Validation Services

Validation Services

Managing the Validation Life Cycle is key to successful implementation of a pharmaceutical packaging automation system. The Luciano team can provide the life cycle documents and execution to support the validation of new or legacy packaging machines.

As-Built Documentation If critical documentation, such as electrical schematics or PLC program records is out of date or missing, correct as-built documents can be generated. These are necessary to properly qualify legacy equipment.

Functional/User Requirements Specifications Are the foundation of a good validation, if complete and accurate. The Luciano team has successfully supported our customers with effective specifications that not only provide a model for subsequent qualification protocols but help assure that the expected results of the project are achieved.

Detailed Design Specifications provide thorough information on the hardware, software and networking of computer and electronic systems. Our engineers provide a DDS at the beginning of a project, then revise it to an as-built controls document upon project completion.

Engineering Studies
are often needed to develop acceptable ranges of parameters such as temperature, speed, pressure, etc. at which a packaging process can run reliably. We can develop test protocols and analyze data based on our experience with many packaging processes.

Acceptance and Commissioning Protocols
, if done well, provide the groundwork for successful qualifications. These protocols can be prepared by our experienced staff, and executed. Data may be developed in the execution process that is used in the OQ.

IQ (Installation), OQ (Operations) and PQ (Process) Protocols will be prepared in the customer’s format or in the format developed by the Luciano teams experience with numerous pharmaceutical clients. These qualifications will contain all the elements deemed necessary in current practice.

Protocol Execution by experienced engineers and technicians provides assurance of an orderly qualification process. Our experience enables us to efficiently and accurately complete the qualification process.