Establish and maintain a Quality Management System (QMS) built for the realities of regulated manufacturing. We align your processes with cGMP, ISO 13485, and FDA expectations—delivering QMS frameworks that are practical, auditable, and sustainable.
From mock inspections and risk assessments to CAPA planning and remediation, we help you navigate FDA requirements with confidence. Our proactive strategies ensure your team is always audit-ready.
Key Focus Areas:
We guide you through the selection, implementation, and optimization of eQMS platforms—ensuring seamless integration with your lab, manufacturing, and QA workflows. Whether you're deploying Veeva, MasterControl, TrackWise, or another platform we make it work for your team.
Benefits:
In the face of litigation or regulatory enforcement, our FDA expert witnesses offer technical credibility, strategic guidance, and clear testimony. We help you bridge regulatory interpretation with engineering and scientific fact.
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Design and implement real-world systems for handling deviations, investigations, and corrective/preventive actions (CAPA). We ensure your documentation meets regulatory requirements—and your teams know how to use it.
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We help you build and manage structured change control processes with strong documentation and cross-functional alignment—so changes are compliant, traceable, and audit-ready.
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Accelerate your path to compliance and product readiness with full CQV execution—backed by deep technical expertise in equipment, utilities, and facilities validation.
Key Areas:
Ensure your manufacturing and lab systems meet 21 CFR Part 11, GAMP 5, and modern data integrity expectations. Our CSV strategies are scalable, defensible, and designed to keep your operations audit-ready.
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From HPLCs to incubators, we handle the full lifecycle—qualification, validation, maintenance tracking, and compliance documentation—for your critical lab assets.
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Reduce internal strain and accelerate lab setup with full-service outsourcing for instrument commissioning, validation, documentation, and ongoing compliance workflows.
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We help labs optimize their LIMS platforms and enforce compliance with 21 CFR Part 11 and ALCOA+ standards—ensuring traceable, secure, and auditable digital data environments.
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We ensure your lab systems and software platforms are fully validated, secure, and compliant—bridging IT, OT, and regulatory expectations for digital operations.
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Deliver projects on time, within scope, and fully aligned with regulatory expectations. We manage capital projects, operational readiness, and site planning with a cross-functional lens.
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Technical depth meets proactive process control. We manage the full lifecycle of manufacturing assets with change control, FMEA, and CAPA integration.
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Ensure your manufacturing systems are compliant and production-ready through end-to-end Commissioning, Qualification, and Validation services.
Key Capabilities:
Validate your automation, MES, BAS, and SCADA systems with confidence. Our CSV services align with ALCOA++ and FDA data integrity expectations across manufacturing platforms.
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We support your Industry 4.0 roadmap with GAMP 5-compliant automation, AI-enabled quality control, and predictive compliance tools.
Future & Available Services:
Nationwide team of life science focused engineers, scientists and QA professionals elevating compliance while simplifying complexity.
GMP, GLP, GEP, 21 CFR Part 11, and ISO 13485 compliance baked into every solution.
Our multifunctional expertise in lab operations, tech services and manufacturing facilitate growth and supports change.
Solutions designed to support your highest priorities and focus within the pharma and med device manufacturing lifecycle.
When you work with Pinnaql, you're not just hiring a vendor—you’re embedding a cross-functional team of engineers, scientists, and quality consultants with decades of experience across the life sciences landscape.
101 Lindenwood Drive, Suite 225 Malvern, PA. 19355
9800 Crosspoint Blvd, Suite 200, Indianapolis, IN. 46256
