VConnect is an automated data collection software module that enhances ValGenesis’s VLMS ability to automatically capture test results and process parameters from analytical instruments and manufacturing equipment. This solution plugs data directly into validation protocols, electronic batch records, and equipment usage logs.
Currently, many validation activities are performed by the traditional, time-consuming, paper-based or hybrid systems wherein data is manually entered, and process parameters collected from instruments/equipment. Recognizing that this process is highly susceptible to data integrity issues, human errors, and inconsistencies, organizations using ValGenesis VLMS with VConnect replace manual data entry with automatic capture of these values, enabling a higher level of data integrity. VLMS allows life science companies to reduce validation cycle time while improving data integrity and regulatory compliance.
Role of VConnect for Data Integrity:
FDA and other global regulatory agencies have adopted ALCOA attributes to verify data integrity
- Attributable – Defining source data and identifying who performed an action on it
- Legible – Permanent recording of information and access to easy reading any time
- Contemporaneous – Recording date/time when work is performed
- Original – Justifying information/data is an exact copy
- Accurate – Ensuring data accuracy, with no errors or unauthorized alteration
ATTRIBUTABLE: DEFINING SOURCE DATA & WHO PERFORMED AN ACTION ON IT
Systems are instrument and user-centric, and hence will help users quickly identify a data source (i.e. which device generated the data).
LEGIBLE: PERMANENT RECORD OF INFORMATION & EASY ACCESS TO READING
Our systems maintain a permanent record in a central database, which resides in a controlled server environment. Data is available to authorized personnel for use/viewing. Archived data can be restored and read seamlessly. Data is captured and stored in a readable format (pdf).
CONTEMPORANEOUS: RECORDING DATE & TIME WHEN WORK IS PERFORMED
ValGenesis VLMS and VConnect allow usage or recording of data in a contemporaneous manner. They simultaneously record the date/time at which data is captured for simple instruments.
ORIGINAL: JUSTIFYING DATA IS A TRUE COPY
Data captured is always accurate and directly from an instrument (via RS232 or TCP/IP). Also, for complex devices, the original file generated by the instrument software is captured. After a file is generated and if it is modified (mostly through the instrument software) these software systems will capture the new modified file and version it automatically.
Features and Benefits of VConnect
Manual data capture and entry during validation activities are ineffective, inefficient, prone to human error and time-consuming. With VConnect, however, your organization can experience the benefits of implementing a fully automated data capture process to automate the Validation lifecycle processes.
- Automated capture of raw data and metadata generated by analytical instrument(s)
- Supports RS232, TCP/IP, and PC-based instruments/equipment
- Increased levels of compliance with data integrity
- 100% electronic approach to the instrument data capture in Validation Lifecycle
- Automates instrument data capture in validation lifecycle, capturing data and results directly into the validation protocols to eliminate manual data entry
- Archive primary raw data files from lab instruments as part of the Scientific Data Management system
- Improved sample turn-around time
- Compliance to 21 CFR Part 11 & Annexure 11