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Compliance | Data Management | Predicate Rules (GLP, GMP, GCP & QSR)
Regulatory Guidance Documents | Security | Standardized Data Formats
Risk Management |
Standards and Regulations | Validation
Compliance
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How to Use Risk Management for 21 CFR Part 11 Compliance
This webcast discusses the impact that
risk management will have on your Part 11 compliance program,
and on how you can develop strategies to “justify and document”
risk assessment. It also presents an overview of the FDA’s new
“cGMP for the 21st Century” Initiative and how it impacts
regulatory compliance for GMP and GLP-compliant organizations.Learn more about the current direction and progress of the FDA in
response to technological progress:
New strategies and new thinking by the FDA toward the regulated
pharmaceutical industry by Lester M. Crawford, Acting
Commissioner of the FDA in a speech before Global Pharmaceutical
Strategies Seminar on May 25, 2004.
http://www.fda.gov/oc/speeches/2004/gpss0525.html
21 CFR Part 11 and Risk Assessment: Adapting Fundamental
Methodologies to a Current Rule
Pharmaceutical Technology Europe 05/2004 - 68KB ISPE 21 CFR Part 11 white paper - goal of this paper is to provide the philosophy necessary to apply risk management, and to encourage manufacturing innovation and technological advances. This philosophy is based on the ideas in the new FDA cGMP initiative. We believe that this approach is equally applicable to all FDA regulated industries.
Risk-Based Approach to 21 CFR Part 11 - 183KB The FDA may decide in the future to further codify the requirements for drug discovery records. If it does so, it is likely that the requirements will follow the same standards as Part 11. In general, it is a good idea to design any Most companies have focused their Part 11 compliance efforts on manufacturing, on clinical trials, and on development, because that has been the focus of FDA auditing efforts. This paper discusses the design of a discovery automation system to comply with Part 11.
Discovery Automation: The Benefits of 21 CFR Part 11 Compliance — Even if the FDA Never Asks for Your Records - 484KB Guidance for Industry Part 11, Electronic Records; Electronic Signatures - Scope and Application
Draft Guidance - Feb 2003 - 44KB E-manufacturing enables immediate communication
between the various islands of shop floors, corporate business
systems and laboratory information management systems so that the
entire enterprise can react together to solve problems. Going
paperless in manufacturing can allow one to manage the master data
across the enterprise’s physical boundaries. What is needed is an
application-independent, non-invasive data management system for the
lab, the plant and beyond.
Cycle time reduction in manufacturing using a scientific data
management system - 92KB NetRegulus offers data management solutions to FDA-regulated organizations. The following link provides access to NetRegulus' library of free white papers and presentations. Topics include 21 CFR Part 11 and other related subjects. http://www.netregulus.com/white_papers.htm
Pharmaceutical companies that rely on the Internet for electronic information exchange need robust security to maintain trust, to protect an organization from liability, and to comply with regulations such as the U.S. Food and Drug (FDA) Administration's 21 Code of Federal Regulations (CFR), Part 11, concerning electronic records and electronic signatures. Public Key Infrastructure (PKI) meets market and regulatory requirements for securing electronic information in the pharmaceutical industry.
Meeting FDA Requirements - 89KB
Commentary on the “Durable Media” Issue, July 16, 2002.
By John McKenney, President, SEC Associates, Inc.
Durable Media - 35KB
"Biometrics: The Password You’ll Never Forget" from LC•GC Europe - October 2000 issue. R.D. McDowall, McDowall Consulting, Bromley, Kent, UK.
Biometrics - 695KB
Interesting thoughts about the importance and legal issues of metadata from the CIO Council Web Page On Metadata.
