Bio-Rad will launch two regulatory tools for the ProteOn XPR36: the ProteOn Manager 2.1 security edition software and the ProteOn XPR36 installation qualification and operation qualification kit
These regulatory tools will be key to pre-clinical and clinical development of therapeutics as well as manufacturing and quality control.
The ProteOn Manager 2.1 security edition software is designed to assist customers in pharmaceutical drug development meet the requirements for 21 CFR part 11 by providing functionality for maintaining data security, data integrity, auditing, and the traceability of electronic records.
Electronic signatures - reviewers and approvers will be able to digitally sign records.
The name, date, time, reviewer/approver status, and reason will be associated with each signature and tracked by the software.
All electronic signatures will require a username and password.
Audit trail - all auditable changes will be recorded, including the date and time, originator of the record, and other related information.
The audit trail cannot be changed or deleted by the user.
Data validation - accuracy of electronic copies will be confirmed using a secure checksum to detect invalid or altered records.
Identification codes and passwords - the system administrator will be able to set up a unique user identification code for each individual user.
User identification codes cannot be reused or reassigned to others.
The Windows operating system ensures that all active user identification codes are unique and that all identification code and password combinations are unique.
Device check - the software will record the identity, such as the serial number of the ProteOn instrument that it is controlling.
System permissions and authority - access rights will be based on those assigned within the Windows domain/ workstation user database.
ProteOn Manager Security Edition software uses the Windows operating system security feature to authenticate users and retrieve access levels via group membership.
User permissions will determine access to the software functions.
Generation of copies - accurate and complete copies of the data will be generated within ProteOn Manager software, for example, using the "Save As" feature so it may be accessed later for inspection and review.
The application also enables export of electronic records to ASCII, XML, or Excel file formats.
The ProteOn XPR36 installation qualification and operation qualification (IQ/OQ) kit will enable drug discovery and development researchers to validate and record instrument performance.
The IQ/OQ kit has been designed to test critical system functions to ensure reliability and consistency of system performance.
The kit will include control reagents, fully automated software, and reporting functions.
Key benefits include wizard-driven software, printable electronic reports for document control, electronic log of IQ/OQ and test results, ready-to-use reagents and sensor chip for testing system performance, and unattended operation.
The new software and kit will be available this summer.
