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  1. Getting Started: The What, When & How of Creating a Manageable Validation Program

    Does that need validation, too?

    Creating an effective, comprehensive FDA-compliant computer validation program can appear overwhelming. In every corner there’s another computer system that just might need validating… it’s very tempting (and common) to conduct validations one-by-one as systems are uncovered by audits and inspections. The problem? This reactive approach almost guarantees that each inspection will reveal yet another system which requires validation, leaving your firm with a long trail of 483 observations, potential Warning Letters, or worse. Your costs will rise, your compliance profile and reputation will suffer.

    An efficient validation program clearly demonstrates your quality to your current and potential customers, reduces business and regulatory risks and actively supports the training and infrastructure you need to help your company thrive.

    You can get your computer systems under control, document your validation to FDA, and benefit from the resulting control…but where do you start?

    On Thursday, November 15 at 1:00 EST, join FOI as Ofni Systems of Ofni Systems presents a 90-minute teleconference offering practical advice for getting started on an efficient, effective computer validation program, including generating your computer system inventory, creating validation master plans, and outlining a validation methodology appropriate for your business.

    What You’ll Learn:

    • Which of your computer systems need to be validated…and which do not.
    • The documentation FDA investigators need to be sure your computer systems have been validated and are operating in a compliant manner.
    • The differences between validation, qualification, user acceptance testing and internal quality – and when each is appropriate.
    • Which regulations apply to your systems – and how you can document your compliance with those regulations.
    • Considerations for ensuring compliance with 21 CFR 11 and Annex 11.
    • What to ask suppliers when purchasing systems intended for GxP environments.
    • Industry best practices you can use to help maximize your validation resources.
    • How to involve system owners, users and quality in maintaining compliance.

    What You’ll Get:

    • Help in evaluating your computer systems to determine if validation is required.
    • An example of a Validation Master Plan and suggestions for tailoring it to suit your organization.
    • A checklist to help identify gaps in Part 11 compliance.
    • A look at a sample of a commercial program intended to help you manage validation activities.
    • An experienced, approachable instructor.
    • Time for questions and answers.

    Who Should Attend:

    • Managers and staff from FDA-regulated firms involved in validation activities from program design through quality control.
    • Anyone researching, selecting and purchasing computer systems that will be used in GxP environments.
    • Information technology professionals responsible for file administration or network locations storing databases containing GxP data.
    • Quality professionals responsible for designing, evaluating and verifying computer system compliance.
    • Executives developing strategic corporate plans and resource allocation.

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  2. Spreadsheet Validation 101 : Create and Validate FDA Compliant Spreadsheets

    Tags: |
    This page discusses a past conference.

    Click here to learn more about spreadsheet validation.

     

    Tyson Mew, President of Ofni Systems, and Ofni Systems, Validation Manager for Ofni Systems will speak at IVT’s 12th Annual Computer and Software Validation conference in Philadelphia, PA, from April 26 through April 28. Ty and Daniel will present Spreadsheet Validation 101 : Create and Validation FDA Compliant Spreadsheets on Wednesday, April 27 at 8:45 AM – 12:15 PM.

    Easy-to-create and surprisingly powerful and flexible tools for data storage, spreadsheets are so common that they can almost seem invisible. However, GxP data stored within spreadsheets must be maintained in accordance with all applicable regulatory rules, especially 21 CFR 11; Electronic Records Electronic Signatures. The FDA is aware of the usefulness of spreadsheets, but expects controls to be in place to ensure that spreadsheets used in GxP processes are compliant with 21 CFR 11 and are validated. As FDA enforcement of 21 CFR 11 increases, uncontrolled spreadsheets represent an area of increased regulatory concern.

    IVT’s 12th 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). Whether working in traditional pharmaceuticals, emerging biotechnology or the medical device industry, participants take away cutting edge information that can be immediately implemented.

    Ty Mew and Ofni Systems will be available throughout the conference to discuss validation.

    Spreadsheet Validation 101 : Create and Validation FDA Compliant Spreadsheets will cover:

    Spreadsheets in GxP Environments

    • How the FDA validates their spreadsheets
    • Scale validation to spreadsheet functionality
    • Required spreadsheet validation documents
    • Design spreadsheets that facilitate compliance
    • Requirements for compliance with 21 CFR 11

    Writing Spreadsheet Functional and Design Requirements

    • Write requirements that facilitate testing and detect common deviations
    • Document Data Entry, Formulas and Calculations
    • Documenting Macros

    Test Protocols for Spreadsheets

    • Focused testing
    • Test spreadsheet inputs, outputs and compliance

    Interactive Exercise – Validating a Spreadsheet

    Participants examine a spreadsheet, determine the requirements for the spreadsheet and then create a suitable test case which verifies that the requirement has been implemented successfully. Participants are encouraged to bring their own example spreadsheets.