What Every CIO Needs to Know About Metadata - 52KB
An informative link to European Union directives and commission reports on Electronic Signatures and Electronic Records.
www.bmck.com/ecommerce/eu.htm
The QSR-GMP Help program uses the familiar Windows® help interface to provide quick reference to a specific sections of the Medical Devices; Current Good Manufacturing Practice Final Rule; Quality System Regulation (GMP). QSR-GMP Help Trial Version provides instant access to the following important FDA documents: Medical Devices; Current Good Manufacturing Practice Final Rule; Quality System Regulation (GMP) Guidance for Industry: General Principles of Software Validation
www.qsrhelp.com/ereshelp.shtml
A discussion of some terms and definitions, the scope of the regulations and some recent regulatory actions and, an outline of some approaches to aid qualification of computer networks and the associated infrastructure. This is not intended to be an all encompassing article but to simulate thought within IS departments. By R.D.McDowall, McDowall Consulting
Qualification of Computer Networks and Infrastructure - 48KB
A PDF file from the Biometrics Working Group titled "Best Practices in Testing and Reporting Performance of Biometric Devices"
www.afb.org.uk - 53KB
White Paper on PerkinElmer Turbochrom Client/Server and Workstation Software regarding support for Electronic Records and Electronic Signatures.
Turbochrom Software and 21 CFR Part 11 - 311KB
The author is Robert McDowall of McDowall Consulting, Bromley, Kent, UK.
An article describing the impact of the Electronic Records and Electronic Signatures rule on pharmaceutical and other chromatography laboratories. -191K 5 part Chromatography Data Systems (CDS). The author is Robert McDowall of McDowall Consulting, Bromley, Kent, UK.
A series of papers on related subject matter.
The author is Robert McDowall of McDowall Consulting, Bromley, Kent, UK.
High Tech FBI Tactics Raise Privacy Questions
Pharmaceutical Companies team with Vendors and gear up to comply with 21CFR Part11.
Meeting The Mandate
Cognizant Technology Solutions (Cognizant)
whitepaper on CFR Part 11 compliance
The Cognizant Approach
The October, 2001 issue of "The Silver Sheet" by F-D-C Reports is primarily dedicated to 21 CFR Part 11 issues. It contains updated commentary on the latest developments by leaders in this field, including Paul Motise (FDA), John McKenney (SEC Associates), Paul D'Eramo (Johnson & Johnson), Ludwig Huber (Agilent Technologies) and others. Also included are updates on the joint PDA/ISPE Part 11 guidance series. Free reprints can be ordered at:
www.secassociates.com
under "What's New".
SEC Principal Compliance Consultant Lisa Olson is published in Volume 35, Issue 3 of the Drug Information Journal, a scientific publication of the Drug Information Association (DIA). Ms. Olson's article, entitled "Electronic Record Challenges for Clinical Systems", contains timely information of particular relevance to professionals involved with electronic records and Good Clinical Practices (GCPs). Free reprints can be ordered at:
www.secassociates.com under "What's New". Datastream provides the asset management functionality to address 21 CFR 11 regulations across the enterprise. This white paper explains some of those issues, including audit trails, security, document control, and extensive signature procedures, and how Datastream's asset management solutions deliver the tools companies need to validate a system
TREATING 21 CFR 11 CHALLENGES WITH DATASTREAM - 3.1MB
NetRegulus offers data management solutions to FDA-regulated organizations. The following link provides access to NetRegulus' library of free white papers and presentations. Topics include 21 CFR Part 11 and other related subjects.
www.netregulus.com/white_papers.htm
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Data Management
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Experiences Migrating Mass Spectrometry Data
Between Platforms and Applications and
Retiring Obsolete Legacy Systems: A Case
Study
By David Browne - Covance Laboratories,
Terry Thompson - Covance Laboratories, David
Mole - McDowall Consulting, and R.D.
McDowall - McDowall Consulting
"Advantage Management - Shortening the Time to Decision as a Way to Shorten Time to Market." An article regarding clinical data management relative to 21CFRpart11. "Bringing a new product to market is extremely expensive, and each day’s delay reduces future revenue by an estimated $1 million. The need to manage that process is mandated if not intuitive. So, here, based on new enabling technologies, we propose time-to-decision as the optimum response." Reprinted from APPLIED CLINICAL TRIALS, Volume 9, Number 11, Pages 34-38, November 2000
Advantage Management - 40KB Top Ten Questions to ask when evaluating Change Management Software for computer systems when using the Migration Method to change
electronic records
ten_questions.pdf - 97KB "Keeping up with genomically generated drug targets while meeting the FDA’s data quality standards requires a different kind of mapping."
The Cartography of Compliance Discusses how valuable internal data and metadata can be in the life sciences industry once it becomes accurately categorized and related. This article shows how narrowly focused data warehouses actually hinder the potential for a multi-purpose Business Intelligence environment comments: Published in Intelligent Enterprise, October 8, 2002.
