ERP System Validation for Cold Chain & Pharma Compliance Process

In cold chain industry, it is essential to validate various assets and processes. This is especially important in the pharma industry. This is required to ensure that the quality of medicines is not compromised throughout various stages from manufacture until final distribution. As part of this, we are offering software validation for pharmaceutical manufacturers and distributors.

Software validation of monitoring systems

The real-time monitoring systems consist of hardware and software. The hardware consists of various sensors, display, transmitters, receivers etc. The software consists of the user interface, cloud storage, report generation etc. In a real-time monitoring system, the data passes through various hardware and software paths before it generates a report. Most often, the user is using mainly the reports. The validation process is to ensure that the entire system maintains accuracy throughout the process from the sensor to the report generation. It is possible that the data loses some accuracy as it passes from a sensor to the receiver, to the transmitter, to the cloud platform, back to a computer, generating a report etc. A validation process is an end to end verification process to check that the data is not lost throughout this entire process. We will be testing the hardware and the software for this process. We will monitor the data and collect the data at the intermediate points to generate analysis.

Software validation of ERP software

ERP software also is crucial in the cold chain process. An ERP software transacts and stores various data in the process. Few of them are very critical such as expiry date, stock position, quality inspection, daily transaction details etc. In order to ensure that the ERP software carries out all these transactions accurately, it is necessary to validate the ERP software. The validation involves testing of data related to various processes in the system.

We segregate the processes in the ERP into separate streams to analyze each stream. The accuracy of data transmission is also important for ERP software operated over a cloud-based storage system. In an ERP system, access to a database is difficult. However, the input and output data streams can be tested. The report typically includes the verification of all such data streams across a period of time. The accuracy of data over a period of time is tested.

VackerGlobal‘s software validation services complement our other validation services for cold chain and pharma industry:

1. Validation of Shipping processes.
2. Validation of Cold Chain packaging process.
3. Validation of Cold rooms for medicine and vaccine storage.
4. Validation of warehouse for medicine storage.
5. Validation of reefer trucks and vans for medicines and vaccine distribution.
6. Validation of active and passive cool boxes.

A sample protocol for validation of software