GxP Compliance & 21 CFR Part 11 Validation
PSI helps pharmaceutical and life sciences organizations accelerate R&D and ensure GxP/21 CFR Part 11 compliance. Secure your IP and validate your cloud with a proven Microsoft Tier-1Cloud Solution Provider.
Accelerate discovery, ensure GxP compliance, and protect your intellectual property. PSI delivers validated, secure, and intelligent cloud solutions built on the Microsoft platform—engineered specifically for the rigorous demands of pharmaceutical and life sciences organizations.
The pharmaceutical and life sciences industry operates under a unique dual imperative: innovate at unprecedented speed while maintaining perfect, provable compliance. The pressure to accelerate R&D and clinical trials is immense, yet the risk of a single compliance failure is catastrophic.
Your operations are governed by GxP(Good Manufacturing/Clinical/Laboratory Practices) and FDA 21 CFR Part 11. These stringent regulations for electronic records and signatures mean that "data integrity" isn't an IT buzzword—it's a legal and business necessity that can make or break regulatory approval.
To remain competitive, you're adopting cloud platforms for core Quality Management Systems (QMS), Laboratory Information Management Systems (LIMS), and ERP systems. You're leveraging AI to optimize manufacturing and high-performance computing to power drug discovery, all while managing increasingly complex data workflows.
Your data is your most valuable asset. The theft of clinical trial data or novel drug formulation IP represents an existential threat, often from sophisticated, state-sponsored actors. Your complex digital supply chain creates additional vulnerabilities that demand constant vigilance.
This creates a central, high-stakes question for IT and Quality leaders: How do we successfully execute a Pharmaceutical IT Modernization plan while proving validation to an FDA auditor? How do you ensure the data it produces is trustworthy and compliant with 21 CFR Part 11?
This requires a partner who understands not just technology, but auditable quality processes.
We provide the secure, compliant, and validated modernization services you need to accelerate your pipeline. Our core capabilities map directly to the GxP-regulated challenges you face.
Migrating GxP-regulated systems (QMS, LIMS, ERPs) to the cloud is not a simple "lift-and-shift." You bear full responsibility for system validation, data integrity, audit trails, and proving that electronic records and signatures are authentic and trustworthy per 21 CFR Part 11.
We are your validation and modernization partner—where our core credentials become your greatest asset.
The regulatory landscape is clear: there is no "GxP certification" for cloud service providers. Microsoft provides GxP guidelines and foundational audits (ISO 9001, ISO 27001), but your organization remains 100% responsible for validating your specific solution.
We are CMMI-Level 3andISO 9001 certified. We operate on a foundation of defined, documented, and mature quality management processes. We bring this auditable process maturity to your cloud migration, providing the documentation, validation protocols, and change control required to satisfy auditors and meet 21 CFR Part 11 requirements.
We leverage our Business Modernization and GRC expertise to re-engineer your systems for the cloud, following Microsoft's GxP guidelines to ensure data integrity, audit trails, and access controls are built-in from the start.
R&D bottlenecks and inefficient clinical trial management are the biggest barriers to revenue. Your research teams need massive, scalable computing power for modeling, while your clinical operations teams struggle with slow, error-prone, and costly manual data reconciliation processes.
We deploy the intelligent Microsoft platform to automate workflows and power discovery.
As Azure experts, we design and manage scalable Azure HPC environments, giving your R&D teams virtually unlimited compute power for genomics, molecular modeling, and AI-driven drug discovery—accelerating your time-to-market.
We leverage our Data & Operations Modernization expertise to transform your clinical workflows using the Microsoft Power Platform
Automated Data Reconciliation: Power Automate solutions that compare mapped fields, flag discrepancies between EDC systems and trial data, and generate reports—proven to transform clinical trial operations
Audit-Ready Data Extraction: Automated creation of standardized, compliant PDF reports with secure metadata and storage
AI-Powered Insights: Leveraging AI models to identify suitable trial patients from aggregated data or assess trial site performance in real time
Your intellectual property—drug formulations, research data, and clinical trial results—is your most valuable asset and a primary target for cybercriminals. Your increasingly digital supply chain creates additional vulnerabilities, with third-party vendors and contractors introducing significant, often unmonitored risk.
We implement a Zero-Trust security posture to protect your assets from lab to patient.
Our Business Modernization service includes designing and implementing Zero-Trust Cybersecurity Frameworks. We use Microsoft's security stack (Defender, Intune, Azure AD) to enforce "never trust, always verify" principles, protecting your data from internal and external threats.
We deploy advanced encryption for data at rest and in transit, data loss prevention (DLP), and granular access controls to secure your data across M365, Azure, and hybrid environments.
Our GRC and cybersecurity services extend to your digital supply chain. We help you assess, monitor, and govern third-party risk to ensure your partners don't become your biggest liability.
