Learn how to write a (CSV) Computer System Validation Protocol according to the System Development Life Cycle (SDLC).
Either you create your own installation qualification or operational qualification protocol or use a template, they may include, but, is not limited to the following sections and information, (as applicable)
3.0 System Description.
5.0 Abbreviations and Definitions.
6.0 Documentation Requirements.
7.0 General Procedure.
7.1 General Description (Methodology)
7.2 System Architecture.
7.3 General Methodology.
7.4 Acceptance Criteria.
7.6 Training Record/Signature Log.
7.7 Test Instruments Calibration.
7.8 Supporting Documentation.
7.9 Final Report.
8.0 Installation Qualification.
8.1 IQ Test 1: Manuals and Documentation Verification.
8.2 IQ Test 2: Software Licensing Verification.
8.3 IQ Test 3: Equipment/System Component Verification.
8.4 IQ Test 4: Electrical Power Supply Utilities Verification.
8.5 IQ Test 5: Platform Software Installation Verification.
8.6 IQ Test 6: Controlled Procedure, Work Instruction & Specifications Verification.
8.7 IQ Test 7: System Minimum Requirements Verification.
8.8 IQ Test 8: Environmental Conditions Verification (Server Only)
8.9 IQ Test 9: Network and Communication Verification.
8.10 IQ Test 10: Equipment General Condition Verification.
8.11 IQ Test 11: IQ Completion Checklist.
9.0 Operational Qualification.
9.1 OQ Test 12: Standard Operating Procedures Verification.
9.2 OQ Test 13: Software and Application Version and Back-Up Verification
9.3 OQ Test 14: Power ON/OFF Verification
9.4 OQ Test 15: Interference Verification.
9.5 OQ Test 16: Communication Loss Verification.
9.6 OQ Test 17: System Response to Power Failure or Interruption.
9.7 OQ Test 18: Application Access Verification.
9.8 OQ Test 19: New User Creation Access Verification.
9.9 OQ Test 20: Concurrent User Verification.
9.10 OQ Test 21: Creating and Editing a User Account.
9.11 OQ Test 22: Sequence of Operation, and Audit trail Verification.
9.12 OQ Test 23: Reports Verifications.
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For more details on specific FDA expectations and how to perform a Computer System Validation protocol, follow us.
Three (3) Options to Create a Computer System Validation Protocol:
Option 1. You Can Create a CSV Protocol, using a Template.
You can download samples of the validation templates in .pdf format.
To see the complete list of the most popular validation templates, click here.
In addition, you can request a quotation to buy online a full validation template document in MS Word format that is completely editable, ready to fill and adapt to your needs.
Option 2. We Can Bring You a Formal Training on How to Perform Computer System Validation Using Our Template(s).
This option is recommended if you want to learn more about how to build a robust validation protocol. One of our expert(s) will provide online step-by-step training to your team (unlimited assistance) on how to build a reliable validation protocol using a template. You can improve your corporate validation procedures and policies incorporating our template sections. It includes the template, an exam, and a training certificate for each assistant. Request a quotenow.
Option 3. We Can Create a Customized Computer System Validation Protocol.
One of our expert(s) will create and prepare for you a customized validation protocol with the inputs and specific information of your company. It may include, online support in document creation, execution, or final reporting, Request a quote online.
The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems, GAMP 4 (ISPE/GAMP Forum, 2001) (http://www.ispe.org/gamp/)
ISO/IEC 17799:2000 (BS 7799:2000) Information technology – Code of practice for information security management (ISO/IEC, 2000)
ISO 14971:2002 Medical Devices- Application of risk management to medical devices (ISO, 2001)
Ramon Cayuela, MS, BS, Chemical Engineering
CIQA President and CEO.
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