Leverage innovation. Improve compliance.

We design and maintain effective Quality Management System frameworks that enable organizations to leverage the latest manufacturing technologies and innovations while congruently improving compliance. Done right, the two functions work in unison, driving operational and compliance excellence.

Operational excellence through integrated quality systems

Pinnaql delivers integrated quality operations and compliance services across pharmaceutical, biotech, and medical device sectors. We combine technical engineers, lab scientists, and QA experts to develop systems that are technically sound, practical to execute, and built for global regulatory expectations.

This collaborative team ensures your quality operations support product integrity, data reliability, and successful inspections—without slowing down your operations.

Engineers overlooking factory floor

Key benefits of partnering with Pinnaql

We’ve structured scalable systems to help reduce risk, support data integrity, and streamline execution across your operations.

01

GxP-driven SOPs, CAPA, and deviation systems

Systems are grounded in how your operations actually work—eliminating recurring issues and improving inspection outcomes.

02

Change control with cross-functional expertise

Engineers, scientists, and QA collaborate to design compliant, scalable, and traceable change control frameworks.

03

Smarter validation & quality engineering

Validation is connected to process performance, not just paperwork—applying Lean and Six Sigma to reduce risk and increase efficiency.

04

Risk management from lab to line

We apply proactive frameworks (FMEA, hazard analysis) to ensure your systems are defensible and aligned with FDA, EMA, and ISO standards.

Our quality operations and assurance solutions

Our Quality Operations & Assurance services are built to close the gap between compliance and execution—so your team can operate confidently and audit-ready.
Laboratory equipment & document binders

Overview

In GxP environments, every deviation, corrective action, and SOP must reflect how your operations actually function—not just what looks good on paper. Pinnaql delivers real-world, risk-based systems designed for clarity, traceability, and audit readiness—reducing repeat issues, improving audit outcomes, and embedding sustainable compliance practices across your teams.

SOPs, CAPA & deviation management

/01

What we do

SOP development & optimization

Create and revise SOPs tailored to manufacturing, QC, R&D, and facilities—aligned with FDA, EMA, ICH, and USP expectations. Designed for usability, enforceability, and operator clarity

CAPA program design & execution

Build data-driven CAPA systems informed by engineering root cause analysis, integrated with QMS platforms (Veeva, MasterControl, TrackWise). Includes effectiveness checks and regulatory defensibility

Deviation management & investigation support

Full deviation lifecycle management—from triage and impact classification to investigation, documentation, closure, and trending. Linked directly to CAPA programs for systemic issue resolution
Scientists collaborating in laboratory

Overview

In regulated lab and manufacturing environments, change is constant—but unmanaged change can create serious compliance risks. Pinnaql designs and implements risk-based change control programs that are compliant, traceable, and operationally practical—ensuring business continuity and audit readiness from proposal to closure.

Change management & control

/02

What we do

Risk-based change control frameworks

Develop scalable, compliant change processes aligned with FDA, EMA, MHRA, and ICH Q10 expectations

Platform-specific implementation

Configure change workflows in Veeva Vault, MasterControl, TrackWise, or custom QMS platforms—validated and aligned with SOPs

CCRB facilitation & SME input

Lead structured CCRB meetings supported by engineering, IT, RA, and lab stakeholders to ensure technical, scientific, and regulatory soundness

Impact assessments & documentation

Evaluate GxP relevance, validation status, data integrity (ALCOA++), and downstream effects for each proposed change
Researchers discussing data on tablet

Overview

Quality shouldn’t stop at compliance—it should drive operational performance. Pinnaql applies quality engineering principles to optimize processes, reduce variability, and improve throughput across labs and manufacturing, all while maintaining full regulatory alignment.

Quality engineering &
process improvement

/03

What we do

Lean six sigma & FMEA application

Improve lab and manufacturing efficiency through structured process analysis and proactive risk mitigation

Process optimization

Enhance performance across batch manufacturing, fill/finish operations, and device assembly lines

Continuous improvement frameworks

Implement sustainable, data-driven quality programs grounded in quality engineering fundamentals
Gloved hands examining petri dish

Overview

Pinnaql delivers end-to-end CQV services to help you launch, scale, or remediate with confidence. We ensure your facilities, utilities, equipment, and processes meet cGMP requirements and operate with consistency, quality, and compliance from day one.

Commissioning, qualification &
validation (CQV)

/04

What we do

Validation protocol development & execution:

Create and perform IQ, OQ, and PQ protocols tailored to your process and product

Specialized CQV services

Validation support for equipment (e.g., bioreactors, lyophilizers), clean utilities (WFI, HVAC), and lab systems (HPLC, stability chambers)

Process & cleaning validation

Full support for aseptic operations, sterile filtration, CIP/SIP systems, and formulation/fill/finish processes

Facility & production readiness

Environmental monitoring, cleanroom qualification, personnel gowning, and storage validation to ensure audit-ready operations
Scientist reviewing data on tablet

Overview

Digital systems are essential—and increasingly scrutinized. Pinnaql helps life sciences organizations validate manufacturing and lab software to meet 21 CFR Part 11, GAMP 5, and global data integrity standards. We bridge the gap between IT and OT to ensure reliable, compliant performance.

Computer system validation (CSV) & digital validation

/05

What we do

Validation planning & execution

Develop and execute validation master plans, test scripts, and protocols for mes, scada, lims, bas, and more

Data integrity & ALCOA++ compliance

Ensure systems meet regulatory expectations for attributable, legible, contemporaneous, original, and accurate data—plus completeness, consistency, and availability

Audit-ready documentation

Provide defensible records of system validation, user access controls, and electronic signature workflows

Proactive risk mitigation

Identify gaps and reduce regulatory risk related to electronic records and software lifecycle management

Why Pinnaql for quality operations & assurance

Built for real-world lab and manufacturing needs

Cross-functional teams across QA, engineering, and science

Deep experience in pharma, med device, and advanced therapies

Seamless fit with your systems, platforms, and workflows

Industries we serve

Pharmaceuticals

Advanced therapies

(Biotech, Radiopharma, CGT)

Medical devices

Compounding pharmacies

Ready to optimize your quality operations?

Let’s build compliant, sustainable systems tailored to your lab or manufacturing environment.

Visit us

101 Lindenwood Drive, Suite 225 Malvern, PA. 19355

Visit us

9800 Crosspoint Blvd, Suite 200, Indianapolis, IN. 46256

Get in touch

(484) 321-3339