GxP-COMPLIANT END-TO-END ENGINEERING

Lifecycle Engineering for Regulated Manufacturing

From concept design to commissioning, qualification, and audit-readiness — IKE delivers structured CQV, process automation, and compliance execution aligned with EU GMP Annex 15, 21 CFR Part 211, GAMP 5, and ISPE Baseline Guide Vol. 5 for pharma, biopharma, and clean manufacturing environments

GxP Regulatory
Compliance
ASTM E2500
Risk-Based Validation
Operational &
Process Excellence
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360°

Engineering Lifecycle Support

GxP

Compliance-Driven Execution

CQV

Commissioning & Validation Expertise

ROI

Efficiency, Risk Reduction & Control

Engineering consulting
IKE Precision-led engineering for complex regulated operations.
Who We Are

Engineering with Purpose, Compliance, and Measurable Performance

Infinity Katalyst Engineering (IKE) is a specialized engineering and consulting firm serving regulated industries — biopharma, pharma, food processing, medical devices, and clean manufacturing — where product quality, process control, and documentation integrity are non-negotiable regulatory requirements. We support facilities from User Requirements Specification (URS) through commissioning, qualification (IQ/OQ/PQ), computer system validation (CSV), and operational handover.

Our methodology is anchored in ISPE Baseline Guide Vol. 5, ASTM E2500, GAMP 5, and ICH Q8–Q10 guidelines — delivering practical, risk-based, documentation-driven execution that withstands FDA, EMA, and CDSCO inspection scrutiny.

FDA / EMA / CDSCO Regulatory Expertise
V-Model End-to-End Delivery
ALCOA+ Audit-Ready Documentation
ISA-88 Process Excellence
Our Integrated Engineering Services

Regulation-Aligned Engineering Services That Drive Compliance & Performance

IKE delivers structured CQV, automation, and compliance services for regulated manufacturing facilities — executed under ISPE, GAMP 5, ICH, and FDA/EMA frameworks for reliable systems, GxP-ready documentation, and audit-confident operations.

Commissioning, Qualification & Validation (CQV)

Risk-based IQ/OQ/PQ execution per ASTM E2500 and ISPE Baseline Guide Vol. 5. Covers FAT, SAT, DQ, qualification planning, protocol authoring using ValGenesis/TrackWise, traceability matrices, and validation summary reports for upstream/downstream equipment, utilities, and process systems.

Process Optimization & Operational Excellence

Deviation root cause analysis, bottleneck identification, process mapping, SEEQ-based performance monitoring, and practical engineering interventions to improve throughput, consistency, and yield across bioreactor, chromatography, TFF, and CIP/SIP operations.

Regulatory Compliance Support (FDA, EMA, CDSCO)

Gap assessments against 21 CFR Part 211 & 11, EU GMP Annex 11 & 15, and ICH Q7–Q10. Covers SOP authoring, quality system alignment, CAPA management, and inspection-readiness preparation for internal and external audits.

Computer System Validation (CSV) & Data Integrity

End-to-end CSV lifecycle for DCS/SCADA platforms including DeltaV, PCS7, and ABB 800xA. Includes GAMP 5 category classification, CSA, risk assessment, IQ/OQ/PQ protocols, ALCOA+ alignment, audit trail review, and 21 CFR Part 11 compliant digital workflow validation.

Process Automation & Control Strategy

ISA-88 batch automation design, recipe and phase creation, control loop and interlock review, DCS functional specification authoring, and HMI/SCADA integration for DeltaV, PCS7, and ABB 800xA platforms in upstream and downstream biologics environments.

Integrated Engineering & Lifecycle Support

Full-lifecycle execution from URS and DQ through commissioning, SAT, handover, and sustained operations support. Includes P&ID review, valve matrix development, facility fit analysis, technology transfer documentation, and cross-functional team coordination for greenfield and brownfield projects.

Critical GMP manufacturing engineering capability
Core Capabilities

Built for Critical GMP Manufacturing Environments

Lifecycle Engineering Governance (V-Model)

URS authoring through DQ, IQ, OQ, PQ, and process validation — structured per ISPE Baseline Guide Vol. 5 and ICH Q8/Q9/Q10. Includes risk assessment using FMEA, qualification strategy development, and controlled handover documentation aligned with EU GMP Annex 15.

