21 CFR Part 11 Compliance Solution for Access Databases - Cimcon Software

Nov 06, 2025

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Access databases play a vital role in GxP applications such as batch records, clinical data, and manufacturing logs. However, without proper controls, they risk data integrity issues. To meet FDA requirements, Access databases must be fully 21 CFR Part 11 compliant.

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21 CFR Part 11 Compliance Solution for Access Databases - Cimcon Software

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21 CFR Part 11 Electronic Records Electronic Signatures

Slide No. 2

1.28k views • 34 slides

21 CFR PART 11 REGULATIONS RECOMMENDATIONS FOR CHANGES FDA PUBLIC MEETING ON PART 11 REGULATIONS – JUNE 11, 2004

21 CFR PART 11 REGULATIONS RECOMMENDATIONS FOR CHANGES FDA PUBLIC MEETING ON PART 11 REGULATIONS – JUNE 11, 2004. NATIONAL ELECTRICAL MANUFACTURERS ASSOCIATION (NEMA) RICHARD EATON - NEMA RAVI NABAR, PH.D. – EASTMAN KODAK. National Electrical Manufacturers Association (NEMA).

604 views • 25 slides

21 CFR 50.24

21 CFR 50.24. Toby A. Silverman, M.D. Branch Chief, Clinical Review Branch Division of Hematology, Office of Blood December 14, 2006. 21 CFR 312. Regulations governing conduct of investigations with investigational new drugs

528 views • 7 slides

Investigational Device Exemptions 21 CFR Part 812

A Review for OCRA US RAC Study Group September 2005 Ginger Clasby, MS Promedica International gclasby@promedica-intl.com 714-799-1617 x 25. Investigational Device Exemptions 21 CFR Part 812. IDE About the Regulation.

649 views • 30 slides

21 CFR Part 11 A Food Industry Perspective FDA Public Meeting June 11, 2004

21 CFR Part 11 A Food Industry Perspective FDA Public Meeting June 11, 2004. Sia Economides Center Director Center for Development of Research Policy and New Technologies National Food Processors Association. National Food Processors Association (NFPA)

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Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum 21 CFR Part 11 Considerations November 14, 20

Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum 21 CFR Part 11 Considerations November 14, 2002. Overview. 21 CFR Part 11 Introduction Panel Discussion Questions. 21 CFR Part 11 – What is it?. Self Imposed

244 views • 8 slides

Webinar On 21 CFR 11 Compliance for Excel Spreadsheets

Compliance Trainings will provide insight into various aspects of Food Compliance like prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy and dietary supplements through industry experts.

178 views • 2 slides

Part 11 Compliance

Part 11 Compliance. FDA will inspect Part 11 controls relating to drugs as they are described in the ‘Part 11, Electronic Records; Electronic Signatures — Scope and Application’ guidance (August 2003)

162 views • 1 slides

CDER’s 21 CFR Part 11 Implementation Study

CDER’s 21 CFR Part 11 Implementation Study. Greg Brolund Associate Director, Office of Information Technology, CDER/FDA. Background . CDER heard many concerns about the implementation of Part 11 Timing Legacy Systems Inconsistent information from FDA 483’s etc.

490 views • 21 slides

21 CFR Part 11 Electronic Records & Electronic Signatures

21 CFR Part 11 Electronic Records & Electronic Signatures. Svend Martin Fransen Principal Scientist, QS CRS Quality Services Novo Nordisk A/S. Contents . 21CFR11 history The important aspects of 21CFR11 Equivalent requirements in EU legislation

1.09k views • 35 slides

What does 21 CFR 11 Require?

What does 21 CFR 11 Require?. The FDA requires corporate compliance on the areas listed below. This document specifically deals with the FDA audit trail . Validation is required for all systems ( “all versions of application software, operating systems, and software development tools.”)

397 views • 2 slides

21 CFR Part 11

21 CFR Part 11. Rules for complying with the rules. Marilyn M. Marshall QAO Office of the Vice-President for Research Lindy Brigham March 30, 2006. The Rules. The rules and your lab The rules and your business The rules Your role in interpreting the rules. Rules and Research Labs .

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Criteria For Approval 45 CFR 46.111 21 CFR 56.111

Criteria For Approval 45 CFR 46.111 21 CFR 56.111. Minimized risks Reasonable risk/benefit ratio Equitable subject selection Informed consent process Informed consent documentation Data monitored for safety Confidentiality/privacy maintained Vulnerable populations protected.

