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The Division of Nuclear Medicine at Dana-Farber Cancer Institute had two validation needs:
Dana-Farber Cancer Institute (DFCI) wanted to be certain they were in compliance with FDA rules for clinical trials and contacted Ofni Systems Inc. for assistance. Ofni Systems donated the use of three of their software packages, the FastVal Document Generator, Part 11 Toolkit, and ExcelSafe.
Ofni Systems applied the Part 11 Toolkit to Dana-Farber’s PET/CT Database. The Toolkit provides programs with technological tools to become compliant with 21 CFR 11. These tools include user-level security and password protection, which controls access to the database, an audit trail, which records all changes to system data, and electronic signatures, which prevent changes to data in the database.
Technological tools are only one aspect of compliance; software also requires validation. Using FastVal, validation professionals gathered software requirements for each screen, data workflow, and security requirement. FastVal generated a Functional Requirements Specification based on these requirements. Each requirement was linked to the appropriate requirement in the Software Design Specification. Using the Protocol builder function in FastVal, validation professionals were able to develop appropriate testing protocols. All documents were reviewed and approved before protocol execution.
Requirements were tested through protocol execution. FastVal allowed DFCI to execute protocols electronically. Each test step was executed, with results recorded through text and screen capture.
In addition, Ofni Systems helped ensure DFCI Excel spreadsheet compliance with 21 CFR 11. MS Excel is a flexible tool for data storage, but it does not have the technological controls to be compliant with 21 CFR 11 or HIPAA regulations. ExcelSafe provides Excel spreadsheets with user-level security to control access to spreadsheets and audit trails and electronic signatures to control spreadsheet data. One of the advantages to using ExcelSafe over other traditional methods of spreadsheet validation is that the original data file, not just the paper output of the spreadsheet, is validated. This means the spreadsheet data can continue to be used for GxP reporting purposes.
Once the technological controls had been added to the spreadsheets, DFCI used FastVal to validate their spreadsheets. FastVal facilitated the validation process. Validation professionals entered requirements for the spreadsheets. They generated Functional and Design Specifications for each spreadsheet. They produced Operational Qualifications for each spreadsheet, and executed the protocols electronically. By using FastVal, DFCI was able to quickly and efficiently validate their entire spreadsheet library and become compliant with 21 CFR 11 and HIPAA.
FastVal, Part 11 Toolkit, and ExcelSafe allowed the DFCI Division of Nuclear Medicine to quickly and efficiently become compliant with 21 CFR 11 and HIPAA.
Dana-Farber Cancer Institute documented their compliant database in the medical paper “Development of a PET/CT database of patient information and scanning parameters” (Syrkin, deVries, Lefever, Locascio, Kuzuhara, Van den Abbeele, and Yap). This paper includes screen shots of a database using the Part 11 Toolkit and acknowledges the Ofni Systems role in establishing regulatory compliance.
The mission of Dana-Farber Cancer Institute is to provide expert, compassionate care to children and adults with cancer while advancing the understanding, diagnosis, treatment, cure, and prevention of cancer and related diseases. As an affiliate of Harvard Medical School and a Comprehensive Cancer Center designated by the National Cancer Institute, the Institute also provides training for new generations of physicians and scientists, designs programs that promote public health particularly among high-risk and underserved populations, and disseminates innovative patient therapies and scientific discoveries to our target community across the United States and throughout the world.
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 their 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.