Why Choose Salt Springs Informatics?

We have one measure of success: your team / effort accomplishing its goals.

We don't sell software or solutions.  We provide expertise, discretion, experience, energy, and drive - in the form of project staffing.  We've demonstrated the ability to consistently deliver results no matter what the circumstance and context, throughout the life-sciences product life-cycle: in biologics, pharma, med device, & consumer packaged goods; from R&D solutions, analytical labs, product release, and post-marketing surveillance.

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Case in Point: Quality System & GxP ERP implementations

 

QMS and GxP efforts often bring many challenges:

• Over-allocated Quality and Operations staff (with a day job of getting product out the door), often wrestling with a new technology and what it means for their world.

• Vendors with varying levels of understanding of exactly what “GxP” and “CSV/CSA” means, or how it applies to their documentation.

• Diverse stakeholders/departments/vendors, who need a common understanding of environments and delivery cycles/events to define validation approach, testing scrutiny, and documentation.

• GxP data being migrated, some with significant transformations, all of which need to be understood, blessed, and verified.

• The need for a well-articulated vision / diagram of the As-Is and To-Be business/quality processes.

• Project schedules that must include all GxP tasks/deliverables and their dependencies to avoid schedule surprises.

• An effective / efficient validation/assurance approach is needed to contain costs, effort and focus on risks in order of priority

• Out-dated validation approaches, applied to large-scale implementation can result in non-value-added activity

• A strong understanding of the key risks in technology / process transformations is needed for an effective & efficient qualification strategy.

• Implementations touch many environments and vendors, but still require a cohesive and robust validation/qualification package

 

Nothing beats experience and understanding to help ensure success.

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You need someone who’s fluent in a spectrum of technology stacks / infrastructure, in data migration and ETL, and in a wide range of quality/business processes (spanning multiple life science industries) and who can be instrumental in helping you de-risk your efforts, get ahead of issues before they present themselves, and provide for a “north star” of program management, validation approach, and project deliverables / dependencies.  This makes for less churn, and more focus on executing well-defined & clearly-communicated goals/deliverables.

 

This requires several key competencies:  the ability to effectively model and communicate complex topics, an understanding of the constraints and quality/business-drivers of life-science clients, and a nuts-and-bolts understanding of the technologies/integrations that are in play.  Key also is being able to listen pro-actively and develop/paint a picture of “the world of tomorrow” for a system (and what’s possible to make tomorrow a better place), and being forward-looking enough to recognize potential issues/gaps.

 

This is where being able to tap into the right resource can make or break your effort, timelines, CSV/quality artifacts, and overall implementation.  You need a resource who can:

• capture all applicable tasks for an effort, foresee likely risks and recommend best practices / innovations, and drive the project completion – even in challenging circumstances and schedules.

• define and drive an effective & efficient validation approach / structure

• work with vendors and internal service organization to capture the environment variables and their delivery steps

• assist business and quality staff to clearly define testable requirements and structure effective and efficient scripts to robustly verify those requirements

• augment/support business analysts, DBAs, infrastructure specialists, IT CSV and QA staff, or program/project managers. 

• help client assess vendors and their products

• remediate outstanding findings / compliance weaknesses

• optimize testing approach/logistics to minimize effort and maximize testing value

• guide prospective solutions to maximum innovation and data-utilization

• function as a drag-and-drop resource on life sciences projects, by virtue of having implemented a full spectrum of solutions across the drug-delivery life cycle across most life-cycle industry sectors, in roles spanning business-process reengineering, product-development delivery, AMS/run, program/project management, remediation, overall compliance, and solution-architecting.

 

How we came to be.

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Salt Springs Informatics was formed 7 years ago to provide exactly that specific skill-set, experience, and demonstrated results.  As consultants, we’ve been helping clients exceed expectations for more than three decades.  Contact us today to see how we can help you succeed with your efforts.