SysComm is established as a leader in the Project Management of Life Science capital construction and equipment procurement.
We are a flexible, client-focussed organisation capable of supplying direct project management services as part of a Life Cycle Management provision, or as a Stand-Alone service.
We can work equally assured within our client’s project management infrastructure, or alternatively, we can deploy our own complete set of project management tools, whichever you deem appropriate.
Our project engineers and managers have a precise understanding of the nuances associated with achieving successful project closure in a regulated environment.
Therefore, if you believe:
- your project is at risk of losing control;
- or that you have lost focus on what you need to do, to actually get to the end of the project;
- or that there are many opinions circulating, but no clear direction to get to the end of the road;
we can help!
We possess a deep understanding of what is truly required to achieve effective project completion in a safe and compliant manner.
We excel at guiding our clients through their world, especially when that world is in an abyss.
We achieve this by being the best at what we do; by simplifying the complex, and; by collaborating deeply with our client’s team to meet their goals and create new value.
Life Cycle Management
Life Cycle Management (LCM) involves the complete understanding of your requirements, verifying them and managing them through the complete project life cycle – up to the end of your successful audit.
In SysComm, we believe that projects are all about achieving successful change over the life-cycle of a project and that managing change is about managing processes, engaging people and providing clear signposts along the way.
By understanding our client’s requirements up-front, managing these requirements through the ever-changing stages of a project and communicating effectively with our client – success can be achieved.
SysComm’s preferred approach is to manage the delivery of systems through procurement, construction and verification phases of the LCM. We do this in a manner which is fully traceable, focusing on criticality (risk) and maximises the re-use of vendor data in the verification process.
In this approach, our default is to use a blended team model; integration of the client and SysComm project team. This enables the scaling of the project team in a cost-effective manner, whilst ensuring maximum knowledge creation and retention by the client system owners.
SysComm LCM services are fully scalable; ranging from a focussed over-watch role ensuring compliance to URS or FDA/Eudralex Regulatory norms, up to a full team capable of delivering any combination of GEP/GxP management services, including if necessary, taking on the management of the complete project.
As with all SysComm services, our goal is to help our clients reach their destination and achieve their project goal – the delivery of correct, effective, safe and audit-ready systems.
Commissioning and Qualification
SysComm can pick up a C&Q programme at any stage of the Project’s lifecycle and deliver it to a successful completion for our client.
We are comfortable working with Internal client processes; external contractor procedures, or indeed; our own custom procedures. Regardless of the processes, we will always deliver excellent, audit ready systems which comply with regulatory norms.
This is due to the quality of our personnel, their level of knowledge and their deep understanding of the principles of verification, not merely what the SOP says or what the checklist demands. Our client-centred, outcome-focussed approach, whether solely in commissioning or qualification or both, ensures we will always carry out our tasks with the audit and final application in mind, and in the complete belief of what is truly important – the patient at the end of the process.
SysComm’s services are designed to be flexible – we do what is required at any one time to ensure that you arrive at your final destination. This flexible approach ensures we can deliver successful projects, from shutdown upgrades to new facilities.
With SysComm, you can rely on a team with experience in MedTech, In-Vitro Diagnostics, Sterile Fill Finish, Solid Dosage and API Facilities.
Our Core Competencies are:
- Subject Matter Experts
- Commissioning & Qualification Consultancy
- Commissioning & Qualification Strategy Planning
- Governance Documentation
- Traditional and Risk Based Approaches
- Project Management of C&Q Projects
- Construction Turnover & Construction Quality
- Generation of C&Q Templates
- Factory Acceptance Testing
- Generation of C&Q Protocols
- System Shake-Down, Start-Up and Field Test Execution
- Post-Execution Reports
- Sterilisation Validation
- Compliance with Regulatory requirements