• Customer Center
  • Partner Center
  • Store
  • Contact us
DEESFRITPTRU日本語 (JA)
EN
  • Products
    • By business needs
      • Overview
      • Business Process Management – BPM
      • Corporate Performance Management – CPM
      • Enterprise Asset Management – EAM
      • Enterprise Content Management – ECM
      • Enterprise Quality Management – EQM
      • Enterprise Risk Management – ERM
      • Environmental, Social and Corporate Governance Management – ESG
      • Governance, Risk and Compliance Management – GRC
      • Human Development Management – HDM
      • Innovation and Change Management – ICM
      • Enterprise Service Management – ESM
      • Product Lifecycle Management – PLM
      • Project and Portfolio Management – PPM
      • Supplier Lifecycle Management – SLM
    • By industry
      • Overview
      • Aerospace and Defense
      • Agribusiness
      • Architecture, Engineering & Construction
      • Automotive
      • Chemicals
      • Consumer Goods
      • Education
      • Energy & Utilities
      • Financial Services
      • Food & Beverage
      • Healthcare
      • High-tech
      • Medical Devices
      • Mining & Metals
      • Pharmaceuticals & Biotechnology
      • Public Sector & Associations
      • Retail
      • Transportation & Logistics
    • By regulation
      • Overview
      • AS9100
      • BPMN
      • BSC
      • CBOK
      • CMMI
      • COBIT
      • COSO
      • FDA 21 CFR Part 11
      • FDA 21 CFR Part 820
      • FSSC 22000
      • GDPR
      • IATF 16949
      • ISO 10015
      • ISO 13485
      • ISO 14000
      • ISO 15189
      • ISO 19011
      • ISO 20000
      • ISO 22000
      • ISO 22301
      • ISO 26000
      • ISO 27001
      • ISO 31000
      • ISO 37001
      • ISO 45001
      • ISO 50001
      • ISO 55000
      • ISO 9000
      • ISO/IEC 17025
      • ISO/TS 14253
      • ITIL
      • OHSAS 18000
      • PMBOK
      • Six Sigma
      • SOX
    • All products
      • Overview
      • Action Plan
      • Analytics
      • APQP-PPAP
      • Archive
      • Asset
      • Audit
      • Calibration
      • Capture
      • Competence
      • Customer
      • Document
      • FMEA
      • Form
      • Incident
      • Inspection
      • Kanban
      • Knowledge Base
      • Maintenance
      • Meeting
      • MSA
      • PDM
      • Performance
      • Portfolio
      • Problem
      • Process
      • Project
      • Protocol
      • Request
      • Requirement
      • Risk
      • SPC
      • Storeroom
      • Supply
      • Supplier
      • Survey
      • Time Control
      • Training
      • Workflow
    • SoftExpert Excellence Suite
    • SoftExpert Excellence Suite
  • Services
    • Overview
    • Training
    • Cloud Computing
    • Consulting and Implementation
    • Customization Services
    • Integration
    • Performance Optimization
    • Service Hours Pack
    • Support
    • Validation
  • Company
    • About us
    • Contact us
    • Business Partners
      • Find a Partner
      • Strategic alliances
      • Become a Partner
      • Qualification Form
    • Careers
    • Channel of Reports
    • Events
  • Customers
    • Overview
    • Success cases
    • Testimonials
    • Video Case
  • Resources
  • News
  • Blog
    • Customer Center
    • Partner Center
    • Store
    • Contact us

    FDA 21 CFR Part 11

    Request a Live Demo
  • Download / Contact
    • Brochure
    • More Information
    • Request a Live Demo
    • The Solution
    • Benefits
    • Brochure
    • More Information
    • Request a Live Demo

    Home » FDA 21 CFR Part 11

    The Challenge

    The Part 11 of Title 21 of the Code of Federal Regulations (21 CFR Part 11) establishes security requirements to the life sciences industries, that follows its guidelines to ensure that electronic records and electronic signatures are legitimate and authentic, allowing in many situations to replace their paper equivalents, and also to improve the security and trustworthy of IT systems.

    Demand for medicine is increasing fast, at the same time that regulatory agencies makes more rigid the approval process for new medicine. The strong regulation is posing challenges, and executives needs to drive all efforts to ensure that stringent regulatory compliance and quality standards are met, to avoid product safety troubles or regulatory agencies punishments, that can weaken the company image in the market, reducing revenues and market share.

    FDA 21 CFR Part 11 Solution

    SoftExpert offers the most advanced and comprehensive software solution for compliance management, that meets the demanding needs of various global regulations. SoftExpert Excellence Suite helps companies to comply with FDA 21 CFR Part 11, while lowering the costs, maximizing success, increasing productivity and reducing risks.

    The SoftExpert solution enables organizations to easily meet FDA 21 CFR Part 11 requirements, providing resources to manage records, documents, reviews, access controls, and also trainings, non-conformances, KPIs, processes and others, boosting organizational efficiency, reducing rework and waste. With online collaboration capabilities, the organization and managers can communicate and be updated about the compliance initiatives, involving more users, teams, offices and business units with a systematic and unified approach that keeps the company ready for the FDA audits.

    • Document control

      Document control

    • Controlled copy and digital signature

      Controlled copy and digital signature

    • Document review

      Document review

    • Audit trail

      Audit trail

    Main Benefits

    Reduce efforts to effectively comply with FDA, ISO and other regulations.

    Streamline the elaboration, review and approval of compliance documents.

    Eliminate scattered, duplicates and obsolete documents.

    Ensure the access to the updated documents to prevent process deviations.

    Easily responds to FDA audits with available and traceable information.

    Promote the company commitment to quality and customer satisfaction.

    Provide a better customer experience with products and services.

