Automating the Phase 1 and Phase 2 investigations can improve the efficiency of the test results. It can help ensure the correct procedures are followed to meet regulatory requirements. Further, it also helps with collaboration between different teams, especially in Phase 2, when the QCU works with all relevant stakeholders, even in offsite locations.
Documentation is another regulatory requirement that can be easily handled with an automation solution such as ComplianceQuest’s cloud-based Laboratory Investigation Software.
The LIS is integrated with the CQ enterprise-wide quality management system. As a result, pharma companies can also leverage the CAPA solution that can be triggered when the cause is identified. This can help correct the issue and prevent its future recurrence.
Not only the affected batch, but tests may have to be conducted on other batches of the same product or other batches. The CQ solution helps to have greater visibility and access to data at every step to speed up OOS investigation for accurate results.