The system operates in an access controlled environment. Hence the users would have a defined role in the system and can operate only as per the rights given to them.
The system stores all the GTIN number of the products of the company. Hence at the time of the production, only Production Date, Expiry Date, Batch number needs to enter into the system. Once the information is entered, it is automatically sent to the printer without any further action and prints on boxes with random serialization.
If an inspection camera is connected to the system, it reads the barcodes and aggregates to reconcile in the system automatically. Therefore, the good codes and bad codes are parked automatically.
The system should have an Audit Trail being maintained at all times. Which means, any and all actions taken on the system are being recorded in the database and can be reviewed by the Authorized personal only when needed.
Especial consideration need to be given on the Data Management of Serialization to ensure smooth operational experience is given to the client.
With the additional security and functional features of CFR 21 Part 11, the software needs to be robust and flexible to operate in various configuration and environment with impacting on performance.