Project Definition and Specifications
	As the customer and application development team go through the series of questions to co-develop the system specifications, inevitably more specific questions arise of which may be easily answered or require some actual testing for an answer. Since our expertise is in automation, we rely on the customer to be able to analyze their processes to be optimized. New techniques in such general areas of purification, separation and imaging render quicker and improved process for automation. These processes should be tested for feasibility by the customer long before any commitment is placed on the scope of the project.
Automation Project Management
	Again, the goal of a properly managed automation project is to have no surprises. The first step is the formation of a team of ‘stakeholders’ that must include not only the staff responsible to make the system actual run, but management who will be supporting and measuring the activities of the project. A customer team of ‘hands-on’ laboratory staff in addition to lab management all excited about the implementation of an automated system is initially required for a successful project. On our end, a highly trained group is assembled from the beginning consisting of a Project Leader/Application Engineer, Mechanical Engineer and Service Engineer. This staff works side by side with the Sales Engineer and the customer team. Customer teams may also include IT staff if a large amount of data will be generated, a purchasing agent if many disposables are needed or even a waste management staff if there is to be large amounts of wastes produced from tips, plates or washing fluids.
Functional Requirements Document (FRD)
	The key function of this project team is to create and formalize a Functional Requirements Document (FRD) that will define the operational requirements and scope of the system. It is this document that needs to be completed in order to create a proper quote with system pricing. As the project proceeds forward, it is this document that will be continually updated and agreements will be necessary by all team members if any of these new changes affect the scope and therefore pricing of the system. Cooperation, flexibility and application understanding will be key to success in running a large project like this smoothly. Form examples of the FRD are readily available from our Project Managers to use as a template and can be started with the answers to the Customer Prep Worksheet. Once all the specifications are documented, the Project Manager can estimate the overall project timeline and communicate this to the combined team.
System Quotation
After the Functional Requirements Document (FRD) is completed and agreed upon by the entire Project Team a configuration meeting the requirements may be designed and assembled on the computer. This computer representation gives the team the ability to visualize the solution and start to see how samples will be processed and handed off throughout each functional piece. With the hardware and software defined, a system quote can be generated outlining the investment required to automate the full project.

How do I check the system layout from the proposal?

During the process of automating a method, a system layout created in a line drawing style (CAD) should be submitted and reviewed. During this process, the actual staff that run the method daily should be present to go over every single manual step they perform from the labs Standard Operating Procedure (SOP) document. These steps should be reviewed on how the samples will arrive on the automation system, how each step is reproduced by the system, how the samples or plates get saved or thrown in the trash and finally what data is generated and what happens to it.

Once everyone can visualize each piece of the system and what it will perform, the ‘scope’ of the project is defined and can move forward.

Factory Acceptance Testing

A factory acceptance test (FAT) can be performed, if required by the customer or the application development team, to measure the functionality of a system while it is still at the factory or fabrication/engineering site. This test is pre-determined and documented to run a set procedure using inert materials; since most integration areas are not set up to test the ultimate chemical or biological outcome of the process with the newly programmed methods. Even though most methods are run with water, by doing this, the customer and the application development team may view the system in physical operation in real time. It gives the customer access to the higher level technical resources and even the ‘creators’ of the base units for quick and precise feedback.

Since this operation takes place at the factory with al the engineering and machining facilities, any changes can be accommodated at much less risk and time than if the system was already on site.

If the system is going to be used in a regulated environment, requirements regarding validation, sample tracking, audits, audit trails, electronic signatures, and documentation for software and systems are going to be required by governing agencies. These packages should be discussed from the beginning and are usually the responsibility of the customer.

Installation & Training

Once the system arrives on site, the development team will send one of its team members that packed the system at the factory to the customer site to aid in the final assembly of the system. Since multiple vendors may be required to attend this install for a large customized solution, this process may take a few days to ensure that each piece of the system is fully testing and functioning.

The application development team then will test out the system as a whole and the users are trained directly on the system.

Site Acceptance Testing

Now that the system has been running on site in test mode, the site acceptance test (SAT) commences where the system is run with real samples and reagents. The application development engineers work closely the users to assure that actual chemistries are in order and function to the specifications defined in the initial proposal. During this final step, the users are empowered to take over the system and become the managers of the system.

Once SAT completes, the users that manage the system may in turn train the daily users on running the basics on the system in order to process the daily workload.

How do I assure the results of the system?

As with any method or system, results need to be verified and validated (V&V) against a standard. This standard is defined by each individual company depending on the kind of test that is being automated, general research being the least stringent while in-vitro diagnostic (IVD) tests needing to go through the FDA for acceptance to perform diagnostic test for humans.

In this area, integration systems of this nature are installed in mainly the BioPharma markets not requiring FDA acceptance and therefore requiring only basic validation. This basic validation should be define during the system proposal phase while consulting the company quality control and regulatory departments on to what is going to be necessary to put the system in operation.