Validation of a CMS Software
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1 Validation of a CMS Software GxP Webinar Paul Daniel Senior Regulatory Compliance Instructor Vaisala, Inc.
2 Practical Webinar Stuff Challenges with your audio connection? Try calling by phone: U.S. & Canada Toll-Free (877) International Toll (949) Other technical challenges? Try logging in to webinar again. Participate by: Answering poll questions. Ask questions using Chat function. You will receive a link to the presentation in . Page 2 / GAMP Validation of Your CMS Webinar / Vaisala
3 Vaisala in Brief We serve customers in weather and controlled environment markets 75 years of experience in providing a comprehensive range of innovative observation and measurement products and services Page 3 / GAMP Validation of Your CMS Webinar / Vaisala
4 Vaisala - Life Science Our Offering Provides measurement instrumentation, continuous monitoring systems and validation systems for regulated or highly controlled life science environments. Our Goal is to help customers Reduce their risk of lost or adulterated product Reduce their risk of failing to meet GxP regulations and/or guidelines Page 4 / GAMP Validation of Your CMS Webinar / Vaisala
5 Your Hosts Speaker: Paul Daniel Sr. Regulatory Expert Chat Moderator: Janice Livingston Marketing Specialist Page 5 / GAMP Validation of Your CMS Webinar / Vaisala
6 What are you most interested to learn from this webinar? A. Better understanding of GAMPstyle validation B. How to identify gaps in my current validation program C. Recommendations for documents such as URS, FS and Traceability Matrices D. Learn more about Vaisala products in general E. I forgot I only joined because an made me click it F. Other Page 6 / GAMP Validation of Your CMS Webinar / Vaisala
7 What industry do you work in? A. Pharmaceuticals B. Medical Devices C. Biologics, HCT/ps or Blood/Tissue D. Contract Organization E. Nutraceuticals F. Consulting or engineering firm G. Distribution/Logistics H. Student I. Manufacturing other than Life Science J. Industry other than Life Science Page 7 / GAMP Validation of Your CMS Webinar / Vaisala
8 Have you attended a Vaisala webinar before? A. No B. Yes C. Not sure, it s all a blur Page 8 / GAMP Validation of Your CMS Webinar / Vaisala
9 Validation of a CMS Software Using GAMP principles in monitoring system validation
10 Goal of this Webinar Review the GAMP process for CMS validation. Break it into easy to understand steps. Page 10 / GAMP Validation of Your CMS Webinar / Vaisala
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18 What brand of automobile do you own? A. Toyota B. Honda C. Ford D. Chevy E. BMW F. VW G. Other H. Don t Know 12% 12% 12% 12% 12% 12% 12% 12% Toyota Honda Ford Chevy BMW V W Other Don t Know Page 18 / GAMP Validation of Your CMS Webinar / Vaisala
19 What brand names do you recognize? A. Toyota B. Honda C. Ford D. Chevy E. BMW F. VW G. None 14% 14% 14% 14% 14% 14% 14% Toyota Honda Ford Chevy BMW V W None Page 19 / GAMP Validation of Your CMS Webinar / Vaisala
20 Do you know what car you would buy? A. Yes B. No 50% 50% Yes No Page 20 / GAMP Validation of Your CMS Webinar / Vaisala
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25 Step 1: Requirements Describes what system needs to do. -or- Identify stakeholder needs to create consensus and guide system selection. Most important step in entire process!!! Page 25 / GAMP Validation of Your CMS Webinar / Vaisala
26 The Quality System Puzzle Page 26 / GAMP Validation of Your CMS Webinar / Vaisala
27 URS What does it look like? Standard Approved Document What makes it different? System Description Requirements Sensors Network Utilities Infrastructure Security Alarming Reporting IT????? Page 27 / GAMP Validation of Your CMS Webinar / Vaisala
28 Sample Requirement Page 28 / GAMP Validation of Your CMS Webinar / Vaisala
29 Make your Requirements SMART Page 29 / GAMP Validation of Your CMS Webinar / Vaisala
30 Other Sample Requirements Alarming The system must have the capability to notify facility personnel when sensor readings exceed threshold values. have configurable delays from 0 to 60 minutes before alarm generation and notification. allow multiple high and low thresholds. communicate alarm states by SMS text, , and phone. Page 30 / GAMP Validation of Your CMS Webinar / Vaisala
31 Approval of the URS by stakeholders Developed by Committee Easy to approve if stakeholders are included. Expect some rounds of revision. You will have more requirements than you can meet. Retain unsatisfied requirements for traceability and transparency of work-arounds. System selection will be a compromise. Page 31 / GAMP Validation of Your CMS Webinar / Vaisala
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34 Step 2: Begin Trace Matrix Traceability Matrix (TM) Simple table to track our requirements. There is a function that fulfills each requirement. Each function is tested. Just a spreadsheet, populated with the requirements. Start it now, so that can be used as a tool!!! Page 34 / GAMP Validation of Your CMS Webinar / Vaisala
35 Trace Matrix Example Page 35 / GAMP Validation of Your CMS Webinar / Vaisala
36 Finding a System Not like a car don t know what is out there Influential Persons Web Searches Existing Relationships Other Constraints Acquisition Budget Long-Term Cost of Ownership Validation Capabilities Page 36 / GAMP Validation of Your CMS Webinar / Vaisala
37 Step 3: Select a System Audit the Vendors (2 ways!) Quality System CMS Solution Compare your requirements to the candidate systems. Goal Identify multiple candidate systems for further examination. Page 37 / GAMP Validation of Your CMS Webinar / Vaisala
38 Step Category Name 3 Off-the-Shelf 4 Configured 5 Custom Page 38 / GAMP Validation of Your CMS Webinar / Vaisala