Central Intelligence
"How Raw Are Your Data — 2000?" from LC•GC Europe - September 2000 issue. What constitutes electronic records for chromatography data systems now? Why do we need to change our approach to managing electronic records compared with paper ones? R.D. McDowall, McDowall Consulting, Bromley, Kent, UK.
How Raw Are Your Data - 2000? - 890KB "Is Your Data Safe?" - by Brian Robinson, Interactive Week, November 27, 2000. Article on the importance of protecting the integrity of your data. Firewalls are not sufficient!
Is Your Data Safe? - 78KB An article on measuring return on IT
investments.
"Does Corporate America Know How to Measure Payoff in Information Technology Investment?" By M. Khosrow-pour, D.B.A. Associate Professor of Information Systems The Pennsylvania State University.
www.docmanage.com
howtomeasuredocmanagementmagjanfeb00.pdf - 36KB The Information Security Committee of the American Bar Association Section of Science and Technology released for public comment of its five-year project - the PKI Assessment Guidelines (the "PAG").
www.abanet.org/scitech/ec/isc/
Let's stop wasting $ 78 Billion a year. - 325KB Drug Companies on Speed - 170KB Princeton Softech’s white paper discusses the issues of archiving relational data, how to develop an archiving strategy, creating an active archive and the benefits of active archiving.
Archiving Complex Enterprise Databases - 87KB
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Predicate Rules (GLP, GMP, GCP & QSR)
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GLP:
21 CFR 58 Good Laboratory Practice for Non-Clinical Lab Studies
GCP:
21 CFR 310 New Drugs 21 CFR 312 Investigational New Drug Application 21 CFR 314 Applications For FDA Approval To Market A New Drug 21 CFR 510 New Animal Drugs 21 CFR 511 New Animal Drugs For Investigational Use 21 CFR 514 New Animal Drug Applications 21
CFR 54 Financial Disclosure By Clinical Investigators 21 CFR 50 Protection Of Human Subjects
GMP:
21 Code of Federal Regulations Parts 210 and 211
Part 210
Current good manufacturing practice in manufacturing, packaging, or holding of drugs: General Part 211
Current good manufacturing practice for finished pharmaceuticals.
www.fda.gov/cder/dmpq/cgmpregs.htm
QSR:
21 CFR 820 Quality System Regulation
21 CFR 806 Medical Devices; Reports Of Corrections And Removals 21 CFR 803 Medical Device Reporting 21 CFR 808 Exemptions From Federal Preemption Of State And Local Medical Device Requirements 21 CFR 814 Premarket Approval of Medical Devices
Food-related "GMPs"; GOOD FOOD PRACTICES
21 CFR106/107 Infant Formula QC Procedures
Part 106
Part 107
21 CFR 110
Current Good Manufacturing Practice in Manufacturing, Packing and Holding Human Food
21 CFR 113
Thermally Processed and Acidified Low-Acid Canned Foods
21 CFR 123
Fish and Fishery Products
21 CFR 129
Processing and Bottling of Bottled Drinking Water
21 CFR PART 114
Acidified Foods
Other Regs:
21 CFR Part 1 Exports: Notification and Recordkeeping Requirements Annotated Predicate Rules (GLP, GCP, GMP) courtesy of Dr. Bob McDowall, McDowall Enterprises, UK
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Regulatory Guidance Documents
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Guidance for
Industry, FDA Reviewers and Compliance on:
Off-The-Shelf Software Use in Medical
DevicesGuidance for Industry:
Cybersecurity for Networked Medical Devices
Containing Off-the-Shelf (OTS) Software
Guidance for Industry and FDA Staff:
Class II Special Controls Guidance Document:
Newborn Screening Test Systems for Amino
Acids, Free Carnitine, and Acylcarnitines
Using Tandem Mass Spectrometry
Agency Guidances
Promote Comprehensive Efforts to Minimize
Risks While Preserving the Benefits of
Medical Products
The Food and Drug Administration
(FDA) is announcing the availability of
three draft guidances to help industry
develop risk management activities when
needed for some drugs and biological
products.
