This software is said to be the first gel and blot imaging software to be compatible with US FDA 21 CFR Part 11 regulations
2003 Bio-Rad Laboratories says that it has added regulatory functionality to the Discovery series software used for imaging and analysing gels and blots.
This software is said to be the first gel and blot imaging software to be compatible with US FDA 21 CFR Part 11 regulations (electronic records; electronic signatures).
Bio-Rad's Quantity One 1-D analysis software and PDQuest 2-D analysis software programs are used in thousands of laboratories worldwide for basic research, drug discovery and quality control of DNA and protein samples.
Now, with the new Quantity One 4.5 and PDQuest 7.2 software, users can satisfyUS Federal Food and Drug Administration control requirements for electronics record systems and electronic signatures under FDA 21 CFR Part 11 regulations relating to gel electrophoresis imaging and analysis.
Companies developing and manufacturing drugs and cosmetics are required to meet these regulations.
Easy-to-use Quantity One software provides image analysis tools, enabling researchers to clearly visualise their first dimension electrophoresis data.
PDQuest is designed for laboratories running large numbers of 2-D gels simultaneously, offering the most powerful 2-D analysis tools on the market. "Researchers' needs are constantly changing, and we are committed to delivering innovative solutions to meet those needs," said Martina Palm, Bio-Rad software and bioinformatics product manager.
"Since our software is used by both academic and commercial researchers who require differing 21 CFR Part 11 compliance functionality, we offer this as an optional module".
The Discovery series new security model operates in tandem with Windows security functions.
The CFR modules require Windows 2000 or Windows XP Professional to comply with the FDA regulation (imaging analysis applications also run on Mac OS 9 and Mac OS X operating systems).
This security function provides access controls and authority checks via user identification codes and passwords, enabling varying levels of authority to be assigned to system administrators, users, technicians and guests.
Original raw data is saved in a backup file that cannot be modified or accessed by unauthorised users. Additionally, records created on 21 CFR Part 11 systems cannot be opened on non-compliant systems, and records created on non-compliant systems cannot be opened on 21 CFR Part 11 systems. Secure, time-stamped audit trails are implemented within Quantity One and PDQuest to independently record date and time of operator entries and actions that create, modify, or delete electronic records.
The name, date, time, and reason for each signature is stored as part of each electronic record.
When a signature is performed, the associated data is automatically saved and locked.