    Bonus Materials

    All conference participents will receive:

    • A checklist to determine if spreadsheets are compliant with 21 CFR 11
    • Sample spreadsheet validation package
    • Whitepaper — “MS Excel Spreadsheet Validation”
    • A trial copy of ExcelSafe that provides audit trails, password protection, user-level security and electronic signatures

    About the Presentors

    Tyson M. Mew is President of Ofni Systems, a software provider and Part 11 consulting firm. He has a strong background in software development and computer system validation, and has spoken at many conferences and workshops on Part 11. He is the creator of ExcelSafe and has worked on hundreds of client spreadsheets and desktop database systems to make them compliant. Mr. Mew regularly conducts training sessions for organizations to educate employees about the specific requirements of the rule and how to incorporate it into daily practices. He is an active member of ISPE, DIA, PDA, SQA and the PEERS Group.

    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.


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  3. IVT Computer and Software Validation EU Press Release

    Tags: |

    Raleigh North Carolina – Tyson Mew, president of Ofni Systems, will speak at the Computer and Software Validation EU conference in Dublin, Ireland from September 27 through September 29. The 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). Today, new approaches, such as EU’s Annex 11 and ASTM 2500, have taken the forefront in assisting organizations with CSV compliance. In this ‘create-your-own conference’ format, attendees build their own event to suit their specific validation needs, Whether working in traditional pharmaceuticals, emerging biotechnology or the medical device industry, participants take away leading edge information that can be immediately implemented.

    Ofni Systems is sponsor of the conference. Ty Mew and Ofni Systems will also be available throughout the conference to discuss computer validation.

    About Ofni Systems

    Registration information for the 11th Annual Computer and Software Validation conference is available.

    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


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  4. Ofni Systems Exhibit at the SQA 26th Annual Meeting, April 26-28 2010

    Tags:

    Ofni Systems exhibited their software and services at the SQA 26th Annual Meeting in Cincinnati, OH. Ofni Systems informed SQA members about Ofni Systems compliance and validation services and products. In addition, Ty Mew, the president of Ofni Systems, was available to answer questions about creating Part 11 compliant databases, Excel spreadsheet security and automating the validation process.

    Ty Mew 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 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


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  5. Ofni Systems Presentation at IVT’s 11th Annual Computer and Software Validation

    Tags: |

    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


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  6. Get Started on your 2010 Validation Commitments

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    It’s a new year! Its time to prepare for regulatory and supplier compliance audits. But everyone in your department is already fully tasked and no one really has the appropriate validation experience. The FDA requires validation to document that GxP processes, computer systems, equipment and cleaning protocols are in compliance with all requirements. Failure to validate systems is one of the leading reasons a business is issued a 483.

    Contact Ofni Systems and meet your Commitments

    • Computer System Validation Ofni Systems will validate all of your software, databases, spreadsheets and computer systems and develop the appropriate documentation for all phases of the software life cycle.
    • Process and Equipment Validation Ofni Systems will identify and describe your GxP processes and equipment, document and execute superior test protocols designed to demonstrate that your process meets all of your business and compliance requirements
    • Cleaning Validation Ofni Systems will document and test the most appropriate testing methodology for your business and regulatory needs.

    Validation experts working for you

    Validation should add value to your computer system or process. Ofni Systems will analyze your systems, identify the highest risk sections and focus testing appropriately. Our specialists are experts in industry standards and practices and will produce validation documents which will meet or exceed your exacting requirements.

    Ofni Systems uses FastVal to execute Testing Protocols and focus testing, which allows us to complete higher quality validation projects with in 70% less time and with less cost than traditional validation methods.

    Contact Ofni Systems and find out how our validation specialists can validate your computer system, equipment or process within your time and financial requirements.


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  7. 21 CFR Part 11 Compliance and Validation for Databases and Spreadsheets

    Tags: |

    The Executive Conference Corporation will present an e‑conference on 21 CFR Part 11 Compliance and Validation for Databases and Spreadsheets on December 17, 2009 from Noon to 1:30 pm ET. The e‑conference will be presented by Mr. Tyson Mew.

    This conference has already occurred. Please contact Ofni Systems if you would be interested in setting up your own training session on 21 CFR Part 11 Compliance and Validation for databases and spreadsheets.

    Learn to Make Your Databases Compliant

    Hundreds of 483’s and warning letters are received each year by companies who did not design or validate their databases and spreadsheets to meet Part 11 requirements.

