Regulatory Open Forum

 View Only

  • 1.  Production Software Validation Standards

    Posted 23-Sep-2016 12:00

    ISO 13485:2016 has four areas that include non-device software and its validation: QMS software, software as an infrastructure element, production & service software, and monitoring & measuring software. This will raise greater focus on validation of this type of software.

    Can anybody point me to software validation standards or great reference books? I’m not interested in validation of software that goes into a device, but production software in particular. I recognize there will be some overlap of methods, but I have a more narrow focus.

    ------------------------------
    Dan O'Leary
    Swanzey NH
    United States
    ------------------------------


  • 2.  RE: Production Software Validation Standards

    Posted 23-Sep-2016 12:43
    Hi Dan,

    I refer everyone to AAMI TIR-36:2007, Validation of software for regulated processes.  I've copied the Abstract for you, so that you can decide if this fits with your needs:

    Abstract:  Applies to any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, and complaint handling or to automate any other aspect of the quality system as defined by the Quality System Regulation (21 CFR 820). In addition, it applies to software used to create, modify, and maintain electronic records and to manage electronic signatures that are subject to the validation requirements (21 CFR 11). This TIR can also be broadly applied wherever software automates processes regulated by the FDA. This TIR applies to software used in the production of a device and to software used in implementation of the device manufacturer's quality system. It does not apply to software used as a component, part, or accessory of a medical device or software that is itself a medical device.

    Regards,

    John



    Original Message


  • 3.  RE: Production Software Validation Standards

    Posted 24-Sep-2016 05:47

    John,

    Thank you for the response. Based on the abstract, it is exactly what I was looking for. I look forwarding to getting a copy and reading it.

    ------------------------------
    Dan O'Leary
    Swanzey NH
    United States

    Original Message


  • 4.  RE: Production Software Validation Standards

    Posted 26-Sep-2016 03:34

    Dear Dan

    As a consultant but also as a Lead Auditor for a Notified Body I usually recommend using GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (http://www.ispe.org/gamp-5).

    Abstract:

    GAMP® 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. This technical document describes a flexible risk-based approach to compliant GxP regulated computerized systems, based on scalable specification and verification. It points to the future of computer systems compliance by centering on principles behind major industry developments such as PQLI; ICH Q8, Q9, Q10; and ASTM E2500.

    This revolutionary Guide addresses the entire lifecycle of an automated system and its applicability to a wide range of information systems, lab equipment, integrated manufacturing systems, and IT infrastructures. It contains new information on outsourcing, electronic batch recording, end user applications (such as spreadsheets and small database applications), and patch Management.

    I have to admit that I don't know AAMI TIR-36:2007 (mentioned by John) and therefore can't provide a comparison. What I like about GAMP5 is the risk-based approach (5 categories) that allows you to implement different approaches and give good guidance regarding off-the-shelf products vs. complex newly developed systems.

    Cheers, Beat

    ------------------------------
    Beat U. Steffen
    Founder & CEO
    confinis ag
    Duedingen
    Switzerland

    Original Message


  • 5.  RE: Production Software Validation Standards

    Posted 26-Sep-2016 14:48

    I'll second John's and Beat's recommendations of AAMI TIR-36 and GAMP5.

    And, though basic and provided in the context of FDA, don't forget about Section 6 of FDA's guidance document on general principles of software validation.  Here's a link:

    http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085281.htm

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com

    Original Message


  • 6.  RE: Production Software Validation Standards

    Posted 29-Sep-2016 07:57

    Thank for the valuable suggestions. I look forward to understanding the documents.

    I do have the FDA guidance and used it. While it is good, it isn't specific enough for my current project. I also suspect that "the state of the art" has moved since the publication.

    ------------------------------
    Dan O'Leary
    Swanzey NH
    United States

    Original Message


  • 7.  RE: Production Software Validation Standards

    Posted 29-Sep-2016 08:15
    Dan,

    I understand you are working on non-medical device software project.

    General principles on software apply.

    It should be noted that the approaches on verification and validation should be differentiated due to significant differences in user requirements. 

    Accordingly, references offered should be evaluated on a case by case to determine whether it is relevant and applicable to your project based on potential risks and technical rationale. 

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.



    Original Message


Related Content