Federal Register Notice (May 5,
2004):
Premarketing Risk Assessment
http://www.fda.gov/OHRMS/DOCKETS/98fr/2004d-0187-gdl0001.doc
Development and Use of Risk
Minimization Action Plans
http://www.fda.gov/OHRMS/DOCKETS/98fr/2004d-0188-gdl0001.doc
Good Pharmacovigilance Practices and
Pharmacoepidemiologic Assessment
http://www.fda.gov/OHRMS/DOCKETS/98fr/04d-0189-gdl0001-5767dft.doc
Guidance for Industry Part 11, Electronic Records; Electronic Signatures - Scope and Application
Part 11 Final Guidance Issued - 44KB
The November 2000 Department of Justice Guide for Federal Agencies, Legal Considerations In Designing and Implementing Electronic Processes. This is a GPEA implementation guide that, as you will see, echoes part 11 principles and particulars: from time stamps to audit trails to biometrics,
to controls to deter fraud and abuse.
DoJ Guide on Electronic Processes - 404KB NARA e-Records Management Guidance. The Government Paperwork Elimination Act (GPEA, P.L. 105-277) requires that, when practicable, Federal agencies use electronic forms, electronic filing, and electronic signatures to conduct official business with the public by 2003. In doing this, agencies will create records with business, legal and, in some cases, historical value. This guidance focuses on records management issues involving records that have been created using electronic signature technology. It supplements the Office of Management and Budget (OMB) guidance for agencies implementing the GPEA, as well as other National Archives and Records Administration (NARA) guidance.
e-Records Management Guidance - 82KB The National Archives and Records Administration (NARA) guidance document "Records Management Guidance for Agencies Implementing Electronic Signature Technologies" is now available. This document was produced in response to the Government Paperwork Elimination Act (GPEA).
Records Management Guidance... The CIO Council has prepared a guide for
federal agencies called Securing Electronic Government. The guide defines five security goals - - availability, authentication and identification, confidentiality, integrity, and non-repudiation - and uses examples from the federal security environment.
Securing Electronic Government - 158KB
Here's the URL for the attached guide. Procedures and Guidance: Implementation of the Government Paperwork Elimination Act specifically states that electronic records and their related electronic signatures are not to be denied legal effect, validity, or enforceability merely because they are in electronic form, and encourages Federal government use of a range of electronic signature alternatives.
Federal Register/Vol. 65, No. 85/ Tuesday, May 2, 2000 - 171KB
This is one of a series of products that has been prepared by the ICA Committee on Electronic Records. The mandate of the Committee, which was established in 1993, is to undertake study and research, promote the exchange of experience and draft standards and directives concerning the creation and archival processing of electronic records. The three products are as follows: Guide for Managing Electronic Records from an Archival Perspective, Electronic Records Programs: Report on the 1994/95 Survey, Electronic Records: Literature Review.
www.ica.org/cgi-bin/ica.pl?0508_e NIST Special Publication on Intrusion Detection Systems - 963KB New PIC/S Guide - 1.4MB FDA New General Principles of Software Validation Guidance - 162KB FDA New Computerized Systems Used in Clinical Trials Guidance - 47KB FDA New Guidance for Industry: Bioanalytical Method Validation - 63KB
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Risk Management
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"Guidance for Industry: PreMarketing Risk
Assessment"
Discusses the generation, acquisition,
analysis, and presentation of premarketing
safety data. Risk assessment consists of
identifying and characterizing the nature,
frequency, and severity of the risks
associated with the use of a product. Risk
assessment occurs throughout a product’s
lifecycle, from the early identification of
a potential product, through the
premarketing development process, and after
approval during marketing. Premarketing risk
assessment represents the first step in this
process, and this guidance focuses on risk
assessment prior to marketing.
Guidance for Industry: Premarketing Risk
Assessment - 88KB"Guidance for
Industry: Development and Use of Risk
Minimization Action Plans"
Provides guidance to industry on the
development, implementation, and evaluation
of risk minimization action plans for
prescription drug products, including
biological drug products. In particular, it
gives guidance on:
- initiating and designing plans
called risk minimization action plans or
RiskMAPs to minimize identified product
risks
- selecting and developing tools to
minimize those risks
- evaluating RiskMAPs and monitoring
tools
- communicating with FDA about
RiskMAPs
- the recommended components of a
RiskMAP submission to FDA.
