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  • 21 CFR 11 Compliance For Excel Spreadsheets

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    ComplianceTrainings
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    In Dec. 2010, the FDA has stepped up enforcement for 21 CFR 11 compliance with spreadsheets being considered as low hanging fruit for FDA inspectional findings. Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment.

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    21 CFR 11 Compliance for Excel Spreadsheets

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    In Dec. 2010, the FDA has stepped up enforcement for 21 CFR 11 compliance with spreadsheets being considered as low hanging fruit for FDA inspectional findings. Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment.

    Direitos autorais:

    Attribution Non-Commercial (BY-NC)
    Baixe no formato XLSX, PDF, TXT ou leia online no Scribd
    Sinalizar o conteúdo como inadequado
    158 visualizações2 páginas

    21 CFR 11 Compliance For Excel Spreadsheets

    Enviado por

    ComplianceTrainings
    In Dec. 2010, the FDA has stepped up enforcement for 21 CFR 11 compliance with spreadsheets being considered as low hanging fruit for FDA inspectional findings. Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment.

    Direitos autorais:

    Attribution Non-Commercial (BY-NC)
    Baixe no formato XLSX, PDF, TXT ou leia online no Scribd
    Sinalizar o conteúdo como inadequado
    de 2

    Contact Us : +1-416-915-4458 We Empower, You Comply!

    21 CFR 11 Compliance for Excel Spreadsheets


    Thursday, April 11, 2013 Duration : 90 Minutes 10:00 AM PDT | 01:00 PM EDT Speaker | Angela Bazigos

    To register for this webinar please visit our website www.compliancetrainings.com

    Webiar Description:
    In Dec. 2010, the FDA has stepped up enforcement for 21 CFR 11 compliance with spreadsheets being considered as low hanging fruit for FDA inspectional findings. Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment.

    Areas Covered in the Session :


    > Requirements for Excel Spreadsheets > FDA Part 11 Validation Guidance > Compliance Problems with Spreadsheets > Design Specifications for 21 CFR 11 compliance > Documentation for Part 11 > Future Trends in 21 CFR 11 compliance for Excel Spreadsheets

    Who Will Benefit:


    > Quality Managers > Quality Engineers > Small business owners > GxP > Consultants > Quality VPs > IT VPs To register for this webinar please visit our website www.compliancetrainings.com

    Speaker Profile:
    Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley and has almost 30 years experience in life science. She has received a patent for speeding up software compliance and has applied for patents aimed at speeding up software compliance and FDA software audits. She has co-authored Computerized Systems in Clinical Research with the FDA, DIA and Academia and teaches classes in project management, computer systems validation, quality assurance and IT. She is the Vice President of the Pacific

    Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley and has almost 30 years experience in life science. She has received a patent for speeding up software compliance and has applied for patents aimed at speeding up software compliance and FDA software audits. She has co-authored Computerized Systems in Clinical Research with the FDA, DIA and Academia and teaches classes in project management, computer systems validation, quality assurance and IT. She is the Vice President of the Pacific Regional Chapter of Society of Quality Assurance and writes articles for the SQA journal. She is also a member of DIA, RAPS and CVIC. She was recently inducted into Stanfords Whos Who for contributions to the Life Sciences industry.

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