The actual solution assembly, normally called implementation, runs from requirements analysis to successful testing. Each stage is led by an experienced consultant with supporting and qualified resources, including where appropriate from the customer. This is about achieving the objectives for the system.
Requirements need to translate into a build and the first stage is the requirements analysis. A prerequisite is to have requirements documented. Orbis provides our customers with a Requirements Template for this task. These requirements are supplemented and contextualised with current state process and data flows. A series of workshops with subject matter experts and the LIMS team to analyse these requirements using to the chosen LIMS technology to illustrate possibilities. The output from the exercise is a Requirements Trace Matrix (RTM) and/or a Project Backlog.
Design is the process that takes the RTM/Backlog and determines how these requirements will be addressed using the LIMS. This is documented in a Functional Specification and a micro plan to the build the system. At the same time the lead consultant will configure the core system for the build.
Orbis Labsystems uses a Build and Show approach through which the subject matter experts and LIMS team can see and assess the build as it evolves. We believe that this agile and interactive approach ensures that details are captured and consequential business change is understood in advance of solution deployment.
Testing a build is vital both for solution acceptance and reliability. Orbis Labsystems executes testing at up to three levels: functional, systems and qualification. Functional testing is undertaken by Orbis before release of the configuration for training and testing by the customer. This Functional Acceptance Testing ensures that functions as described in the functional specification works as described and is robust. After installation into the customer environment the customer LIMS team is given training for testing. This customer testing is Systems Acceptance Testing and is based on a Test Matrix that we provide. The matrix marries the different sample and testing lifecycles with the configured functionality.
For compliance Orbis Labsystems provides a comprehensive validation program consisting of Installation Qualification (IQ), Operational Qualification in a validation instance and a Performance Qualification (PQ) in either the validation of production instances. Orbis qualifies the installations in each of the controlled environments, validation and production, and will operationally qualify any high risk functionality, such as interfaces and/or extended functionality. The performance qualification follows the operation of the system. The Test Matrix and the user written standard operating procedures (SOPs) guide the scope of the PQ. Orbis provides a PQ Template.
Master Data can be built following training by the customer or by Orbis. This data needs Data Risk Assessment to define the master data build and verify process. In addition to defining the process with supporting SOPs with the customer, Orbis can provide tools for data migration from spreadsheets or legacy systems.
Finally the configured solution needs to go live and handed over to support. Go live is carefully planned with a detailed cut across plan. Each system is documented with a Configuration Specification that describes how the system has been built. This document with handover training/documentation and critical care handholding from the original Orbis LIMS team ensures a smooth transition.