Guidance for Industry: Development and Use
of Risk - 81KB
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Security
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OVERVIEW OF TECHNOLOGICAL CONTROLS SUPPORTING SECURITY REQUIREMENTS IN PART 11
Orlando López, IM Systems Part 11 Remediation Program Manager, McNeil Consumer Healthcare
Technologies Supporting Security - 524KB
Recommendations of the National Institute of Standards and Technology
Guidelines On E-Mail Security - 672KB
Recommendations of the National Institute of Standards and Technology
Procedures for Handling Security Patches - 3.32MB
NIST draft publication: Engineering Principles for IT Security (A baseline for achieving security) addresses software lifecycles.
Engineering Principles in IT Systems Feb 2001 draft - 116KB A US General Accounting Office article called, "Advances and Remaining Challenges to Adoption of Public Key Infrastructure Technology" which reviews the federal government's public key infrastructure (PKI) strategy and initiatives to assess the issues and challenges the government faces in adopting this new technology.
Information Security - 686KB
Gary Gamerman’s Fall 2002 Workshop slides on Information security, Part11/HIPPA, including "hacker-side" background summary of security considerations, Key HIPPA issues, and major compliance related points for IT involved projects and services.
Managing IT Operations Outside of Your Organization A March 2001 OPEN-SOURCE SECURITY article called, "OPEN SOURCE UNDER THE HOOD". Vendors are increasingly including open-source components in their commercial products. What impact does this trend have on product security?
Open Source Under the Hood - 83.6KB
This is a white paper from V I S A U .S .A . Cardholder Information Security Program. This is a discussion of their PKI and their security measures. There is also a good glossary for reference.
Cardholder Information Security Program - 451KB
Article from April 2001 entitled, "REACH OUT AND ID SOMEONE ACCESS CONTROL" BY MANDY ANDRESS. This discussed how tokens can provide the best means of authenticating its VPN users. For organizations employing VPNs, the technology helps improve productivity through an inexpensive conduit.
Reach Out and ID Someone - 122KB
This is a white paper from Verisign called, "Strong Security in Multiple Server Environments" , New technologies such as load balancing devices and SSL accelerators, Secure Server IDs from VeriSign, Inc. are discussed as the bottom line in security for information exchange between servers and client browsers and server-to-server exchange.
Strong Security in Multiple Server Environments - 295KB
"Big Brother Rides Shotgun" By Nancy Gohring, Interactive Week August 13, 2001 6:11 AM PT You think privacy is a big issue online? Just wait until wireless gets more pervasive. The potential for wireless to let Big Brother track your every move may drive some people to run for the woods, leaving technology behind.
www.zdnet.com
Big Brother Rides Shotgun - 21.7KB
An article from MBizCentral called, "Wireless Data Networks Called 'Inherently Insecure'" By Robert Lemos, ZDNet,USA Today 07/13/01. This discussed how a new way to attack wireless networks underscores the lack of security for PC owners using the airwaves to connect their computers.
Wireless Data Networks Called 'Inherently Insecure' - 5.53KB
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Standardized Data Formats
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A series of links from the Australian State of Victoria regarding XML. Very informative:
Victorian Electronic Records Strategy
The XML.ORG Registry is a community resource for accessing the fast-growing body of XML specifications, schemas and vocabularies being developed for vertical industries and horizontal applications. It is designed to foster collaboration and enhance communication within industries adopting XML, preventing unnecessary overlap, duplication and confusion.
www.xml.org/xml/news_market.shtml
XML.com features a rich mix of information and services for the XML community. The site is designed to serve both people who are already working with XML and those HTML users who want to "graduate" to XML's power and complexity. A core feature of the site is the Annotated XML Specification, created by Tim Bray, co-editor of XML 1.0 and a contributing editor for XML.com.
www.xml.com
A selection of white papers regarding XML and its usage with respect to legacy data and new data unification strategies going forward.
www.xmls.com/resources/?idref=resources
www.w3.org/Signature A link to the current W3C draft for the XML Digital Signature Standard. The standard will allow an XML document to include a digital signature to secure the contents of the XML document.
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Standards and Regulations
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Final version of the Electronic Signatures Act as signed by the President of the United States. Basically gives electronic signatures legal equivalency to written signatures.
