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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.
Ofni Systems, Inc.
Phone: (919) 844 – 2494