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FDA 21 CFR Part 820

Overview

The medical device industry is under increasing pressure to adhere to FDA rules for process compliancy. Without compliance, these companies are unable to bring products to market and are subject to financial, civil and potentially criminal sanctions.

Along with increasing competition in the market for medical devices and the decreases in available staff, it’s clear why these companies look to effective methods for ensuring compliance with government policy and procedure while decreasing time-to-market and increasing competitiveness.

FDA 21 CFR Part 820 is a set of regulatory rules laid out by the U.S. Food and Drug Administration (FDA) for the purpose of ensuring the adequacy of quality systems involved in the manufacture of pharmaceutical products and medical devices. Unlike Part 11 Compliance, Part 820's GMP regulations are mandatory for all medical device companies.

SoftExpert offers the most advanced and comprehensive software solution for compliance management that meets the stringent needs of the FDA 21 CFR Part 820. SoftExpert Excellence Suite helps companies follow the regulation, while lowering the costs of compliance, maximizing success, increasing productivity and reducing risks.

SoftExpert’s solutions enables organizations to easily follow FDA 21 CFR Part 820, providing resources to manage processes, audits, risks, calibrations, maintenance, projects, quality records, boosting organizational efficiency, reducing rework and waste. With online collaboration capabilities, organizations and managers can communicate and be updated on the continuous improvement initiatives, involving more users, teams, offices and business units with a systematic and unified approach, turning quality guidelines into actions.

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  • CarrierSoftExpert Solution has streamlined data sharing for our quality system and has contributed to reducing impacts on the environment through doing away with the need for storing piles of original and obsolete paper documents for auditing purposes.

    Solange Amaral – Human Resource Analyst

  • OpetrecOnline access to wherever we offer services ensures us speedy responses, through reliable and updated information, which, in turn, facilitates decision making and customer satisfaction.

    José Andrade – Opetrec Manager

  • CoinduThe SoftExpert facilitates and speeds up activities, and the system was considered highly suitable for the renewal of ISO/TS 16949 and ISO 14001.

    Cristina Pereira – Gerente adjunta de Informática

  • CTA-ContinentalSE Document has provided the means to streamline our document control, through excellent drilldown options for searching and registering documents, a systematic workflow
    tool for sending pending tasks to system users, as well as really cutting down on the need for printed copies.


    Ângela Fischer

  • Coca-ColaThe implementation of SE Action streamlined our continuous improvement process for managing actions, especially through the workflow functionality. This facilitates the verification of occurrence causes and drafting correction actions.

    Gustavo Martins – Quality Department Assistant

  • Universal Leaf TabacosSE Document manages ISO standardization documentation to facilitate compliance, as well as all other document types. The workflow system provides great distribution copy control, approval, revision, printed copies, and document retrieval search capabilities. Currently, there are over 1,100 users and 3,500 registered documents.

    Carla Regina Schmitt

  • MenegottiOur productivity and reliability increased greatly. The software helped us to meet the ISO/TS 16949 standard requirements, providing security in the daily routine of the Engineering area and auditing, while easily proving full compliance with the standard and customer requirements.

    Jeferson R. F. dos Santos – MENFUND Unit Manager

  • Mitsubishi MotorsWe have achieved improved dependability as well as standardization in our processes to assure measurement consistency and the required monitoring to verify conformity in our products. This adds enhanced safety and quality to our customers.

    Helton Calaça – SPC Technical Support

  • Group RoullierSE Document completely meets our document control requirements, facilitates retrieval, and manages the entire document revision process.

    Janaina Salatti – Quality Supervisor

  • Laboratório GloboThe SE Project was implemented quickly and the time required for the adoption of the solution by the users was quite natural, considering that the pharmaceutical segment is legally required to work with reliable and secure records that guarantee the quality of products and do not represent risks to the population.

    Randel Moreira – IT Manager

Screenshots (Click to Enlarge)

Calibration record
Project Control
Risk assessment
Value comparisons

Benefits

  • Employ industry-proven solution that is seamlessly integrated.
  • Reduce the cost involved to comply with FDA regulations.
  • Increase end user acceptance and productivity.
  • Monitor and report product defects.
  • Automate the required regulatory data collection of device-history records.
  • Manage product complaints and adverse events.
  • Modify procedures to suit unique business requirements.
  • Access procedures while maintaining complete document security.
  • Maintain complete audit trail records.
  • Manage product specifications.

About SoftExpert

SoftExpert is a market leader in software and services for enterprise-wide business process improvement and compliance management, providing the most comprehensive application suite to empower organizations to increase business performance at all levels and to maximize industry-mandated compliance and corporate governance programs.

Founded in 1995, SoftExpert has a rich history of innovation and growth as a true industry leader. More than 300,000 users from 2,000 organizations worldwide trust SoftExpert applications to ensure the highest standards of efficiency, quality and innovation for their products, services and processes.

By streamlining and integrating all levels and operations, SoftExpert applications also enable organizations to address an ever-increasing variety and number of international standards, laws and regulations that affect business operations by delivering enhanced compliance capabilities based on industry-specific best practices.

SoftExpert solutions are used by leading corporations in all kinds of industries, including consumer products, automotive, food and beverage, mining and metals, high tech and IT, energy and utilities, government and public sector, financial services, transportation and logistics, healthcare, education, medical devices and many others.

Along with its extensive network of resellers spread across all continents, SoftExpert also provides hosting, implementation, post-sales support, and validation services for its solutions to ensure that customers realize the maximum value from their investments.

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