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  1. KF Comm from Spectrum Laboratories uses ExcelSafe

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    KF Comm for ExcelSafe

     

    SpectrumLabs.com is a leader in the manufacture and supply of single-use hollow fiber filtration modules and tangential flow filtration systems for the Diagnostic, Bioprocessing and Pharmaceutical Industries. In addition to the largest selection of single-use hollow fiber filters, Spectrum’s KrosFlo® process filtration products include filtration systems for tangential flow filtration and bioreactor perfusion.

    SpectrumLabs’s KF Comm is a software program that allows users to collect real-time data from the KR2i or KMPi pumps and auxiliary components (optional scales, pumps, and valves) in a Microsoft® Excel® spreadsheet.

    The software records 12 real-time operating parameters:

    • Time
    • Inlet Pressure
    • Retentate Pressure
    • Permeate Pressure
    • Feed Flow Rate
    • Pump RPM
    • Pump Mode (7 different Pump modes)
    • Permeate Flow Rate (with optional auxiliary pump)
    • Notes (Alarm, Process Status, Functions)
    • Diafiltration Flow Rate ( with optional auxiliary pump)
    • Feed Scale Weight ( with optional auxiliary scale)
    • Permeate Scale Weight ( with optional auxiliary pump)
      The software Calculates 8 parameters:
    • Transmembrane Pressure (TMP)
    • Permeate Flow Rate (with no optional auxiliary pump)
    • Retentate Flow Rate (with no optional auxiliary pump)
    • Flux
    • Pressure Drop (ΔP)
    • Volumetric Throughput (VT)
    • Concentration Factor
    • Shear

    All process parameters are recorded at user-defined intervals eliminating the need for manual recording. In doing so, KF Comm enables quick analysis using Excel graphs and facilitates optimization, scale-up and process documentation. SpectrumLabs.com uses ExcelSafe™ to provide compliance with 21 CFR11 in the KF Comm software.

    ExcelSafe is available for the following versions of KF Comm software;

    • KMPi: Process Controls and Data Collection Software for Pilot-scale Bioprocessing (more info)
    • KR2i: Data Collection Software for R&D Scale Bioprocessing (more info)

    Pricing Information

    For KF Comm to be 21 CFR Part 11 Compliant it needs to be used with a KF Comm Compliant Workbook and interface with the Ofni Systems’ ExcelSafe™ software package.

        • The price for a KF Comm validation package bundled with ExcelSafe is $10,995.

    We also can provide a complete validation package for KF Comm. Each validation package includes a Functional Specification, Design Specification and Installation/Operational Test Protocol. The validation package also includes an example execution of the test protocol and a Validation Summary Report. There is also a separate validation package for ExcelSafe.

        • Validation Package for both KF Comm Software and ExcelSafe: $5,995
        • Validation Package for KF Comm Software only: $2,495 each

    Contact Ofni Systems or Spectrum Labs for more information about ExcelSafe or the KF Comm software.


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  2. IVT’s 2nd Annual Data Integrity Validation Conference

    August 17-18, 2016 Royal Sonesta Boston at Cambridge, MA

    Join us for IVT’s 2nd Annual Data Integrity Validation Conference to analyze the effects of FDA’s Data Integrity and Compliance with cGMP Draft Guidance released in April 2016 and implement enterprise-wide solutions.

    Don’t miss Ofni Systems’ President, Ty Mew speak on Auditing the Audit Trails – Key Elements to Define and Track your Data.

    Registration information for the 2nd Annual Data Integrity Validation Conference is available here.


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  3. IVT’s 17th Annual Computer and Software Validation

    April 26-28, 2016 Hilton at Penn’s Landing Philadelphia, PA

    Join us for the IVT’s 17th Annual Computer and Software Validation to ensure you implement the most current, compliant procedural trends in an ever-changing technology environment.

    Are you up-to-date with the most current CSV regulations and processes?

