ValGenesis, Inc., a market leader in Enterprise Validation Lifecycle Management Solutions (VLMS), announced its release of VConnect, an automated data collection software module that enhances ValGenesis’ VLMS ability to automatically capture test results and process parameters from analytical instruments and manufacturing equipment, and directly plugs data into validation protocols, electronic batch records and equipment logs.
Currently, validation activities have been performed utilizing time-consuming, paper-based or hybrid systems with manually entered QC test results and process parameters collected from instruments and equipment. Recognizing that this process is highly susceptible to data integrity issues, human errors and inconsistencies, organizations using ValGenesis VLMS with VConnect replace manual entry of test results and process parameters in their validation documents/protocols, batch records and log books with automatic capture of these values, enabling a higher level of data integrity and automation. This will allow life science companies to reduce validation cycle time while improving data integrity and regulatory compliance.
Benefits of ValGenesis VConnect
- Automatic parsing of raw data ﬁles and extraction of meaningful data
- Automated capture of raw data and metadata generated by analytical instrument(s)
- Supports RS232, TCP/IP and PC-based instruments and equipment
- User-conﬁgurable schedule manager for data capture and secure archival with version control
- Integrated with ValGenesis VLMS to eliminate manual data entry into validation protocols
- Audit trail and electronic signature support for 21 CFR Part 11 and Annex 11 compliance
Since C&Q, analytical method, process and cleaning validations are instrument-, equipment- and user-centric, VConnect’s dynamic data collections are attributable to the instrument that generated the data along with the time of generation. VConnect also addresses manual data entry issues that contribute to data integrity concerns by seamlessly supporting RS232 or TCP/IP interface protocols. For complex instruments, VConnect automatically captures original files generated by the instrument software and, if modified (via instrument software), VConnect captures and versions these file(s).
Manual data capture/entry during validation activities is inefficient, prone to human error and time consuming. With VConnect, life science organizations can now experience the benefits of implementing a fully automated data capture, compliant with 21 CFR Part 11 & Annex 11 requirements. In addition, both PC- and non-PC-based lab instruments can be integrated to VLMS via VConnect and primary data from lab instruments can be archived as per the corporate data retention policy.
“ValGenesis VLMS has been trusted by a number of global life science companies for paperless validation and is committed to continual improvement. As part of this commitment, we continue to evolve our offerings, in line with the evolving needs of our customers and the ever changing regulatory requirements they must meet, as well as their respective technology landscapes and business environments. We seek to enhance quality assurance, data integrity, and regulatory compliance while improving the overall efficiency of corporate validation programs. VConnect will enhance data integrity in the validation process while setting a new standard in paperless validation,” said Dr. Siva Samy, CEO & Chief Product Strategist of ValGenesis, Inc.