The TrackWise by Sparta Systems Sample Tracking solution ensures securely documented chain of custody information, by tracking samples from initial check-in through disposal or long term storage.
TrackWise Batch Record delivers the flexibility to support batch record review and release functionality in a number of different business models.
TrackWise by Sparta Systems solution for Out of Spec/Out of Trend (OOS/OOT) ensures potential product non-conformances are properly and efficiently investigated and handled through the tracking and managing of the initial report, phased investigation, root cause analysis and any resulting Corrective Action and Preventative Actions (CAPAs) and change controls.
The TrackWise by Sparta Systems Deviations Management solution allows a broad range of deviations to be tracked and managed from initial inception, through investigation, root cause analysis through to the execution of corrective and preventative actions (CAPAs) and subsequent change controls.
The TrackWise Product Recall/Product Withdraw solution improves response time to potential recalls by automatically tracking and managing the decision process to recall products from the initial recall request submission through the evaluation and resulting recall decision.
Monitoring and tracking the efficiency and accuracy of organizations' drug safety reporting process can help to ensure issues are logged and investigated when they arise, avoiding delays and/or inaccurate reporting which can result in lack of regulatory compliance, monetary fines, and unwanted scrutiny.
The TrackWise Change Management solution ensures all documented changes are properly coordinated while increasing transparency by managing the change control process across all relevant departments from initial request, through pre- approvals, change execution, follow up approvals and implementation.
TrackWise by Sparta Systems' Adverse Event Reporting solution tracks reported adverse events and manages the processing of all cases from initial triage through reporting and case closure.
TrackWise by Sparta Systems' drug safety solution enables pharmaceutical / biopharmacutical companies of all sizes to reduce product safety risk, achieve compliance, and improve efficiency of pharmacovigilance processes.
The TrackWise nonconformance solution ensures product non-conformances are properly and efficiently handled through an integrated process that tracks and manages the complete process from the initial report, to the investigation process and root cause analysis to any resulting actions and follow up verification of effectiveness.
Without a means to track and schedule, drug safety audits tend to be performed on an irregular basis, typically resulting in disconnected audits with recommendations that not followed up on.
The TrackWise by Sparta Systems IT Process Management Software assists companies foster quality and increase return on investment of IT operations by improving IT processes.
As authorities strengthen their oversight of regulated industries and increase the frequency of inspections, companies must be prepared to not only meet strict internal operational compliance requirements but also ensure the quality of goods and services provided by an increasingly global network of suppliers.
Standard system measures 37.5"W x 29"D (24"D at top) x 39"H and includes an externally mounted fluorescent illuminator and dual 8" flanges for gloves (order gloves separately).
Terra's Softwall Modular Cleanrooms provide an economical, versatile solution to clean manufacturing requirements in semiconductor, medical device, and many other industries.