Validation Master Planning & GxP Documentation

Validation Master Plans, qualification protocols, traceability matrices, deviation investigation reports, validation summary reports, and CAPA records — authored to withstand FDA 21 CFR Part 211, EU GMP, and CDSCO inspection review. Delivered via ValGenesis and TrackWise eVLMS platforms.

Utilities, Cleanrooms & Critical GMP Systems

Commissioning and qualification of WFI/PW systems, clean steam, HVAC, compressed air, cleanrooms ISO 5–8, process utilities, and controlled environment monitoring — covering IOQ and periodic requalification per USP <1231>, ISPE Good Practice Guides, and ICH Q7.

Operational Excellence & Continuous Improvement

Process mapping, cycle time analysis, SEEQ-driven performance monitoring, deviation trend analysis, productivity improvement programs, and engineering-based root cause resolution for upstream bioreactor, downstream chromatography, TFF, and CIP/SIP unit operations.

Our Execution Method

A GxP-Structured Engineering Delivery Framework

Every IKE engagement follows a structured, regulation-aligned route — from requirements capture and gap analysis through commissioning, qualification, and sustained operational performance. No isolated activity. No undocumented step.

01
Assess

Gap analysis against URS, applicable regulations including FDA 21 CFR, EU GMP Annex 15, and ICH Q8–Q10, process risk identification using FMEA/FMECA, facility constraint mapping, and qualification scope definition per ASTM E2500 and ISPE Baseline Guide Vol. 5.

02
Design

Validation Master Plan development, DQ and FS documentation, ISA-88 automation strategy, commissioning test plan matrix, traceability framework, and qualification protocol templates aligned with GAMP 5 lifecycle principles.

03
Execute

FAT, SAT, IQ/OQ/PQ protocol execution, CSV lifecycle management for DeltaV, PCS7, and ABB 800xA, automation recipe and phase testing, punch point resolution, deviation management, and documentation control using ValGenesis and TrackWise platforms.

04
Sustain

Controlled handover with training records, ongoing SOP maintenance, periodic requalification support, audit-readiness reviews, CAPA closure, and SEEQ-based operational performance monitoring for continuous improvement.

Industries We Serve

Regulatory-Grade Engineering Across Regulated Industries

IKE deploys industry-specific engineering and compliance frameworks — ensuring that qualification strategies, documentation standards, and automation approaches are precisely aligned with the regulatory landscape of each sector.

Biopharmaceuticals
Biopharmaceuticals (Upstream & Downstream)

Full CQV lifecycle for bioreactors, TFF/UF-DF skids, chromatography systems, CIP/SIP, and buffer management. ISA-88 recipe automation for DeltaV, PCS7, and ABB 800xA, with EU GMP Annex 11 & 15, 21 CFR Part 211 & 11, GAMP 5, and ICH Q7–Q10 compliance for Mabs, therapeutic proteins, and biosimilar campaigns.

Pharmaceuticals
Pharmaceuticals (API & Formulation)

Equipment commissioning with IQ/OQ/PQ, CSV for DCS/MES/LIMS platforms, deviation reduction, CAPA management, SOPs, process control optimization, and inspection-readiness documentation per 21 CFR Part 211, ICH Q8, and WHO GMP guidelines.

Food Processing and Nutraceuticals
Food Processing & Nutraceuticals

Hygienic design review, process optimization, HACCP-aligned process control, GMP documentation, equipment qualification, utility commissioning, and quality system support per FDA 21 CFR Part 117 FSMA, ISO 22000, and FSSC 22000 frameworks.

Medical Devices
Medical Devices

Controlled environment ISO 5–8 cleanroom qualification, IQ/OQ/PQ for manufacturing and sterilization equipment, process validation per ISO 13485, 21 CFR Part 820 QSR/QMSR, and MDR/IVDR documentation systems.

Clean Manufacturing and Facilities
Clean Manufacturing & Facilities

Greenfield and brownfield commissioning for WFI/PW systems, HVAC, compressed gases, clean steam, and cleanroom environments. Qualification per ISPE Good Practice Guides for Water & Steam and HVAC, USP <1231>, and EN ISO 14644 cleanroom standards.