S-761 Electronic Signatures
in Global and National Commerce Act - 136KB 21 CFR Part 11. Electronic Records; Electronic Signatures; Final Rule Electronic Submissions; Establishment of Public Docket; Notice.
21 CFR Part 11 Final Rule - 253KB "The Ultimate Archives: The National Archives may have found a way to make e-records available for generations to come" from the website of Federal Computer Week, an interesting article about really long-term electronic record archiving.
www.fcw.com/fcw/articles/2000/0828/cov-archive-08-28-00.asp HUMAN DRUG CGMP NOTES is a periodic memo for FDA personnel on Current Good Manufacturing Practice Issues on Human Use Pharmaceuticals, issued by the Division of Manufacturing and Product Quality, HFD-320, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug
Administration
There are various relevant Q&A with Paul Motise in Human Drug GMP Notes, Pre 1999
www.fda.gov/cder/dmpq/cgmpnotes.htm The Department of Health and Human services has published National Standards for Electronic Transactions - 45 CFR Parts 160 and 162 Health Insurance Reform: Standards for Electronic Transactions; Announcement of Designated Standard Maintenance Organizations; Final Rule and Notice. National Standards for Electronic Transactions Final Rule Published in Federal Register on Aug. 17, 2000. Also see aspe.hhs.gov/admnsimp/ for FAQ's regarding the rule.
National Standards for Electronic Transactions Final Rule - 473KB HIPAA - In 1996, Congress enacted Public Law 104-191, known as the Health Information Portability and Accountability Act, to amend ERISA, the IRS law, and the Public Health Act. The law was based on the Kennedy-Kassenbaum bill and has its roots in the 1993 Clinton "Healthcare Proposals". The primary intent of the law is to provide better access to health insurance and to criminalize health care billing fraud. Below are a series of links of interest:
hippo.findlaw.com/hipaa.html
www.aha.org/hipaa/hipaa_home.asp
www.hipaa-iq.com/ An overview in PDF format on HR1714, "Electronic Signatures In Global and National Commerce Act".
Electronic Signatures in Global and National Commerce Act - 28KB This link contains notes from a Society of Quality Assurance sub-committee meeting, SA CVIC Meeting 6/10/97 with Paul Motise, FDA Computer Expert Inspector--Project Leader on the Electronic Signatures Regulations. The notes were taken and made available to the public by Karen Raskasky.
www.raskaskygroup.com/motise.html Functional requirements and testing document for electronic records in management systems, in the UK government. It is a project led by the Public Record Office and is the outcome of an Invest to Save Budget project, which aims to develop cross-government requirements for electronic records management systems.
ERM Systems Evaluation Scheme 1758.8 KB
www.pro.gov.uk/recordsmanagement/eros/invest/default.htm German Digital Signature Law Final Version, June 13, 1997
This is a translation of the final version of the Digital Signature Law which was approved by the German parliament on June 13, 1997.
http://www.kuner.com/data/sig/digsig4.htm
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Validation
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"This article discusses the "how to" aspects involved in validating Building Automation Systems (BAS) in regulated environments. Standard methodology ensures that manufacturers choose systems that can be validated, that those systems are properly designed, that they are completely commissioned, that they are validated/qualified according to FDA guidelines, and fully operational.
Validation Requirements for Building Automation Systems in Pharmaceutical and Bio-Medical Manufacturing Facilities
"New CSV Model" - A presentation of the relevance of Part 11 as the new computer system validation model. It provides examples of how this model is applicable to manufacturing computer systems. This presentation was part of the Computer & Software Validation conference organized by the Barnett International Conference Group (January, 2001, Brussels, Belgium). The May/June issue of the Pharmaceutical Engineering includes an article covering the same subject.
New CSV Model - 143KB
"Have You Checked Your Device?" When a regulation calls for device checks — what does this really mean? R.D. McDowall, McDowall Consulting, Bromley, Kent, UK.
Have You Checked Your Device - 186KB
"Testing Automated Manufacturing Processes" - A presentation on testing of PLC-based systems, including the impact of 21 CFR Part 11. This presentation was part of the Computer & Software Validation Processes conference organized by the Institute for International Research (July 26-26, 2000, Arlington, VA).
Testing Automated Manufacturing Processes - 355KB
5 part Chromatography Data Systems (CDS). The author is Robert McDowall of McDowall Consulting, Bromley, Kent, UK.
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