FDA 21 CFR Part 820 Regulation - Quality System

FDA 21 CFR Part 820 Regulation - Quality System
  • Online 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    		      
    Opetrec
  • Our 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    		      
    Menegotti
  • SE 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    		      
    CTA-Continental
  • The 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    		      
    Coindu
  • SE Document completely meets our document control requirements, facilitates retrieval, and manages the entire document revision process.
    Janaina Salatti – Quality Supervisor    		      
    Group Roullier
  • We 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    		      
    Mitsubishi Motors
  • SoftExpert 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    		      
    Carrier
  • The 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    		      
    Coca-Cola
  • SE 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    		      
    Universal Leaf Tabacos
  • The 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    		      
    Laboratório Globo

    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.

     

    Benefits

    Compliance is just one of the benefits gained. But some other perceived - and actual - benefits experienced by medical device companies include:

    • Provides quality and compliance assurance.
    • Shortens product development lifecycles.
    • Facilitates design-for-compliance initiatives.
    • Minimizes preparation time for FDA audits.
    • Reduces the cost of regulatory compliance.
    • Improves business processes.
    • Integrates compliance management capabilities into current business processes.
    • Meets demand quickly and cost-effectively.
    • Reduces variability within processes.
    • Provides detailed work-in-progress visibility and traceability.
    • Reduces the organization's overall risk.
    • Anticipates process and product deviation.
    • Implements timely preventive actions.
    • And more .

    The Challenge

  • 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.

    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.

    The following issues may impact a medical device company in its compliance efforts:

    • Fast-changing market demands.
    • Manage a multitude of internal and external risks.
    • Need for continuous design innovation.
    • Innovate and ensure safety while still protecting profit margins.
    • Chaotic economic cycles.
    • Critical information not readily available for workers to do their jobs effectively.
    • Create complete and secure device master records.
    • Validate every stage of the device lifecycle – from design concept to quality release.
    • Maximize organizational efficiencies.
    • Reduce earnings volatility.
    • Reduce compliance risk.

    These are significant challenges. However, the implementation of a management system helps medical device organizations achieve continuous performance improvement.

    To deal with these challenges and to comply with rigorous FDA regulatory requirements, SoftExpert Excellence Suite is an integrated web-based management system, designed to help medical device companies to fully meet 21 CFR PART 820 regulations.

    SoftExpert Excellence Suite is an integrated web-based management system, designed to help medical device companies to fully meet 21 CFR PART 820 regulations.

    With SoftExpert Excellence Suite such organizations can easily and effortlessly:

    • Achieve 21 CFR PART 820 compliancy quicker.
    • 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.
    • Manage closed-loop CAPA processes.
    • Communicate quality issues.
    • Modify procedures to suit unique business requirements.
    • Access procedures while maintaining complete document security.
    • Maintain complete audit trail records.
    • Eliminate rework.
    • Manage product specifications.
    • Maintain accessible and secure product information.
    • Minimize costs by saving on consulting services.
    • Ensure the authenticity, integrity, and confidentiality of electronic records.
    • And much more .

    SoftExpert Excellence Suite provides organizational efficiency, process control, and flexibility to help simplify the tasks involved in managing data and information. It will also help your organization make better decisions in managing the content and process that drive your business.

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Each SoftExpert component addresses key compliance issues as shown below:

