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  1. 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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  2. 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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  3. 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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  4. Excel Spreadsheet Validation 101 — Proven Techniques for FDA Compliant Spreadsheets

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    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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  5. 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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  6. 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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  7. Increased Compliance Observations Related to Spreadsheets Press Release

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    Ofni Systems has recently become aware of several FDA warning letter observations relating to spreadsheets. In both cases, the observation related to spreadsheet formulas which were not properly secured. Ofni Systems wants to remind all people working in the FDA regulated industries that all computer systems, including spreadsheets, that are used to make Quality decisions or used to report information to regulatory bodies must be controlled. For spreadsheets, this includes having the ability to track if changes are made to a spreadsheet, who is accessing the spreadsheets and having appropriate spreadsheet validation package to ensure that spreadsheet formulas are appropriate to the task they perform.

    Earlier in 2010, the FDA Center for Drug Evaluation and Research (CDER) had been informing members of the pharmaceutical industry that its inspectors will increase enforcement of 21 CFR 11. Specifically, CDER will begin an inspection assignment of 21 CFR 11 requirements. When FDA representatives were distributing this information to members of the pharmaceutical industry, the key point was “Industry has had since August of 2003 to understand how we intend to enforce Part 11 as per the guidance and be in compliance. Therefore, the intention of CDER to take appropriate enforcement action should not be a surprise.”The full text of both warning letters is available on Ofni Systems’ web page Sample FDA 483 and Warning Letters.

    21 CFR Part 11 sets forth the criteria under which the FDA considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. This regulation, which applies to all FDA program areas, was intended to permit the widest possible use of electronic technology, compatible with FDA’s responsibility to protect the public health.

    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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  8. Ofni Systems to Exhibit at 2012 SCDM Annual Conference Press Release

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    Tyson Mew, president of Ofni Systems, and Russell Barbare, Clinical Operations Manager for Ofni Systems, attended the Society for Clinical Data Management (SCDM) Annual Conference in Los Angeles, CA on September 22-25. The SCDM (Society for Clinical Data Management) Annual Conference is the world’s largest education event for clinical data managers and related professionals, attracting over 600 attendees from across North America and around the world. Steven Wilson, the director at FDA/CDER/DBIII and at FDA/CDER/OB/DBIII, organized and led ten other speakers for the FDA’s presentation to the conference. The FDA representatives included five attending the meeting and six presenting by conference call, who between them represented the three largest FDA divisions dealing with clinical research: the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and Center for Drug Evaluation and Research (CDER). While the diverse presenters had many messages, the Prescription Drug User Fee Act, version Five (PDUFA V) and its ramifications were the primary focus of discussion.

    Director Wilson introduced the topic of PDUFA V and other presenters went into more detailed commentary. One FDA presenter talked about the increased communication allowed between the FDA and Sponsors in order to ensure timely drug development. A representative of CDRH noted that the law allowed for significant expansion of that branch of the FDA. Another presenter talked the initiative to interconnect federally administered databases with prescription drug information and allow the FDA access to them. Some of the databases mentioned were Medicare, Medicaid, and armed forces. Overall, it appeared that the FDA presenters were looking forward to working on the various measures prescribed in the new law.

    Director Wilson also introduced the theme that the FDA was further increasing the trend of expanding engagement with industry and other stakeholders. In addition to the expanded cooperation initiatives mentioned in the talks about PDUFA V sections, one of the major partnership goals is the development and implementation of clinical data interchange standards that are widely used and accepted. The primary discussion was the expansion of implementation of Clinical Data Interchange Standards Consortium (CDISC) standards. Related topics such as integration of clinical datasets based on CDISC standards and datasets based on Health Level Seven International (HL7) standards were also discussed.

    In summary, the FDA talk was an interesting sampling of thoughts and initiatives from multiple viewpoints that showed the agency is pursuing both many department-dependent initiatives and some strong agency-wide collaborative efforts with pharma and other stakeholders.

    Ofni Systems would like to thank all of our friends who came by to discuss clinical data mangement, Ofni Clinical and services provided by the Ofni Clinical Group.


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  9. Ofni Systems to Exhibit at IVT’s 18th Annual Validation Week

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    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


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  10. FDA Laboratory Information Bulletin 4524

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    FDA Laboratory Information Bulletin 4524

    The FDA publishes an internal Laboratory Investigation Bulletin (LIB) each month that is distributed to all FDA employees. It contains articles written by FDA employees that describe methods, procedures and products that a site has used that have demonstrated a high degree of success or an improvement over an existing method. The goal of these articles is to promote best practices to other sites within the agency. In the June 2012 issue, the San Juan District Laboratory released a Laboratory Information Bulletin 4524 detailing their experiences with ExcelSafe.

    The San Juan District Laboratory investigation showed that ExcelSafe improved the analytical spreadsheet’s application’s data integrity, security and template accountability by using electronic signatures, audit trails, and other compliance and tracking features. Using ExcelSafe improved laboratory efficiency by decreasing the time required for internal document review. They praised the ease of using ExcelSafe, noting that ExcelSafe had produced significant cost and time savings, and stated they would continue to use ExcelSafe.

    Download a copy of Laboratory Information Bulletin 4524 “Evaluation of ExcelSafe to Implement Part 11 Rules in FDA Analyst WorkBook Files”


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