    In this webinar you will learn how to implement Part 11 requirements in databases (Access, Oracle, and SQL Server) and Excel spreadsheets. This presentation will provide the instructions, and documentation to ensure full compliance with 21 CFR Part 11, including:

    • Strategies for how to document and validate Access databases and other software applications based on databases.
    • How to add audit trails to databases and spreadsheets
    • How to define requirements quickly.
    • Managing change control and common change control mistakes to avoid.
    • How to document inputs, code and security settings.
    • How to properly secure the data and code.
    • Access security settings for multiple users.
    • Common settings applied to limit user actions.
    • Details on when and where to use electronic signatures.
    • Advanced techniques for adding electronic signatures
    • Inactivity timeouts, and controls for users and passwords.
    • Tips for efficient database testing.
    • Learn about how the FDA secures their own databases and spreadsheets

    About Tyson Mew

    Tyson M. Mew is President of Ofni Systems, Inc., a software provider and Part 11 consulting firm. He has a strong background in software development and computer system validation, and has spoken at many conferences, webinars, audio conferences and workshops on FDA requirements for electronic records and signatures. Ty regularly conducts training sessions for organizations to educate employees about the specific requirements of 21 CFR Part 11 and Computer Systems Validation. He is an active member of ISPE, DIA, SQA and the Triangle PEERS group.

    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 Document Generator software for generating and executing validation documents, and have been providing professional validation services using FastVal since 2006.

    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. For more information, contact Ofni Systems at (919) 844-2494, via email at Info@OfniSystems.com, or by visiting www.OfniSystems.com.


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  8. Celebrating 10 Years of Quality and Compliance Services

    Ofni Systems wants to thank all of our clients for 10 years of quality consulting and compliance software. Ofni Systems was founded in 1999, dedicated to helping companies address the opportunities present in 21 CFR Part 11, Electronic Records and Electronic Signatures. Ofni Systems has been fortunate to have the opportunity to work with some of the best companies in the pharmaceutical, medical devices, clinical research fields. FDA regulated industries, including pharmaceuticals, bioscience, medical devices and clinical trials, utilize Ofni Systems’ proven software and consulting to become compliant with 21 CFR Part 11 and add value to their business processes.

    Leaders in Validation and Compliance Services

    In ten years, Ofni Systems has become 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 services using FastVal since 2006.

    Ofni Systems products for Part 11 compliant databases and spreadsheets are used by pharmaceutical, biotech and medical device companies across the globe and Ofni Systems products for computer validation, auditing and FDA submissions ensure that clients meet every requirement for electronic records and electronic signatures.


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  9. ExcelSafe V2.1 Press Release

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    Raleigh North Carolina – Ofni Systems announces ExcelSafeTM, version 2.1, which provides MS Excel with password protection, user level security, audit trails and electronic signatures. “ExcelSafe is an excellent tool for regulated industry. It provides the technological tools to make MS Excel compliant with 21 CFR Part 11,” said Ofni Systems President Tyson Mew. “ExcelSafe is spreadsheet security made simple.”

    ExcelSafeTM provides users of Microsoft Excel with

    • User Security – Entry into spreadsheets requires a user name and password. ExcelSafeTM has configurable user-level security which can restrict which users can open or spreadsheets and apply or remove electronic signatures.
    • Data Security – All changes to Excel are automatically recorded. The audit trail records the previous and new value of a cell, the date/time of a change, the user making the change and the reason data was changed. The audit trail also records other spreadsheet events, including addition or deletion of a worksheet. Electronic signatures prevent changes within a worksheet. Even deleted records are preserved on an unalterable audit trail.
    • Traceability – ExcelSafeTM comes with tools to track all changes to spreadsheets. Users can query results from any spreadsheet.
    • Simplicity – ExcelSafeTM works automatically with existing spreadsheets and templates. Once a spreadsheet is opened in ExcelSafeTM, all compliance tools work automatically. Users operate Excel normally; there is no complicated interface to learn. ExcelSafeTM supports any number of users and any number of spreadsheets.

    Version 2.1 includes additional tools for users to classify spreadsheets, improved compatibility with Excel 2007 file formats and for system administrators to facilitate the use of ExcelSafe across networks. ExcelSafe can be configured to use either an Oracle or a SQL Server for data storage.

    More information about ExcelSafe is available at www.OfniSystems.com/ExcelSafe.

    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.

    Media Contact
    Tyson Mew
    President
    Ofni Systems, Inc.
    Phone: (919) 844 – 2494


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  10. How to Validate Device and Computer Software

    Tags: |

    Computer software validation has been a major issue for medical device manufacturers and is one of the leading causes of 483 observations, warning letters and product recalls. There are many different types of computer hardware and software found in the medical device industry, including:

    • COTS (Commercial Off-The-Shelf) applications
    • Custom in-house applications (databases and spreadsheets, web apps, etc)
    • Software embedded in medical devices
    • Software used to create or manufacture devices

    All of the above must be validated for intended use and be under strict change control.  The risk to patients can be severe for even small software bugs, and the cost of legal actions or product recalls can be financially devastating. The following topics will be covered in detail:

    • A review of recent enforcement actions as a result of inappropriate computer system validations.
    • The basics of computer software validation and what is expected in any validation effort.
    • A presentation of Ofni System’s methodology for how we create functional requirements, design specifications and test cases.
    • Education for users about specific hot spots, including Change Control and Risk Assessments.
    • A discussion of new technologies for automated testing and electronic protocol execution.

    e-Conference, Presented by the Clinical Device Group


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