Home

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.

Over 29 years of consulting, strategy and Experience. 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!

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.

Benefits

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.

iPlan® Application Note

Challenge: Integrated Regulatory Remediation

Traditionally, in the world of pharmaceutical or production line modifications separate projects were created for:

Global Regulatory Filings
Operations:
Process Validation
Stability
Cleaning Validation
Test Methods
Compendia
Regulatory Remediation Activities

All of these projects were worked on within separate "silos" of responsibility. Management believed that planning within each silo was challenging enough. Planning across silos, even when interdependencies existed, was seen as almost impossible. Tracking the execution of the plans at any level of detail below the Monday morning staff meeting was seldom contemplated.

Even within an individual silo, the planning activities have historically been kept to a relatively high level because detailed plans were difficult to create and almost impossible to keep updated. Unfortunately, these high-level plans are typically not sufficient to execute the project, and much of the process detail is kept within the recourses responsible for the work. The work was tracked in large chunks or blocks. The monitoring of progress toward the completion of the blocks of work was subjective and often not very accurate. Worse yet, the process of manually "rolling up the dates" that tracked progress within a silo and for the entire initiative (between and above silos) was fraught with problems, inefficiencies and interpretation.

The chaos that resulted made regulatory filings late and sales placed in jeopardy.

The iPlan® Solution:

Applying iPlan® to an application such as this Integrated Regulatory Initiative, allow high-level management review of the planning process while optimizing the likelihood that execution of the plans will happen in a timely fashion. Detailed planning and execution enhances the probability of finishing the correct work on time while self-reporting and automatic summarization and rollups allows multiple levels of management to see the initiative at their respective levels of responsibility. The date rollups are automatic – no manual high-level plan with subjective reporting. Only the truth is reported.

The iPlan® dashboards allow for views by Product, Market, Manufacturing Site and Project Type – all based on the same work reporting. The dashboards are all online and updated with new actual and projected dates as the Tasks are updated.