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Scenario #1 - 21 CFR Subpart 11 (Electronic signatures) In accordance with 21 CFR Subpart 11, medical device manufacturers are required to have an electronic signature on predefined lifecycle state changes (promotions and demotions). The electronic signature requires the user (assume that they have the correct permissions to do so) to re-enter his/ her login & password information before the change can be made. Scenario #2 - DHF (Design History File) Each manufacturer is required to establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part. If organized in a central location, DHF can provide timely access to the information when needed. There are no requirements on the location or organization of the design history file. Scenario #3 - DMR (Device Master Record) All of the records required by the QS/GMP are to be maintained at the manufacturing facility or other location that is reasonably accessible to responsible officials of the manufacturer and employees of FDA designated to perform inspections. These records are to be made readily available for review and copying by FDA employees. These records must be legible, and stored in a manner that minimizes deterioration and loss. Automated record or document management systems shall be backed up. So what steps can be taken? Here is a process that IntegWare uses to help its customers ensure compliance. Based on the customer's requirements, we provide FDA compliance expertise, with regard to the scenarios above, necessary to validate the Customer's Product Lifecycle Management (PLM) environment. Due to the complex needs of medical device manufacturers, IntegWare supplies services to analyze our customer's current product development process. Once the applicable processes and operational factors are optimized, we develop a comprehensive analysis comprised of the customer's FDA needs. When necessary, IntegWare also develops software complimentary to the existing PLM system in order to validate that system for FDA compliance. The result is a comprehensive PLM system that can be accessed at any time for a complete audit of all product-related information. The value of this goes beyond being prepared for an FDA inspection; it is maximizing the efficiency of your PLM to better serve your design and manufacturing processes. In the end the steps you take toward compliance may make fewer steps in your product lifecycle. |
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