    Brochure / Demo More Information Request a Live Demo

    Know some success stories

    More Resources

    Featured Resources

    Ebook

    5 Strategic Processes for ECM Success

    Read this eBook to learn more about 5 strategic processes for ECM (Enterprise Content Management) success.
    Learn more
    DOWNLOAD

    Webinar

    7 essential practices for optimizing Enterprise Content Management (ECM)

    Seven essential practices for optimizing Enterprise Content Management (ECM) through a unified approach.
    Learn more
    Watch now

    Ebook

    How to improve your document management system

    Read this eBook to know some easy-to-implement strategies to maximize the full potential of your document management process.
    Learn more
    DOWNLOAD
    More Resources

    See also

    FDA 21 CFR Part 820
    SoftExpert ECM
    SoftExpert EQM
    Por favor, preencha o formulário e fale conosco
    *Required field

    E-mail*

    Nome Completo*

    Cargo*

    Telefone*

    Empresa*

    Indústria*




    País*




    Estado*




    Necessidade de compra de uma solução*




    Mensagem

    Ao clicar no botão abaixo, você confirma que leu e aceita nossa Política de Privacidade










    Products

    • SoftExpert Excellence Suite
    • By Business needs
    • By Industry
    • By Regulation
    • All Products
    x
    Request a Software Demo:
    Invalid E-mail.

    Overview

    • Resources
    • Services
    • News
    • Store
    • Blog

    Company

    • About Us
    • Business Partners
    • Customers
    • Customer Center
    • Partner Center
    • Channel of Reports
    • Careers

    Contacts

    CSC: +55 (47) 2101 9999
    Contact us
    Facebook
    Twitter
    LinkedIn
    YouTube
    Instagram

    Newsletter

    By registering, you agree to our Privacy Policy.

    Invalid e-mail

    Softexpert Copyright © SoftExpert Software for Performance Excellence.
    All trademarks, trade names, service marks, and logos referenced herein belong to their respective companies.
    • Política de privacidade

    Online Sales

    Online Sales SOftExpert
    SoftExpert
    Online Sales

    Online Sales SOftExpert

    Hi, can we help you with more information about our solutions?

    Yes No, thank you.

    Nós usamos cookies para oferecer a melhor experiência possível em nosso site. Para saber mais, visite nossa Privacy Policy
    Ao continuar a usar este site ou ao fechar esta caixa, você concorda com o uso de cookies.

    Ok
    SoftExpert
    • Products
      • By business needs
        • Overview
        • Business Process Management – BPM
        • Corporate Performance Management – CPM
        • Enterprise Asset Management – EAM
        • Enterprise Content Management – ECM
        • Enterprise Quality Management – EQM
        • Enterprise Risk Management – ERM
        • Environmental, Social and Corporate Governance Management – ESG
        • Governance, Risk and Compliance Management – GRC
        • Human Development Management – HDM
        • Innovation and Change Management – ICM
        • Enterprise Service Management – ESM
        • Product Lifecycle Management – PLM
        • Project and Portfolio Management – PPM
        • Supplier Lifecycle Management – SLM
      • By industry
        • Overview
        • Aerospace and Defense
        • Agribusiness
        • Architecture, Engineering & Construction
        • Automotive
        • Chemicals
        • Consumer Goods
        • Education
        • Energy & Utilities
        • Financial Services
        • Food & Beverage
        • Healthcare
        • High-tech
        • Medical Devices
        • Mining & Metals
        • Pharmaceuticals & Biotechnology
        • Public Sector & Associations
        • Retail
        • Transportation & Logistics
      • By regulation
        • Overview
        • AS9100
        • BPMN
        • BSC
        • CBOK
        • CMMI
        • COBIT
        • COSO
        • FDA 21 CFR Part 11
        • FDA 21 CFR Part 820
        • FSSC 22000
        • GDPR
        • IATF 16949
        • ISO 10015
        • ISO 13485
        • ISO 14000
        • ISO 15189
        • ISO 19011
        • ISO 20000
        • ISO 22000
        • ISO 22301
        • ISO 26000
        • ISO 27001
        • ISO 31000
        • ISO 37001
        • ISO 45001
        • ISO 50001
        • ISO 55000
        • ISO 9000
        • ISO/IEC 17025
        • ISO/TS 14253
        • ITIL
        • OHSAS 18000
        • PMBOK
        • Six Sigma
        • SOX
      • All products
        • Overview
        • Action Plan
        • Analytics
        • APQP-PPAP
        • Archive
        • Asset
        • Audit
        • Calibration
        • Capture
        • Competence
        • Customer
        • Document
        • FMEA
        • Form
        • Incident
        • Inspection
        • Kanban
        • Knowledge Base
        • Maintenance
        • Meeting
        • MSA
        • PDM
        • Performance
        • Portfolio
        • Problem
        • Process
        • Project
        • Protocol
        • Request
        • Requirement
        • Risk
        • SPC
        • Storeroom
        • Supply
        • Supplier
        • Survey
        • Time Control
        • Training
        • Workflow
      • SoftExpert Excellence Suite
      • SoftExpert Excellence Suite
    • Services
      • Overview
      • Training
      • Cloud Computing
      • Consulting and Implementation
      • Customization Services
      • Integration
      • Performance Optimization
      • Service Hours Pack
      • Support
      • Validation
    • Company
      • About us
      • Contact us
      • Business Partners
        • Find a Partner
        • Strategic alliances
        • Become a Partner
        • Qualification Form
      • Careers
      • Channel of Reports
      • Events
    • Customers
      • Overview
      • Success cases
      • Testimonials
      • Video Case
    • Resources
    • News
    • Blog

      padrao

      • DE (DE)
      • EN
      • ES (ES)
      • FR (FR)
      • IT (IT)
      • PT (PT)
      • RU (RU)
      • 日本語 (JA)