39 Category 3: Off-the-Shelf GAMP 4 - Standard Software GAMP 5 - Non-configured There are important distinctions for other types of software, but for CMS, we know it will be software on a server with a sensor network. KEY: Run-time configuration ONLY. No additional configuration! Page 39 / GAMP Validation of Your CMS Webinar / Vaisala
40 Category 4: Configured GAMP 4 - Configured Software GAMP 5 - Configured Products These products don t do what you want out of the box. Parameters must be set to match your business process. KEY: Any configuration beyond run-time. But, no custom code, even when constructed using the application itself. Page 40 / GAMP Validation of Your CMS Webinar / Vaisala
41 Category 5: Custom GAMP 4 - Custom Software GAMP 5 - Custom Products These products are made bespoke for your business process. They did not exist before, and were not tested. KEY: This includes code created using the functions within an application that is not custom, such as Macro functions in Excel. Page 41 / GAMP Validation of Your CMS Webinar / Vaisala
42 For our purposes Category Name 3 Off-the-Shelf 4 Configured 5 Custom Page 42 / GAMP Validation of Your CMS Webinar / Vaisala
43 Step Describes the system functions. Describes how the system will fulfill the requirements. FS should be detailed, and may be available from vendors. FS may be vague, as system doesn t exist. Note: Use FS for system selection by comparing to URS. Page 43 / GAMP Validation of Your CMS Webinar / Vaisala
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45 Sample Functions - WILL Alarming The system will notify facility personnel when sensor readings exceed threshold values. allows configurable delays from 0 to 60 minutes before alarm generation and notification. allows multiple high and low thresholds. communicates alarm states by SMS text, , and phone. Page 45 / GAMP Validation of Your CMS Webinar / Vaisala
46 Trace Matrix Example (cont d) Page 46 / GAMP Validation of Your CMS Webinar / Vaisala
47 Thoughts so far There won t be 1:1 correlation from URS and FS. Populate the TM to see if requirements are met. Some requirements will not be met. Not all requirements are created equal. We should be ready to make our final system selection. Page 47 / GAMP Validation of Your CMS Webinar / Vaisala
48 The Road not Taken The system type you choose will have a large impact on the required validation effort, and on the return on your investment. Page 48 / GAMP Validation of Your CMS Webinar / Vaisala
49 Step Not necessary. System already in final form. Configuration Specification (CS) Describes the configuration necessary to match the system functions to the business process. Detailed Design Specification (DDS) How the system will be designed. It still needs to be built. Note: DDS is out of scope for this presentation. Page 49 / GAMP Validation of Your CMS Webinar / Vaisala
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51 Other Sample Configurations Alarming For refrigerator Alert alarms, the delay before activation is set at 5 minutes; Action alarms have a delay before activation set at 30 minutes. Refrigerator alarms are set at Alert levels of 3 and 7ºC and Action levels of 2 and 8ºC. For refrigerators, Alert alarm notifications are sent by text to the Lab Manager ( ), and Action alarm notifications by to QA (john.doe@vaisala.com). Page 51 / GAMP Validation of Your CMS Webinar / Vaisala
52 Trace Matrix Example (cont d) Page 52 / GAMP Validation of Your CMS Webinar / Vaisala
53 Step Goal Necessary for all system types. Testing required increases GEOMETRICALLY with system complexity. Make sure every GMP item identified in URS/FS/CS is tested. Use risk assessment activities to lighten the load. This is where SMART requirements pay-off. Use TM to ensure all items are tested. Page 53 / GAMP Validation of Your CMS Webinar / Vaisala
54 Trace Matrix Example (cont d) Page 54 / GAMP Validation of Your CMS Webinar / Vaisala
55 What kinds of testing? Code Review Module Testing FAT Commissioning SAT IQ OQ PQ Page 55 / GAMP Validation of Your CMS Webinar / Vaisala
56 What kinds of testing? Code Review Module Testing FAT Commissioning SAT IQ OQ PQ Page 56 / GAMP Validation of Your CMS Webinar / Vaisala
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58 Step 8: Finalize Trace Matrix We have been adding to this all along URS, FS, CS, Test Documents Verify each item is tested. There may be tests with no requirement.. Do we need the test? There may be requirements with no test Justification or rationale to not test. Final check. All docs approved, entered in TM. TM checks out. Page 58 / GAMP Validation of Your CMS Webinar / Vaisala
59 Step 9: Perform Testing The hard work is done. This is the fun part! Real life doesn t follow the plans. There will be deviations. Most of them will be resolved. If something just doesn t work.. Revise the requirement. Develop a work-around. Get a fix from vendor. Page 59 / GAMP Validation of Your CMS Webinar / Vaisala
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61 Step 10: Maintain System SOPs Training Calibration Validation Change Control Page 61 / GAMP Validation of Your CMS Webinar / Vaisala
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66 Summary of this Webinar Review the GAMP process for CMS validation. Break it into easy to understand steps. Page 66 / GAMP Validation of Your CMS Webinar / Vaisala
67 Check us out The blog is a great place to post questions and get feedback from our experts and industry contacts. Page 67 / GAMP Validation of Your CMS Webinar / Vaisala
68 Want more information? Would you like to speak with a Vaisala Application Engineer about a Vaisala product? A. Yes Continuous Monitoring System B. Yes Mapping/Validation System C. Yes Data loggers D. Yes Process Instrumentation E. Yes Handheld devices F. Yes Other G. Not at this time Page 68 / GAMP Validation of Your CMS Webinar / Vaisala
69 Thanks for Attending! Paul Daniel Senior Regulatory Compliance Instructor Vaisala, Inc. Page 69 / GAMP Validation of Your CMS Webinar / Vaisala
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