When setting out to manufacture a batch of product a strict set of manufacturing instructions, described in the monograph, must be followed. These include quantities, instructions, testing instructions, packaging instructions, etc. The quantities and instructions are set up and implemented in ERP, while the testing instructions are set up and implemented in Process LIMS.

For each stage in the production model, a sample (or collection of samples) may be needed, it may even be necessary to complete the testing of a stage in Process LIMS before moving on to the next stage in ERP. Within Process LIMS a collection of samples for a stage is called a Control Point. These are equivalent to HACCP Control Points and using this structure helps enable compliance with the HACCP Guidelines.

These Process Specifications are version controlled and require second level approval before use.