Pre-manufacturing steps for Life Sciences organizations are quite elaborate and often subject to review during audits. Manufacturers continuously look to eliminate potential bottlenecks that can threaten their efficiency and traceability.
Why traceREADY Pre-Manufacturing?
Typically, most of the pre-manufacturing processes are maintained in paper records with limited in-process automated checks.
The receiving processes covering multiple ASNs, vendor batches, POs, etc., which makes warehouse management complex which can lead to additional time and errors in initial material process. Labelling each container appropriately is essential. The complexity multi-folds when multiple labels are affixed in each container at each stage.
Information maintained in ERP is normally at an aggregate level without any data related to individual containers. The status of individual containers can be only verified based on the labels attached to the container. This leads to difficulties in handle picking and dispensing. There are some instances where mix up of material goes undetected while dispensing material to a process order.
Batch record maintenance along with dispensing details are quite time consuming and manual. This can be significantly reduced with device integration and automated data capture. It is also paramount importance to maintain all records for device calibration and verification while use of these devices.
How can Navitas Life Sciences help?
traceREADY Pre-Manufacturing starts the process, streamlining from the receiving of raw and packing materials until the dispensing of the material to the manufacturing floor. The solution addresses the in-process controls required to meet the regulatory compliance. 21 CFR Part 11 requirements are well designed in the solution for fitting into a regulated environment.
With traceREADY Pre-Manufacturing, the processes are switched with in-process controls. This makes use of the application comply with the regulatory needs while recording the entries in the Point-of Action and reducing the errors during data capture. The time taken from receipt of material to dispensing is considerably reduced by this application.
This solution designed by Navitas Life Sciences seamlessly integrates with multiple ERPs, enterprise applications, interfaces with industrial devices, and mobile devices to drive business processes.