Compliance Requires a Solid ERP Foundation

Compliance Requires a Solid ERP Foundation

​​​​​​​Companies in pharmaceutical and life sciences manufacturing share a technology requirement for a strong enterprise resource planning (ERP) system to enforce the common principles of validation projects. The goal of these validation projects is to demonstrate consistent, secure and traceable transactions for any product throughout all stages of its lifecycle. By examining three key pillars of applications validation, the importance of the underlying ERP system becomes evident.

Consistent Processes: Life sciences and pharmaceutical companies depend on ERP systems to help maintain consistent and repeatable quality. First and foremost, the recipes (the formula or bill or material [BOMs] and the routings) must be approved and locked into place so that when production is launched, only the authorized recipe is issued. These recipes are tied to specific documents called “operations procedures” which outline the specific materials, quantities and processes necessary to make a consistent quality product. The recipes require valid quality control testing with operational tie-ins to ensure an intermediate meets the specifications before it moves to the next operation. Any raw material, intermediate or finished product that is tested and falls outside of the pre-defined specification must immediately generate a non-conformance alert that is sent to internal stakeholders. An authorized formula, tied to its approved operations document, tied to an internal quality management application, is the first step to maintaining consistent processes.

Secure Processes: The CFR Part 11 compliance code addresses security.  ERP applications help support security requirements by applying electronic signatures to insure authorization for certain business process steps. For example, many life sciences companies lock down their formulas or BOMs in order to comply; and in most cases, authorized individuals can look and review formulas, but not change them. Electronic signatures can add another level of password requirement, so if someone tries to change or update a formula, a pop-up window requests an additional password. Electronic signatures frequently are used with formulas, BOMs, routings, quality specifications, and operations procedure documents.

Traceability:  The final pillar of control is the ability to track all components of the product from its raw material purchase through work in process to the final customer ship-to location. Many pharmaceutical manufacturers have co- and by-product issues, and some split and merge lots during the production process. It is essential for an ERP application in companies with highly regulated environments to manage both discrete (medical device manufacturing), as well as process (pharmaceutical and life sciences manufacturing) production requirements.


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