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Provisions and Implementation of 10 CFR Part 21

Provisions and Implementation of 10 CFR Part 21. Presented to: National Spent Nuclear Fuel Program Strategy Meeting Presented by: Timothy C. Gunter Supervisor, Regulatory Compliance Branch Regulatory Affairs Division Office of Civilian Radioactive Waste Management April 15, 2009.

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Good Laboratory Practice CFR 21 Part 58

Good Laboratory Practice CFR 21 Part 58. A Review for OCRA US RAC Study Group September 2005 Ginger Clasby, MS Promedica International gclasby@promedica-intl.com 714-799-1617 x 25. GLP What It Is.

926 views • 15 slides

Industry Coalition on 21 CFR Part 11

Industry Coalition on 21 CFR Part 11. Recommendations for Achieving Compliance with the Electronic Records and Electronic Signatures Regulation. Who are we?. Advanced Medical Technology Association (AdvaMed) Consumer Healthcare Products Association (CHPA)

318 views • 20 slides

Excel Spreadsheet Validation for FDA 21 CFR Part 11

This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application. http://www.compliance4all.com/

578 views • 5 slides

FDA's New Enforcement of 21 CFR Part 11

FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings. The seminar will have the answers. And using industry proven case studies on how to avoid 483 inspectional observations and warning letters attendees will learn how to prepare their organization for trouble-free Part 11 related inspections.

166 views • 5 slides

21 CFR Part 11 Compliance Software

21 CFR Part 11 is used to manage and store electronic records and electronic signatures and also helps in processing the electronic data that FDA predicate rules require them to maintain. Qualityze provides best 21 CFR Part 11 compliance software for pharmaceutical, medical devices manufacturing companies that can manage and store electronic records and signatures as equivalent to paper records and handwritten signatures.

141 views • 5 slides

21 CFR Part 11 Compliance for SaaS/Cloud Applications

This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments. For More Details: https://www.complianceonline.com/21-cfr-part-11-compliance-for-saas-cloud-applications-seminar-training-80202SEM-prdsm?channel=slideserve

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21 CFR Part 11 – A Risk Management Perspective November 13, 2003

21 CFR Part 11 – A Risk Management Perspective November 13, 2003. Proposed Agenda. 21 CFR Part 11 Baseline Recent 21 CFR Part 11 Developments Integration with other Legislation Lessons Learned Risk Management Perspective An Example Considerations. 21 CFR Part 11 Baseline.

225 views • 20 slides

21 CFR Part 11 Checklist - eLeaP - Easy 21 CFR Part 11 Checklist

21 cfr part 11 compliance checklist requires a statement of the credibility of electronic records. To look after consistency, framework managers need to have a framework that offers the capacity to represent client consents for each record vault in the structure.

106 views • 5 slides

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21 CFR Part 11 Compliance Solution for Access Databases - Cimcon Software

21 CFR Part 11 Compliance Solution for Access Databases - Cimcon Software

Presentation Transcript

21 CFR Part 11 Electronic Records Electronic Signatures

21 CFR PART 11 REGULATIONS RECOMMENDATIONS FOR CHANGES FDA PUBLIC MEETING ON PART 11 REGULATIONS – JUNE 11, 2004

21 CFR 50.24

Investigational Device Exemptions 21 CFR Part 812

21 CFR Part 11 A Food Industry Perspective FDA Public Meeting June 11, 2004

Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum 21 CFR Part 11 Considerations November 14, 20

Webinar On 21 CFR 11 Compliance for Excel Spreadsheets

Part 11 Compliance

CDER’s 21 CFR Part 11 Implementation Study

21 CFR Part 11 Electronic Records &amp; Electronic Signatures

What does 21 CFR 11 Require?

21 CFR Part 11

Criteria For Approval 45 CFR 46.111 21 CFR 56.111

Provisions and Implementation of 10 CFR Part 21

Good Laboratory Practice CFR 21 Part 58

Industry Coalition on 21 CFR Part 11

Excel Spreadsheet Validation for FDA 21 CFR Part 11

FDA's New Enforcement of 21 CFR Part 11

21 CFR Part 11 Compliance Software

21 CFR Part 11 Compliance for SaaS/Cloud Applications

21 CFR Part 11 – A Risk Management Perspective November 13, 2003

21 CFR Part 11 Checklist - eLeaP - Easy 21 CFR Part 11 Checklist

21 CFR Part 11 Electronic Records & Electronic Signatures