Worxsimple can help validate your processes and equipment. We analyze your application for gaps in documentation, potent sources of error, missing components and inadequate specification. We can generate system reports, missing documentation, and procedural changes for complete validation.
Equipment Specification Drafts
We analyze your production to develop your Equipment Specifications by clarifying your needs.
Process Specification Drafts
We can develop and clarify your process settings for documentation purposes. If necessary, we can fully define your process parameters and install additional controls to eliminate process variation.
Protocols and Qualification Development and Execution
We travel to your vendor locations or your manufacturing site and act as your representative for equipment runoff and acceptance for the following activities. You, as the customer, always have the final say and authorization of the protocols.
- Factory Acceptance Testing (FAT) – Procedures Execution and Final Reports
- Site Acceptance Testing (SAT) – Procedures, Exectution and Final Reports
- Installational Qualification (IQ) – Procedures, Execution and Final Report
- Operational Qualification (OQ) – Procedures, Execution and Final Report
- Process Qualification or Verification (PQ) -Procedures, Execution Assistance and Final Report. For PQ activities, you as a manufacturer already have established systems. We can help you develop your protocol and assist in the execution, but your process and management must conduct the PQ