Developments

We are continually developing new functionality and improving existing features.

As part of this ongoing process we are developing a highly configurable and fully validated software solution that will electronically manage all areas of the pharmaceutical manufacturing process.

This will include the definition of electronic work instructions (EWI), the weighing and dispensing of raw materials (DMS), the electronic data collection (EDC) of batch manufacturing information and the production of the electronic batch record (EBR).

It will be a modular system which can easily be implemented in manageable stages to improve one, some, or all of your manufacturing processes.

Electronic Work Instructions (EWI).

These include all aspects of the batch recipe including formulae, manufacturing stages and work instructions. This will help to maintain uniformity over the manufacturing process for all of your products.

The system will provide the ability to define batch formulae enables parameters such as yield quantities, weighing tolerances and machine settings to be calculated based on actual batch information. All EWIs will be maintained under version control with a version number, status and multiple approval roles.

Electronic Data Collection (EDC).

Typical actions at the start of a manufacturing stage would be to ensure that:

• The equipment is clean and has been validated for use
• The correct protective equipment is worn
• Other health and safety checks have been adhered to

The operator is then led through the manufacturing process for the selected stage. For example, for the weighing and dispensing of pharmaceutical raw materials the system will ensure that:

• The correct material with valid QC status is identified
• The correct amount of material is weighed
• A standard operating procedure is followed

Performance Analysis and Reporting.

The system will be supplied with a comprehensive set of Performance Analysis and Reporting functions. The principal GMP report is the Electronic Batch Record (EBR) however all captured information will be available for analysis. For example, you will be able to analyse the current manufacturing status across all work areas and perform comparison analysis across multiple batches of a product.

If you would like to find out more please contact us.