 07-30-2010) (Office of Origin: IRM/OPS/ITI/SI/IIB) The purpose of this FAM chapter is to enable the Department to
More informationRisk-Based Approach to 21 CFR Part 11
3109 W. Dr. Martin Luther King, Jr. Blvd., Suite 250 Tampa, FL 33607 USA Tel: 813/960-2105 Fax: 813/264-2816 www.ispe.org Risk-Based Approach to 21 CFR Part 11 The 21 CFR Part 11 regulation is a comprehensive
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 informationSponsor Site Questionnaire FAQs Regarding Maestro Care
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
More informationFDA CFR PART 11 ELECTRONIC RECORDS, ELECTRONIC SIGNATURES
Document: MRM-1004-GAPCFR11 (0005) Page: 1 / 18 FDA CFR PART 11 ELECTRONIC RECORDS, ELECTRONIC SIGNATURES AUDIT TRAIL ECO # Version Change Descrition MATRIX- 449 A Ga Analysis after adding controlled documents
More information