    With the strong regulatory focus from FDA and all other global authorities on data integrity, mobile medical devices, software apps, and cloud computing, it has never been more critical to understand up-to-the-minute regulations, trends and procedures involved with implementing CSV enterprise-wide.

    This is industry’s “must-attend” event for CSV validation, IT, engineering and QA professionals who are responsible for implementing and maintaining a best-in-class program.

    Write Better! Best Practices in Writing Specs and Test Protocols

    Registration information for the 17th Annual Computer and Software Validation conference is available .


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  4. Validation & GMP Week

    March 15-16, 2016 Sheraton Old San Juan Hotel, San Juan, Puerto Rico

    IVT’s Validation and GMP Week heads back to Puerto Rico! Join us to hear the latest regulatory updates and learn how to implement the best-in-class processes enterprise-wide.

    There is more going on in the validation and GMP environments than ever before. It has never been more critical to understand current regulations, trends and procedures such as statistics in validation, validating data and quality metrics. This conference covers the implementation procedures for equipment, utilities, cleaning, computer systems, analytical procedures, as well as other critical GMP topics such as change control, risk management and corrective action, enterprise-wide. Non-compliance and poor validation and GMP processes cost patient safety and efficacy, product time-to-market, personnel time and millions in fines and revenue. This is an event you don’t want to miss!

    Registration information for Validation & GMP Week is available .


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  5. 4th Global QA Conference & 30th SQA Annual Meeting

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    Tyson Mew, president of Ofni Systems, will be at the 4th Global QA Conference & 30th SQA Annual Meeting in Las Vegas, NV, from April 6–11, 2014. Ty will be demonstrating how ExcelSafe gives your analytical spreadsheets the controls and security features needed for 21 CFR Part 11 compliance.

    Learn how to Create and Validate Spreadsheets in FDA-Regulated Environments

    Easy-to-create and surprisingly powerful and flexible tools for data storage and processing, spreadsheets are so common that they can almost seem invisible. However, GxP data stored or processed with spreadsheets must be maintained in accordance with all applicable regulatory requirements, especially 21 CFR 11, Electronic Records Electronic Signatures. The FDA is aware of the usefulness of spreadsheets but expects controls to be in place that ensure 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 QA concern.

    Society of Quality Assurance

    SQA’s 4th Global QA Conference & 30th Annual Meeting is a six-day conference for discussion of emerging trends and issues affecting Quality Assurance practices in regulated industry. Hot topics include Computer Validation, Scientific Archiving, Industry Best-Practices, and Compliance. The conference will feature a number of industry expert talks and opportunities for knowledge exchange among QA peers from around the globe.

    Ty Mew and Ofni Systems will be available throughout the conference to discuss spreadsheet and software compliance and validation.
    Registration information for the 14th Annual Computer and Software Validation conference is available .


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  6. ExcelSafe to Offer Integration with Sharepoint and Agilent Platforms

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    Raleigh North Carolina – Ofni Systems announces that the upcoming release of their ExcelSafe Spreadsheet compliance software application will offer support for enterprise-level document management systems including Microsoft Sharepoint and the Agilent OpenLab Enterprise Content Manager (ECM).

    “This is a giant step forward for the ExcelSafe application,” stated Ty Mew, President of Ofni Systems. “The next version will be a drop-in-place solution for both existing and new ExcelSafe customers that will offer the security, convenience, and document protection of a check-out/check-in module. Users can now travel with their spreadsheets while still maintaining full FDA 21 CFR Part 11 compliance.”

    The ExcelSafe software has been used at the FDA and by hundreds of pharmaceutical, medical device, and clinical companies to ensure that their spreadsheets are compliant with FDA regulations for electronic records and signatures. ExcelSafe allows these companies to use the flexibility and economy of spreadsheets to perform FDA regulated activities. ExcelSafe provides users of Microsoft Excel with:

    • User Security – Entry into spreadsheets requires a user name and password. ExcelSafe 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 – ExcelSafe comes with tools to track all changes to spreadsheets. Users can query results from any spreadsheet.
    • Simplicity – ExcelSafe works automatically with existing spreadsheets and templates. Once a spreadsheet is opened in ExcelSafe, all compliance tools work automatically. Users operate Excel normally; there is no complicated interface to learn. ExcelSafe supports any number of users and any number of spreadsheets.