Module FDA Compliance and Requirements
SE Document
SE Document
  • Manage the creation, review, approval, and distribution of documents.
  • Ensure changes to documents are reviewed and approved by authorized personnel.
  • Communicate approved changes to the appropriate personnel in a timely manner.
  • Document the Quality Management System.
  • Prevent unintended use of incorrect documents.
  • Automate document protection and retention rules.
  • Show enterprise-wide involvement in the process of document changes.
  • Remove or disable obsolete documents to prevent unintended use.
  • Ensure only the latest document versions are available for use.
  • Keep record of document change.
SE Audit
SE Audit
  • Streamline and effectively manage the audit process.
  • Provide advanced tracking capability.
  • Automate scheduling of all recurring audit-related activities.
  • Ensure the quality system is in compliance with the established quality system requirements and determine the effectiveness of the quality system.
  • Provide quality audit reports for management review.
  • Keep record of audit dates and results.
SE Process
SE Process
  • Streamline the entire change control procedure for faster turnaround.
  • Ensure production (and installation) processes are defined, planned, and documented.
  • Ensure processes are monitored and controlled.
SE Competence
SE Competence
  • Easily identify training needs.
  • Ensure that all activities are correctly performed by the right personnel.
  • Automate assignment and monitoring of training sessions.
  • Allow sequencing of training courses, so after a prerequisite is completed, the next course is automatically launched.
  • Provide group sign-off feature for verifying training of large groups of employees.
  • Keep record of all trainings carried out.
SE Calibration
SE Calibration
  • Ensure that all inspection, measuring, and test equipment are suitable for their intended purposes and are capable of producing valid results.
  • Check that equipment is routinely calibrated, inspected, checked, and maintained.
  • Ensure no unregistered or overdue equipment is used.
  • Assess measurement validity if found out of calibration.
  • Ensure measurement uncertainty and equipment capability are known.
  • Identify equipment which does not need to be calibrated.
  • Trace equipment measurements to national or international standards.
  • Document calibration steps for each piece of equipment.
  • Keep record of all calibrated equipment.
SE SPC
SE SPC
  • Verify acceptability of process capability and product characteristics.
  • Ensure that required characteristics of processes and products are monitored and measured.
  • Document procedures to implement and control the statistical techniques identified.
  • Identify variations in processes.
  • Ensure action plans are taken when out-of-control signals are detected.
  • Monitor the process for key constraints that correlate to final product quality.
  • Develop practices that ensure minimal variation.
  • Alert specified users when a process is trending out of control.
  • Provide closed-loop feedback to appropriate process controllers to bring the process back in control.
SE Inspection
SE Inspection
  • Maintain procedures for acceptance of incoming products.
  • Ensure incoming materials are inspected or verified as conforming to specified requirements.
  • Document acceptance or rejection of inspected material.
  • Ensure final inspection is performed prior to release of finished product.
  • Keep record of the results of supplier evaluations and follow-up actions.
SE Maintenance
SE Maintenance
  • Keep records of all maintenance work.
  • Ensure unique identification of each piece of equipment.
  • Keep records of equipment calibration and maintenance.
  • Document equipment instructions - usually supplied by the manufacturer.
  • Ensure equipment operates within specifications.
  • Provide maintenance schedule to ensure no equipment is overlooked.
SE Project
SE Project
  • Ensure projects are initially planned then approved.
  • Estimate initial project time, costs, and deliverables.
  • Identify, document, review, and approve all project changes and modifications.
  • Ensure critical path assessment.
  • Provide WBS & Milestone plan.
  • Keep record of all project meetings.
  • Ensure project tasks are performed and verified.
SE FMEA
SE FMEA
  • Maintain procedures to control the design of the device in order to ensure that specified design requirements are met.
  • Identify significant design or process characteristics that require special controls to prevent or detect failure modes.
  • Ensure the design output meets the design input requirements.
  • Ensure problems are prevented from occurring.
  • Maintain plans that describe or reference the design and development activities.
  • Define responsibility for implementing design plans.
  • Ensure plans are reviewed, updated, and approved as design and development evolves.
  • Keep record of all design reviews and verifications.
SE Risk
SE Risk
  • Provide qualitative and quantitative risk management.
  • Provide key risk indicators for tracking risk metrics and thresholds.
  • Automate the process of identifying, measuring, and monitoring operational risks.
  • Track material risks and quantify risk costs.
  • Enhanced visibility of the risks impacting the organization.
  • Provide statistical and trend analysis capabilities.
  • Keep record of risk history.
  • Provide an audit trail of actions taken and risk status.

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