Leaderboard 10.6.2025
Leaderboard 10.6.2025

Salt Springs Informatics, Inc.

No reviews yet · Write a Review
Salt Springs Informatics provides individual staff for program/project management, computer system validation, R&D IT, quality systems, compliance, and system life-cycle services - to help life science companies address their unique business, regulatory, and information technology challenges. We deliver C2C consulting with in-depth experience, domain understanding, and system, process, & management execution at the operational, strategic, and tactical level. This includes analysis, design, vendor/solution selection and validation of systems; program governance for system & compliance deployments; delivering on SDLC structures; managing IT projects/organizations; support transitions; and SOW & MSA contract negotiation.

We are often brought in for critical projects that’ve incurred challenges (due to complexity, ambiguity, or vendor issues) and/or which require a broad understanding of life-science processes, information technologies, common vendor dynamics, and robust project management – along with the ability to facilitate discussion/progress across all stakeholders and participants. This includes facilitating MSA negotiation spanning IP, Legal, InfoSec, vendors, Procurement, and Infrastructure.

Our 25 years of life-sciences experience spans across a technology/business spectrum of COTS, SAP, data integration, lab informatics, quality systems, computer system validation, business process improvement, and server/data center build-out & operations for R&D, clinical, drug safety, manufacturing, supply-chain, acquisitions, and surveillance functions with biologics, small molecule, consumer care, and medical device clients. Consulting efforts include global infosec & data-center auditing; drug-product lot review & release systems; medical-device complaint management systems, and managing regulatory compliance and system qualification efforts.

Specialties: Regulatory Compliance, Quality and Drug Product Release Systems, Complaint Management, Laboratory Information Management Systems, Informatics, GxP, Enterprise Resource Planning, System Integration, Business Processes and Analysis, Program and Project Management; Auditing & Audit Remediation; SAP; SM-IDI; SampleManager; STARLiMS, Jira, SAP Solution Manager & Test Organizer, Quality Systems, LIMS, CSV, Document Management & Document Control, CAPA, 21 CFR, Computer System Validation, SOP Development, COTS, Vendor Management, Contract Management, Delivery Management, Service-Now, Support, Adverse Event Reporting, Medical Devices, Biotech, Pharma; MicroFocus ALM Application Lifecycle Management; Quality Management Systems, QMS, Computer System Validation, Training Management Systems, TMS, Learning Management Systems, LMS

Company Details

Address
310 Salt Springs Street
Fayetteville, NY 13066

Competitors of Salt Springs Informatics, Inc.

ProPharma is the premier Research Consulting Organization (RCO), delivering fully customizable consulting solutions to empower biotech, med device, and pharmaceutical organizations of all sizes to advance scientific breakthroughs confidently and introduce new therapies. With over 20 years of... Read More

0 Products 0 White Papers 0 Press Releases

Pharmaceutical Consulting Services in Validation. Valoit Inc. provides FDA and SOX regulatory compliance services, catering primarily to entities within the pharmaceutical, biotech, medical device, and diagnostics industries. With a robust portfolio that spans audit assessments, validation, and... Read More

0 Products 0 White Papers 0 Press Releases

Clarkston Consulting is a different kind of management and technology consulting firm. We deliver a unique experience for market leaders within the Consumer Products and Life Sciences industries. Considering professionalism, expertise, and value as prerequisites, we take service a step further... Read More

0 Products 0 White Papers 0 Press Releases

Categories

Technology > Computer-Related System Validation
Med Rectangle Pharm 2.3.26