    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.


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  7. Implications & Practical Advice from the Blood Establishment Computer Validation Guidance

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    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 Services and Ofni Systems for a 90-minute teleconference to 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.


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  8. Excel Spreadsheet Validation 101 — Proven Techniques for FDA Compliant Spreadsheets

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    This page discusses a past conference.


    Click here to learn more about spreadsheet validation.


    Tyson Mew, president of Ofni Systems, will speak at IVT’s 14th Annual Computer and Software Validation conference in Philadelphia, PA, from April 17 through April 19. On Thursday April 18, 2013, Ty Mew will be a featured speaker, giving the presentation:  Excel Spreadsheet Validation 101 — Proven Techniques for FDA Compliant Spreadsheets.

    Learn how to Create and Validate Spreadsheets in FDA Regulated Environments

    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.

    Institute for Validation Technology

    IVT’s 14th Annual Computer and Software Validation conference is a three-day conference to discuss evolving computer and software validation practices. From the emergence of virtual networks, cloud computing and social media, the urgency of securing data integrity and complying with global regulations has never been greater. This conference aligns global regulations, best practices and case studies featuring the best CSV speakers to discuss developing, implementing and maintaining best validation practices in regulated environments.

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

    Registration information for the 14th Annual Computer and Software Validation conference is available.


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  9. 20th Annual ISPE CASA Life Sciences Technology Show

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    Tyson Mew, president of Ofni Systems will be at the 20th Annual ISPE CASA Life Sciences Technology show at the Raleigh Convention Center in Raleigh, NC on Tuesday, March 26, 2013. Ty will be demonstrating how FastVal can reduce the time your organization requires to do validation projects by up to 70%.

    ISPE Carolina-South Atlantic Chapter is a not-for-profit volunteer society of technical professionals who apply their practical knowledge in the regulated pharmaceutical and medical device manufacturing industries. ISPE is committed to the advancement of the educational and technical efficiency of its nearly 1300 members through forums for the exchange of ideas and practical experience.

    Ty Mew and Ofni Systems will be available throughout the conference to discuss validation, demonstrate their validation automation tools and accept resumes from validation professionals.

    Registration information for the 20th Annual ISPE CASA Life Sciences Technology show is available.


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  10. Getting Started with Validation –
    What To Validate, When to Validate, How to Prove You Validated It – 11/15/2012

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    Getting started with computer validation can seem like an expensive and impossible task. Too often, organizations only perform validations as a reaction to observations, validating systems one by one. Even if this addresses the immediate observation, the next audit reveals yet another system that is out of compliance creating a history of non-compliance. One of the secrets of computer system compliance is that a well-controlled compliance program adds value to your organization. While validation may seem like a cost, an efficient validation program enhances the value your organization by improving quality to your suppliers, reducing business and regulatory risks, and supporting the training and administration required to allow your organization to grow and thrive.

    Attendees will learn the following:

    • Which out your computer systems need to be validated… and which do not.
    • The documentation FDA auditors expect to demonstrate 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.
    • The regulations that your computer systems must comply with, and the procedures that document that compliance.
    • The procedures required to ensure compliance with 21 CFR 11 and Annex 11.
    • What to ask for when purchasing computer systems that will be used in GxP environments.
    • Industry best practices to maximize your validation resources.
    • How to bring System Owners, Users, and Quality together to improve your business..

    On Thursday, November 15, 2012 at 1:00 EDT, join FOI Services and Ofni Systems for a 90-minute teleconference to gain practical knowledge about desktop database compliance and validation, including specific, practical advice on creating compliant desktop databases, validation methodology, and maintaining desktop databases in GxP environments.

    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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