Services

Based on our comprehensive experience in full life-cycle implementations of systems for the Life Sciences industry, we can provide a wide range of integrated services from Initial Analysis to System Maintenance.

• Business Analysis

An important first step to any project is the analysis of the business processes to determine where improvements can be made to improve flexibility and efficiency.  The goal is to eliminate non-value add activities that will reduce the effectiveness of automation.  The deliverables for this phase is an as-is process flow model along with recommended improvements based on our knowledge of effective automation strategies.  This supports our overall goal of providing our customers an efficient and cost-effective solution.

• Requirements Specification

Once the business processes are optimized, detailed system requirements are developed that specify what the system must do to support the business processes.  The deliverable for this phase is a requirements specification 

• System Design

In this phase, the entire system is designed at a high level.  This design is then broken up into manageable components to facilitate and complete the detailed design.

We understand that the design of any solution requires careful consideration of existing manufacturing systems to achieve a comprehensive solution.  Existing systems are carefully considered during this phase to achieve maximum efficiency.

• System Configuration and Development

This phase includes a broad range of tasks that vary in complexity depending on the level of customization required.  We have the skills and expertise to handle the entire spectrum of solutions from configuring off the shelf systems to creating innovative custom software to meet the system design.

We believe that an important attribute of this phase is step-wise refinement through prototyping.  Prototyping provides feedback to the stakeholders and helps keep the project on track.  The deliverable for this phase is a complete set of working code modules.

• Validation protocol development and execution (IQ, OQ, PQ)

From our years of experience working in the life science industries, our consultants have developed a deep understanding of cGMP and GLP as well as 21 CFR Part 11 regulations.  Based on this, we can provide protocol development and execution services for all stages of the formal testing methodology.

• Systems support and Maintenance

After the solution is implemented, we can provide continuing support and maintenance.  Based on our comprehensive experience supporting systems in zero-downtime, regulated environments, we can meet stringent SLA's. Our system maintenance philosophy is to go beyond issue resolution by providing our clients with root cause analysis to prevent issue re-occurrence.  Early in this phase, we can define specific reporting metrics that allow us to monitor progress toward eliminating the root causes.