Management of a Process Upgrade, a new Control System Deployment or any allied project requires specialised knowledge. This page will refer to the GAMP® lifecycle that is essential for pharmaceutical projects (and can be deployed on non-pharmaceutical projects) to provide a level of assurance that the project will be completed on time and on budget. Please click here more details on GAMP®. Non-GAMP® project frameworks are also supported.

We ensure that adequate User Requirements are in place. User requirements is the most important factor in a project. If the "mission" is not correctly documented then "mission creep" is the likely result along with scheduling problems, cost overruns and tremendous embarrassment to project team members. An adequate user requirements specification that is signed off by the project's senior steering team (principally by the end user, but also by key suppliers) is the keystone of a well-managed project. The GAMP® model defines how to write a URS.

We ensure that the Roles and Obligations are clearly defined. No grey areas in the development and implementation can be tolerated. Contractors must manage their sub-contractors. There should be no doubt as to who is doing what, how much it will cost and when it will be completed. Adequate documents must exist along with Gantt Charts (or similar tools). Milestones must be in place and appropriate actions taken in case a milestone is about to slip or has slipped. Dates and conditions for which at which pieces of equipment, sub-systems or the end system become the property of the "final owner" must be clearly spelled out. The roles and obligations can be documented within the GAMP® lifecycle. Finally, a suitable means must be in place to follow-up on suppliers who do not fulfill their roles and obligations. Project Charters, if applicable are written up.

We ensure that Testing is comprehensive and documented - with end-user approval (areas that cannot be tested are agreed to during the project development). Testing must be completed on time. Quite often (especially in larger projects) delays in building construction, piping or other factors (including budget shortfalls) might mean that adequate testing time is overlooked. The impact of inadequate testing is simple as items not tested and fixed at the factory take longer to fix - causing longer delays than if the testing was completed according to the original schedule. If the decision is made to curtail testing (at the factory or on site), then the ramifications of the decision must be clearly laid to avoid legal issues in the years to come.

We ensure that Training/Support expectations are in place including reasonable orientation for the end users' team. If the end user elects to support the system "in house" after the commissioning and start-up are complete then they must have adequate training. The warranty exclusions must take into account the effects of inadequate long-term support.

We will help you get a project plan in place that adequately protects both the supplier and the end user.