Failure to ensure that when computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol, as required by 21 CFR 820.70(i).
Your firm has not performed software validation [redacted]. These programs are used in the Starlight laser product family.
b. The software validation for [redacted] is inadequate, in that the [redacted]. This message occurs when either the maximum voltage (6V) is exceeded, or the actual voltage is higher than the reference voltage associated with the intensity selected by the operator.
Failure to validate computer software for its intended use according to an established protocol, when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70(i). For example, your firm has not validated the following software used in its quality system:
“Your software development / validation does not include written procedures, structural and regression testing, and code reviews.
Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). Specifically,
a. Your software development /validation:
does not include written procedures covering the development/validation of the software used in your devices
documentation for your Evolution Oxygen Conserver device does not include structural testing at the code level (use of static code checkers, independent code review, etc); and
software product testing procedure, Database/Software Controls IQP 030 Rev A dated 10/20/08, does not require structural testing and does not include provisions for the adequate description of regression testing.
….
c. The available clinical studies documentation for the following Evolution Oxygen Conservers:
did not include the written protocol or the patient’s baseline saturation levels for the 900M model; and
did not include the baseline saturation levels or the device settings for the patients.”
Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70(i).
When the FDA released the guidance for “Blood Establishment Computer Validation”, you probably logically thought it didn’t apply to you. While the focus of guidance is explicitly blood establishment computer systems, it represents the FDA’s current expectations for validation of high risk computer systems and includes some of the most explicit requirements released by the FDA for computer system validation. If you haven’t studied this document, you’ve missed a missed a thorough and pragmatic case study of FDA’s current expectations for computer validation of high impact computer systems. The guidance includes specific elements that should be included in validation procedures and cites specific methods and testing that should be performed on these systems.
What You Will Learn
Specific validation testing cited in the guidance
Practices that should be included in your validation procedures
System documentation your organization should be maintaining
Expected validation deliverable content, including validation plans, risk assessments and validation reports
For enterprise level projects, which validation activities can be performed for the entire organization and which activities must be performed at each site
Validation activities the FDA expects after system changes
On Wednesday, October 30 at 1:00pm EST, join FOI Servicesand Ofni Systemsfor a 90-minute teleconferenceto gain practical knowledge about this new computer system validation guidance, including a discussion of the testing, system documentation, validation and change control procedures that your organization needs to have implemented to ensure compliance.
About Ofni Systems
Ofni Systems is an industry leader for 21 CFR Part 11 compliance. Their products for Part 11 compliant databases and spreadsheets are used by pharmaceutical, biotech, and medical device companies across the globe, while it’s products for computer validation, auditing, and FDA submissions ensure that their clients meet every requirement for electronic records and electronic signatures. The company provides live desktop support for superior customer support and training and has been providing solutions to their clients since 1999. For more information, call (919) 844-2494 or visit www.OfniSystems.com.
Tyson Mew, president of Ofni Systems will be at IVT’s 18th Annual Validation Week in Philadelphia, PA on October 22-25. IVT has been in the forefront of promoting good validation practice for the last three decades. Today, new global regulations, technology advances and industry case models have shaped how to develop, implement and deploy validation procedures company-wide. Validation Week is a three-day event covering validation from A to Z, including; process, computer, equipment, method, facility, cleaning and much more. Ty Mew and Ofni Systems will be available throughout the conference to discuss validation methodology, demonstrate their validation automation tools and accept resumes from validation professionals.About Ofni Systems
Ofni Systems is an industry leader for 21 CFR Part 11/Annex 11 compliance and automating the validation process. Started in 1999, their products for compliant databases and spreadsheets are used by the FDA, pharmaceutical, biotech and medical device companies across the globe. They are the creators of ExcelSafe for Excel spreadsheet security and the Part 11 Toolkit for compliant databases. They also are the creators of the FastVal validation software for generating and executing validation documents, and have been providing professional validation services using FastVal since 2006. The company’s products for computer validation, auditing and FDA submissions ensure that their clients meet all requirements for electronic records and electronic signatures. Ofni Systems provides live desktop support for superior customer support and training. For more information, call (919) 844-2494 or visit www.OfniSystems.com.
Media Contact
Tyson Mew
President
Ofni Systems, Inc.
Phone: (919) 844 – 2494
Failure to validate the design under actual or simulated use conditions, as required by 21 CFR 820.30(g).
Failure to adequately document design inputs, as required by 21 CFR 820.30(c).
Failure to adequately document design outputs, as required by 21 CFR 820.30(d).
Failure to document process validation activities, as required by 21 CFR 820.75(a).
Failure to validate software used as part of production for its intended use according to an established protocol, as required by 21 CFR 820.70(i).
Failure to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
Failure to adequately establish procedures for corrective and preventive action; as required by 21 CFR 820.100(a).
Failure to adequately establish document control procedures, as required by 21 CFR 820.40. For example, your firm’s document control procedures, QOP-42-01) Control of Documents, Rev. D do not address how to control or identify [redacted]used to download the software in finished devices. These procedures do not have signature requirements that demonstrate documents, such as device history record documents· and design drawings have been approved. The documents are dated, and include the name of the individual approving the documents, but lack a signature. The software used to store the procedures, records and drawings do not have an electronic signature capability.
