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  1. 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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  2. 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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  3. 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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  4. 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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  5. FDA Releases Laboratory Investigation Bulletin Discussing their Use of ExcelSafe

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    excelsafeMS Excel is the FDA’s software of choice for processing results, analyzing and presenting scientific data in their chemical and microbiological laboratories. The FDA, like many organizations, uses Excel to record test results and other report data, and needs compliant, password protected spreadsheets. The San Juan District Laboratory wanted to retain the power and flexibility of Excel for their analysts, while transitioning to a paperless environment and remaining compliant with 21 CFR 11. In order to achieve these goals, the San Juan District Laboratory selected ExcelSafe by Ofni Systems.

    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 “Evaluation of ExcelSafe to Implement Part 11 Rules in FDA Analyst WorkBook Files” detailing their experiences with ExcelSafe.


    Click Here To Download
    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.
    Learn more about ExcelSafe

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

    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.


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  6. FastVal Press Release

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    Ofni Systems, a leader in providing regulatory compliance solutions for pharmaceutical, biotech and medical device companies announces the release of FastVal Validation Document Generator v3.0. FastVal allows users to complete validation projects in 70% less time than using traditional validation methods. FastVal is compliant with all FDA/EU rules for electronic records and signatures, including 21 CFR 11 and Annex 11 and implements industry recognized best practices for validation, including GAMP 5. This release enhances FastVal’s ability to help enable organizations execute all aspects of their validation projects with shorter timelines and increased quality.

    • Creates All Required Validation Documentation – FastVal can generate any document your validation process requires. Many validation deliverables, included Requirement Traceability MatricesDeviation ReportsSummary Reports and Change Control Reports can be created automatically through internal wizards. FastVal includes templates provided by Ofni Systems, or can be modified to use your organizations existing templates. All documents can be generated as Microsoft Word or PDF files.Key Features of the FastVal Document Generator include:
    • Electronic Protocol Execution – FastVal allows users to execute test protocols electronically. Evidence of protocol execution is supported through text and screen capture. Electronic protocol execution uses electronic signatures to verify the identity of testers. Complete 21 CFR 11 audit trails document the protocol execution.
    • Automatic Deviation Tracking – Deviations are created automatically when actual testing results do no match expected results. Deviations and be resolved internally within FastVal, or exported to your deviation tracking tool for resolution.
    • Validation Project Management Tools – PStakeholders can see document and protocol status, follow deviations to resolution, and calculate validation metrics (including tracking requirement completion).
    • Updated Test Protocol Creation Tools – The Microtest Writer provides templates for commonly used functionality. This allows for quick creation of test cases by providing an interface to replace specific variables which are then automatically integrated and used to populate the test scripts. Highlights of this release include:
    • Updated Risk Assessment Tools – Responding to increased regulatory requirements in Annex 11 and FDA best practices, FastVal has an upgraded interface for documenting risk associated with validateable objects. Users document the risk associated with requirements and export the risk to either a Risk Assessment document or report.
    • Requirements Burn-Down List – InteIntegrates the test writing function with the functional requirements and the Traceability Matrix providing visibility into which requirements have not been covered by corresponding test cases. Automatically links test cases to the functional requirements and system design specification to automatically create the customized trace matrix.
    • Updated Metrics Reporting – The system provides complete transparency into the status of your project. The review status of all documentation can be viewed including the status of test case execution. The system contains integrated deviation reports and provides estimates of expected test execution completion based on current progress.
    • Enhanced User Interface – The FastVal user interface has been harmonized and improved to facilitate new user training and program ease of use.

    These enhancements increase FastVal’s ease of use and allow users to shorten the validation cycle while increasing the quality of the finished validation project. Managers have greater visibility into the status of validation projects and can have confidence that their validated system will withstand regulatory scrutiny. “Validation should add value to a computer system,” said Ofni Systems Validation Manager Ofni Systems. “FastVal produces higher quality documentation, in far less time, which in turn allows us to spend our time testing software, rather than generating documentation. FastVal can be customized to any customer validation requirements, which allows us to meet and exceed all of our customer’s standards.”

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

    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.


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  7. Ofni Systems to Exhibit at PDA FDA 2012 Conference: Redefining the C in CGMP Press Release

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    Tyson Mew, president of Ofni Systems will be at the 2012 PDA FDA Joint Regulatory Conference in Baltimore, MD on September 10-12. The PDA FDA conference has the title “Compliance through Quality Systems: Implementing & Advancing a Sustainable Global Quality Culture”. In joint collaboration with the FDA, PDA has designed the conference to reflect how a robust quality system can enhance business goals and objectives. The conference will feature a series of regulatory and industry leaders in quality and compliance.

    Registration information for PDA FDA Joint Regulatory conference is available.Ty Mew and Ofni Systems will be available throughout the conference to discuss software compliance, 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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  8. CDR Increasing Emphasizing on 21 CFR 11

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    The FDA Center for Drug Evaluation and Research (CDER) is 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. This effort is part of CDER’s effort to evaluate industry compliance with 21 CFR 11. If inspections include observations that computer systems are not in compliance with 21 CFR 11, CDER intends on taking appropriate action to enforce Part 11 requirements. The timeframe for this CDER initiative has not yet been determined, but CDER wants the inspections implemented and completed soon.When 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.”

    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.At this point, other FDA centers are not involved, but they have been informed of the CDER initiative and will be monitoring CDER findings.


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  9. Designing & Evaluating 21 CFR 11 Compliant Access Databases

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    Ofni Systems will address validation and 21 CFR 11 with regard to usage of desktop databases, such as MS Access. Many drug and device firms find that Microsoft Access is a perfect software package for database management with familiar, easy-to-use features, good functionality and smooth integration with other common software. But what should you do to be sure your Access databases are Part 11 compliant? FDA requires evidence of your validation efforts, and regulated industry routinely sees the consequences of non-compliance-–every year, hundreds of 483s and warning letters are issued to companies who did not design or validate their databases to meet these requirements. If you’re using Microsoft Access for your databases, you have very specific Part 11 concerns, and you need to take special care to ensure you have the appropriate audit trails, security, and electronic signature requirements in place.

    The following topics will be covered in detail:

    • Learn what the FDA will look for during audits
    • How to define requirements quickly.
    • How to document inputs, code and security settings.
    • Details on when and where to use electronic signatures.
    • Inactivity timeouts, and controls for users and passwords.
    • Managing change control and common change control mistakes to avoid.

    On Tuesday, January 10, 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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  10. Get Started on your 2012 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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