Naica® System Pro Software (for 21 CFR Part 11 compliance)
An increasing number of laboratories are using electronic records and electronic signatures for exchanging and storing data. Electronic documentation offers many benefits, including increased efficiency and productivity when storing data and easier information sharing and data mining.
The Food and Drug Administration (FDA) of the United States (USA) regulates the food and drug industry of the USA with the Code of Federal Regulations (CFR). The FDA is within the Department of Health and Human Services and manages the Center for Devices and Radiological Health.
If a user’s organization or laboratory intends to use an electronic format instead of paper for records that are required under FDA regulations and requirements, the user´s organization or laboratory must comply with the regulations issued by the FDA: Final Rule 21 CFR Part 11 Electronic Records.
Title 21 of the CFR describes the requirements and regulations for the food and drug industries. For food and drugs to be used within the USA, they must comply with the requirements of this regulatory body. Manufacturers must register with the FDA and obtain approval for a license to distribute their product within the USA. Internationally, FDA regulatory compliance is recognized as a benchmark for the pharmaceutical industry with respect to research, drug development, drug manufacture and sales and marketing of pharmaceutical products.
Part 11 of Title 21 of the Code of Federal Regulations (referred to as 21 CFR Part 11) ‘Electronic Records; Electronic Signatures’ states the rules, definitions, and guidelines 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.” The rule defines a standard under which an organization must operate to comply with 21 CFR Part 11.
The naica® system Pro is a closed system, where access is controlled by users who are responsible for the content of the electronic records on that system.
The naica® system Pro software applications, described below, form parts of the ER system by which electronic records are created, modified, stored, and secured against further modification.
The naica® system Pro further provides electronic signature functionality.
Contents
- Naica® Data Service: naica® Data Service functions as the naica® system user account manager and controls the compliance of all naica® system operations with respect to 21 CFR Part 11 regulation.
- Naica® Reader Pro: naica® Reader Pro software application functions as the operating interface to define the experimental settings for the image acquisition on the scanner instrument (Prism3 / Prism6) for the Crystal Digital PCR™ workflow.
- Naica® Analysis Pro: naica® Analysis Pro software is the data analysis application of the naica® system. naica® Analysis Pro is used to analyze data from the images acquired using the naica® Reader Pro, and to calculate the absolute concentrations of targeted nucleic acids.
*For Research Use Only. Not for use in diagnostic procedures.
