Regulated BlueNotes 420 Software is designed to provide features that enable users to operate their 420 Series (420/425/420Cs) Flame Photometer in a manner compliant with data handling standards such as 21 CFR Part 11.
(To fully comply with 21 CFR Part 11, it is important for an organisation that uses electronic records and electronic signatures to have SOPs (Standard Operating Procedures) that support and complement the functionality within the analytical system being used. In addition, it is also the responsibility of the organisation to ensure all personnel involved have an adequate level of education, are aware of, and are trained on 21 CFR Part 11 related issues.
Companies that need to comply with this regulation must define their own realistic requirements.
Compliance is not the responsibility of the equipment or system supplier; who can only provide systems that support and enable an organisation and their operatives to work in compliance).
In addition to 21CFR Part 11, the software also expands functionality of the 420 Series of Flame Photometers; allowing data collection from all three (or four – M425 only) element detector channels simultaneously in one sample sequence and to operate the instrument with multi-point calibrations, which allows analyses to be performed beyond the limits of the instrument’s linear response range and therefore analysis of samples over a greater concentration range.
Regulated Bluenote’s 420 Software Features
- 3 tier login system with different levels of access (Operator, Supervisor and Administrator)
- Unique name and password for all
- Audit trail records all operations with detailed information concerning the user and the software version; Windows version and PC name to ensure traceability and accountability
- Robust tamper evident data file system which is inaccessible to users without elevated Windows privileges
- Tamper evident data format used for analysis result, system configuration and method files to ensure data integrity
- Auto generated PDF analysis reports provide a comprehensive summary of all information relevant to an analysis run in one clear and concise document
WHAT IS 21 CFR PART 11?
21 CFR part 11 is a regulation issued by the American FDA (Food and Drug Administration) to define the requirements for submitting documentation in electronic form and the criteria for the use of legally binding electronic signatures.
CFR relates to the “Code of Federal Regulations”.
Chapter 21 covers all regulations pertaining to GCP (Good Clinical Practice), GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice): collectively designated GxP, relating to the Pharmaceutical and Healthcare Industries.
Part 11 covers all FDA regulated issues pertaining to electronic records and electronic signatures.
The regulation is of importance to all U.S. Pharmaceutical and Healthcare companies, together with all International Pharmaceutical or Healthcare companies wishing to or currently exporting to the USA. In addition to the above, many countries or companies use the regulation as a guideline for development and implementation of their own guidelines or regulations; to,
- allow the use and submission of electronic records instead of having to store and submit a mass of paper documentation.
- prevent or at least reduce the risk of records being deliberately manipulated to falsify results.
- To prevent unauthorised access to data.
- Ensure traceability of records to their originator or owner.