During the equipment/instrument validation lifecycle, the industry faces the challenge of critical data being scattered as silos across different systems and paper-based records. The inability to integrate data promptly can reduce efficiency and hinder in obtaining key equipment lifecycle data to make objective decisions. In addition, there is a need to assess the impacts of changes to the validated state of equipment during its lifecycle. All data elements are managed and tracked in disparate systems, documents, and spreadsheets. With no clear validity of data elements, islands of data in different formats, and a lack of a definitive audit trail make it extremely difficult to correctly assess and determine the status of validation.
ValGenesis enables efficiency and provides superior data integrity with a paperless validation lifecycle process. Our VLMS eliminates the inefficiencies that plagued paper-based validation processes and allows users to fully automate the entire equipment lifecycle from validation planning to decommissioning/retirement. As a result of our 100% electronic platform, nearly all time-consuming manual activities (printing, scanning, routing documents, etc.) are eliminated. With our VLMS, any enterprise can fully automate the entire equipment lifecycle, enable paperless operation of the equipment/instrument validation lifecycle.
ValGenesis clients can design workflows and decision trees that will fully automate protocol generation and are empowered by a risk-based approach to equipment/instrument validation. Our VLMS’s electronic protocol execution functionality allows users to execute protocols from authorized laptops or tablets with or without the network/internet connections. The system automatically identifies the engineer performing execution of each test step with an electronic signature and date/time stamp. If an added level of security is desired, it can also enforce a verification signature. Users also can link or associate executed test steps with evidence such as screenshots, file attachments, and video/audio files. Execution failures can be easily managed with deviations workflows within the system.
In addition to digital validation, ValGenesis VLMS accesses parsed data and any associated raw data files directly from your instruments and dynamically collects process parameters from that equipment based on the defined schedules. These innovative functions help to reduce the time required to collect data with a high level of integrity. Our eLog module helps to collect log data during the lifecycle of the equipment/instruments, including calibration logs, periodic reviews, cleaning/usage logs, etc. Overall, ValGenesis provides a complete solution to manage the equipment/instrument lifecycle in a 100% paperless environment.