Regulated GMP Engineering
Regulated GMP Engineering

Cross-sector support for qualification strategy, lifecycle documentation, automation alignment, data integrity, audit readiness, and sustained operational compliance across highly regulated manufacturing facilities.

Biopharmaceuticals
Pharmaceuticals
Food & Nutraceuticals
Medical Devices
Clean Manufacturing
Why Choose IKE

Your GxP-Competent Engineering Partner

We combine multi-platform DCS expertise, V-model qualification discipline, and multi-regulatory fluency — delivering engineering execution that reduces project timelines, prevents audit findings, and builds inspection confidence across FDA, EMA, and CDSCO regulated environments.

What IKE Is

Infinity Katalyst Engineering is a specialized engineering and consulting firm serving regulated manufacturing industries including biopharma, pharmaceuticals, food processing, medical devices, and clean manufacturing — where product quality, process integrity, and documentation accuracy are regulatory requirements.

What IKE Does

We partner with manufacturing facilities at every stage of their engineering lifecycle — from initial concept and design qualification through commissioning, validation, automation, and operational handover. Every engagement is structured, documented, and executed to meet FDA, EMA, and CDSCO expectations.

How IKE Works

Our methodology is anchored in globally recognized standards — ISPE Baseline Guide Vol. 5, GAMP 5, ASTM E2500, and ICH Q8–Q10 — delivered through a risk-based, science-driven approach that reduces qualification timelines, prevents audit findings, and supports inspection confidence.

IKE's Commitment

We do not treat engineering and compliance as separate disciplines. At IKE, technical execution and regulatory accountability are inseparable — because in a GxP environment, how you build something is just as important as what you build.

Compliance & Quality Focus

ALCOA+-Compliant, GxP Documentation-Driven Engineering

In regulated manufacturing, documentation is not an afterthought — it is the engineering deliverable. Every IKE protocol, report, and record is authored to satisfy FDA 21 CFR Part 11, EU GMP Annex 11, and ALCOA+ data integrity principles, ensuring that your facility's documentation withstands the most rigorous regulatory inspection.

GxP Validation Documentation Suite

Full protocol and report authoring: Validation Master Plans, DQ/IQ/OQ/PQ protocols, FAT/SAT test scripts, traceability matrices, deviation investigation reports, change control documentation, and Validation Summary Reports — structured for FDA 21 CFR Part 211, EU GMP Annex 15, and ICH Q10 compliance. Executed via ValGenesis eVLMS and TrackWise.

Data Integrity & ALCOA+ Compliance

CSV lifecycle management including CSA, URS, risk assessment, and IQ/OQ/PQ for DCS platforms such as DeltaV, PCS7, and ABB 800xA. Covers GAMP 5 software category classification, access control review, audit trail verification, electronic signature compliance, and compliant digital workflow validation per FDA 21 CFR Part 11 and EU GMP Annex 11.

Science and Risk-Based Qualification

FMEA and FMECA-driven risk assessments to define Critical Quality Attributes, Critical Process Parameters, and qualification scope. Includes qualification strategy documents, risk registers, and science-based justifications for reduced IQ/OQ scope — aligned with ASTM E2500, ICH Q9, and ISPE Baseline Guide Vol. 5 principles.

Inspection Readiness & Regulatory Response

Pre-inspection documentation gap assessments against FDA Warning Letter observations, EMA inspection findings, and CDSCO Schedule M requirements. Includes remediation planning, SOP correction, deviation closure, CAPA documentation, and mock audit support to ensure facilities are perpetually inspection-ready — not just compliant on paper.

Contact IKE

Start Your GxP Engineering Consultation

Whether you're commissioning a new facility, preparing for an FDA or EMA inspection, executing a CSV lifecycle for DeltaV or PCS7, or closing out qualification punch points — IKE brings the regulatory knowledge, documentation discipline, and hands-on execution capability to move your project forward.

Speak With a GxP Engineering Specialist

Connect with IKE for CQV execution, GMP facility qualification, CSV validation, automation support, inspection readiness, and lifecycle engineering assistance.

Phone

97867 42263

Website

infinitykatalyst.com

Location

Dharmapuri, India

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