AI promises to revolutionize drug production and R&D, but it introduces a "black box" that's difficult to validate for GxP compliance. "How do I prove my AI is compliant?" has become a critical question for quality and IT teams.
We are your partners for AI Readiness, helping you navigate this new landscape safely.
We help you distinguish between AI as a "job aid" versus an "autonomous system"—a critical distinction that dictates your validation approach.
We leverage our GRC and CMMI-Level 3 process expertise to help you build the Standard Operating Procedures (SOPs), risk management frameworks, and training programs required to adopt AI in a way that's explainable and defensible to auditors.
We deploy AI solutions within your secure, governed Azure environment, leveraging our proven AI implementation experience as demonstrated by our own AI platforms.
Critical risk of data integrity findings, failed audits, and delayed regulatory approvals. Inability to validate cloud systems.
GxP-aligned cloud migration for QMS/LIMS, leveraging CMMI-Level 3 & ISO 9001processmaturity for auditable validation and comprehensive documentation.
Existential threat from loss of research data, drug formulations, or clinical trial results to competitors or malicious actors.
24/7/365 U.S.-based SOC and Zero-Trust security operations using Microsoft Defender, Intune, and ISO 27001-certified controls.
R&D bottlenecks slow time-to-market. Manual clinical data reconciliation is slow, costly, and error-prone, delaying critical milestones.
Azure HPC for computational research and Power Platform automation for clinical trial data reconciliation, reporting, and analytics.
Security breaches from third-party vendors and contractors. Potential disruption to manufacturing and distribution operations.
GRC modernization for third-party risk management and robust network security to protect digital supply chain integration points.
You cannot trust your IP and GxP systems to just any IT provider. You need a partner whose own processes are as mature and auditable as your own.
This is our most critical differentiator for life sciences organizations. Your organization is responsible for GxP validation, even in the cloud. You need a partner with an auditable Quality Management System (QMS).
Our ISO 9001 certification is that QMS certification—externally audited and verified.
Our CMMI-Level 3 certification proves our engineering and service delivery processes are defined, documented, and proactive.
We are ISO 27001:2013 certified. Our Information Security Management System (ISMS) is independently audited and verified, providing baseline assurance for protecting your high-value intellectual property and clinical data against breaches.
As a MicrosoftTier-1 CSP, we don't just sell licenses—we are experts in implementing solutions using Microsoft's GxP guidelines for Azure. We build compliant, validated systems on a platform with proven enterprise reliability.
Your mission-critical R&D, manufacturing, and quality systems are monitored around the clock by our U.S.-based engineering and security teams, ensuring rapid response and compliant access controls every day of the year.
The future of life sciences belongs to those who can innovate within a framework of absolute trust and integrity. Partner with PSI to build your validated, secure, and accelerated path to discovery.
PSI enables seamless cloud transitions with Microsoft 365, Azure, and Marketplace solutions—offering scalable tools to modernize infrastructure and drive digital transformation.
We are not just a Microsoft reseller; we are a fully integrated, direct-bill partner providing Microsoft Cloud Consulting with deep, proven expertise across the entire Microsoft ecosystem. While other firms may specialize in one or two pieces, we engineer end-to-end solutions that span infrastructure (Azure), workforce modernization (Microsoft 365), and data transformation (Power Platform). This full-stack capability is central to our Strategic IT Consulting, enabling us to build, secure, and manage a truly unified digital backbone that maximizes your Microsoft investment.
We believe Client-Centric Digital Transformation isn't a transaction—it’s a partnership. We don't provide generic, "textbook" answers. Instead, we take the time to understand your mission, your people, and your unique challenges before we design a solution. We assess your real-world factors, from corporate culture to your team's technology competency, to design and deliver solutions that are not only innovative but also practical, ensuring successful Technology Adoption across your organization. Our solutions are built to be adopted by your team and to evolve with your business.
Our success is measured by your sustained performance and Sustainable Growth, not by the length of our engagement. We are committed to genuinely doing the right thing for our clients, which means our primary goal is to empower your workforce through Knowledge Transfer, rather than create long-term dependencies. We blend enterprise-grade capability with the precision and direct access of a small business, ensuring you get transparent communication and solutions that enable you to operate smarter, faster, and more securely long after the project is complete.
Unlike large, high-volume integrators, PSI operates with agility and a focus on quality. We blend enterprise-grade capability with small business precision. This means you get creative, effective solutions without over-complication or bureaucracy. Every engagement is guided by Senior-Level Expertise and strategists who work hands-on, giving you faster decision-making, and a solution that is simple, powerful, and built for your specific needs.
See How PSI Helps Organizations Modernize, Secure, and Transform Their IT Operations.
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