Tyson Mew, president of Ofni Systems, will speak at the 11th Annual Computer and Software Validation conference in San Diego, CA, from April 21 through April 23. IVT’s 11th annual event showcases the validation process for computer systems and software. Computer and software validation (CSV) has remained a FDA hot button over the last decade in the GXP environment (manufacturing, laboratory and clinical).
Mr. Mew gave two presentations:
Prepare for FDA CSV Inspections
Review of Recent Enforcement Actions, 483’s and Warning Letters
The FDA has been expanding their audit programs and the number of observations related to validation problems has been steadily increasing. New requirements for Risk Assessments have been appearing, as well as a number of observations related to change control This session will focus on what the agency is looking for in your validation program by reviewing recent 483’s and warning letters related to computer system validations. Key points that will be covered include:
Current FDA Requirements and Expectations for Validation
Review of recent 483’s and Warning letters
Consequences of Validation Gaps
A checklist of the top observations to avoid
Automate Your CSV Process
Templates, Tools, & Tricks
Automation can be an excellent technique to improve the overall quality of your validation processes while decreasing the time spend on each validation project. Ofni Systems is a leader in validation automation. Ty Mew, the president of Ofni Systems, will give you all of the information you need to begin to automate your computer validation process. Key points that will be covered include:
Getting Started – Preparing to Automate your CSV Practices
Discuss why CSV is well-suited to automation
Preparing templates for documents and certain types of systems
Determine and execute your testing strategy
Formalize your strategy in a Validation Master Plan
Implement best practices for lean project management
Automation of CSV Document Generation
Breaking down systems into discrete validatable objects
Collecting testable requirements
Automatically create your list of testable objects
Generating Design Specifications directly from source code
Integrating Risk Assessments into the process
Automatic generation, tracking and updating of the Requirements Traceability Matrix
Test Cases and Test Plans
How much testing is enough? Testing based on Risk Assessments
Input testing, Challenge Testing, Unit & Workflow test cases
Automating common test scripts with mini-test cases
Create specific test cases for use with change control
Auto-creation of test scripts from your requirements
Protocol Execution, Documentation and Managing Deviations
Paper vs. Electronic execution
Capturing actual results and screen shots for maximum effectiveness
Generating, processing and closing test and script deviations
Interactive Exercise: Case Studies of CSV Automation Success Stories
Several case studies will be presented to demonstrate how different types of validation projects were automated using the techniques described above. We will also discuss how the FDA is using automation for spreadsheet validation in their own labs.
Ty Mew was available throughout the conference to discuss computer validation. Ty wants to thank all of our friends who stopped by our booth during the conference and looks forward to working with you in the future.
Any parties who would be interested in having Mr. Mew speak on these topics relating to computer validation are encouraged to contact Ofni Systems.
About Ofni Systems
Ofni Systems is a leader in providing regulatory compliance solutions for pharmaceutical, biotech and medical device companies. They are the creators of ExcelSafe for Excel spreadsheet security and the Part 11 Toolkit for compliant databases. They also are the creators of the FastVal validation software for generating and executing validation documents, and have been providing professional validation servicesusing FastVal since 2006. Their products for Part 11 compliant databases and spreadsheets are used by pharmaceutical, biotech and medical device companies across the globe, while it’s products for computer validation, auditing and FDA submissions ensure that their clients meet every requirement for electronic records and electronic signatures.
Ofni Systems is also highly acclaimed for their expertise with 21 CFR Part 11 compliance. They are frequent speakers on Part 11 at conferences, meetings and webinars, and have provided training for thousands of employees to help implement the requirements. The company provides live desktop support for superior customer support and training, and has been providing solutions to their clients since 1999. For more information, call (919) 844-2494 or visit www.OfniSystems.com.
Media Contact
Tyson Mew
President
Ofni Systems, Inc.
Phone: (919) 844 – 2494
Raleigh North Carolina – Ofni Systems will be at the 25th SQA Annual Meeting, located at the Town and Country Resort and Convention Center in San Diego, California on April 19 – 24, 2009. Ofni Systems will have an information booth to inform SQA members about Ofni Systems compliance and validation services and products. Ty Mew will be available to answer questions about creating Part 11 compliant databases, Excel spreadsheet security and automating the validation process.
For more information about the 25th SQA Annual Meeting, please visit their website at www.SQA.org.
About Ofni Systems
Ofni Systems is a leader in providing regulatory compliance solutions for pharmaceutical, biotech and medical device companies. They are the creators of ExcelSafe for Excel spreadsheet security and the Part 11 Toolkit for compliant databases. They also are the creators of the FastVal validation software for generating and executing validation documents, and have been providing professional validation servicesusing FastVal since 2006. Their products for Part 11 compliant databases and spreadsheets are used by pharmaceutical, biotech and medical device companies across the globe, while it’s products for computer validation, auditing and FDA submissions ensure that their clients meet every requirement for electronic records and electronic signatures.
Ofni Systems is also highly acclaimed for their expertise with 21 CFR Part 11 compliance. They are frequent speakers on Part 11 at conferences, meetings and webinars, and have provided training for thousands of employees to help implement the requirements. The company provides live desktop support for superior customer support and training, and has been providing solutions to their clients since 1999. For more information, call (919) 844-2494 or visit www.OfniSystems.com.
Media Contact
Tyson Mew
President
Ofni Systems, Inc.
Phone: (919) 844 – 2494
