Success The Old Fashioned Way - Through Experience.
It’s not just about the software. Sure the software helps us do our job efficiently, and get the results we want, but it’s not just about the software. Solution Systems Inc. (SSI) has learned that it’s Experience that matters. Early on SSI established a methodology that fills in the gaps left by traditional Project Management / Project Execution tools. This methodology has enabled SSI to see through the murky waters of messy Consent Decrees, Technology Transfers and Facilities upgrades.
What does our methodology include that others leave out? People. Our people to be exact. SSI’s goal is to make sure your business succeeds. We strive to understand your business as if it were our own, guiding you along the way. You succeed, we succeed!
Over 29 years of consulting, strategy and Experience.
Here is a snapshot of some of the types of Initiatives we have been involved in:
Quality Remediation Activities
including Consent Decrees, Warning Letters and 483’s. Our work has run the gamut from people on the ground managing and scheduling plans for remediation to managing the overall initiative development from audit observations through successful remediation.
New Product Launch
including multi-site (global) activities to launch new products from Development to Manufacturing and Licensure. While this work is often surrounded by technology transfer activities, we have integrated the method development, equipment qualification, process validation through Submission and PAI readiness.
New Facility Commissioning Through Licensure
really a form of the New Product Launch, we have developed complete integrated plans and execution methodology to bring an entire new facility online. These plans are often the most interdependent in structure and the most complicated.
Plant Reconciliation and Product Transfer
here the emphasis on tracking the work by location, product and sales market. Our methodology allows for the multiple views required by this complex work including the Product Transfer and Regulatory requirements.
Global Quality Initiatives
from software rollouts to Qualification and Process Validation programs and Analytical Method Development and Validation — we have planned and assisted in the execution of the many annual Quality programs. We help our clients regain control of annual budgets that get spent on people while successful completion is often eluded.
The iPlan® consulting methodology provides a significantly greater chance of finishing on-time or early. The methodology is blend of Quality, Manufacturing and Facilities project management experience with advanced knowledge of the existing project management frameworks available today. SSIprovides the “people” and “technical” experience to enhance the probability of a successful outcome for your initiative.