Commissioning and Qualification
Risk-based support for facilities, utilities, cleanrooms, equipment, and manufacturing support systems, including IQ, OQ, PQ, turnover, and startup activities.
Inspection-ready CQV, CSV, data integrity, gene therapy, and CAR-T support
Validation support for pharmaceutical, biologic, and advanced therapy operations.
ProtoCall LLC delivers focused commissioning, qualification, validation, technical documentation, and remediation support for pharmaceutical, biotechnology, medical device, gene therapy, and CAR-T manufacturing environments.
Services
Targeted validation services for regulated manufacturing environments.
ProtoCall supports project teams that need disciplined validation execution, defensible technical writing, and structured remediation support across the system lifecycle.
Computer System Validation
CSV support for laboratory, manufacturing, quality, and infrastructure systems, including protocol development, execution support, and documentation packages.
Data Integrity and Remediation
Assessment and remediation support for legacy documentation, compliance gaps, Part 11 control expectations, and quality-system-driven corrective actions.
GMP and Clean Utilities
Qualification and lifecycle support for GMP utilities and clean utility systems, including water, gas, distribution, and supporting infrastructure used in regulated operations.
CTUs and Warehouses
Validation and qualification support for controlled temperature units, storage areas, warehouse environments, mapping studies, and associated operational controls.
Computer Systems, QMS, and Change Management
Support for BMS, CMMS, quality systems, change control, procedural updates, and related compliance documentation requirements.
Gene Therapy and CAR-T Validation
Focused validation support for advanced therapy operations, including cleanroom readiness, equipment qualification, computerized systems, cold-chain controls, and documentation packages for cell and gene therapy manufacturing.
Advanced Therapy Readiness
Project support for biologics and advanced therapy clients preparing for scale-up, tech transfer, inspection readiness, remediation, or manufacturing start-up.
Chain-of-Identity and Data Controls
Support for validation and data-integrity controls where product identity, patient-specific materials, batch records, lab systems, CTUs, and electronic records must remain traceable and controlled.
28
Years of Experience
Validation and commissioning support in regulated manufacturing environments.
CQV
System Lifecycle Support
Commissioning, qualification, process support, remediation, and technical documentation.
CSV
Computerized Systems
Support for laboratory and manufacturing systems, data integrity, and validation deliverables.
GxP
Regulated Operations
Experience across pharmaceutical, biotechnology, and medical device environments.
Three-Year Growth Focus
Validation support for the strongest near-term growth areas: gene therapy, CAR-T, biologics, and advanced therapy operations.
Advanced therapy manufacturers face validation pressure from cleanroom readiness, small-batch or patient-specific manufacturing, computerized systems, cold-chain controls, chain-of-identity expectations, and rapid movement from clinical to commercial readiness. ProtoCall helps pharmaceutical customers close those practical gaps with focused CQV, CSV, technical documentation, and remediation support.
Cleanrooms
CTUs
Cold Storage
LIMS
BMS
CMMS
eBR
Environmental Monitoring
Autoclaves
Laboratory Systems
Compliance alignment: Support is aligned to GMP, 21 CFR Part 11, EU Annex 11, EU Annex 15, data-integrity expectations, and risk-based validation practices appropriate to the system, product, and intended use.
Gene Therapy and Viral Vector Facilities
Support for equipment, utilities, cleanrooms, computerized systems, documentation packages, and startup activities used in viral vector and gene therapy manufacturing environments.
CAR-T and Cell Therapy Operations
Validation support for controlled manufacturing spaces, patient-specific workflows, CTUs, cold storage, chain-of-identity controls, batch record systems, and readiness packages.
Biologics and Advanced Modality Scale-Up
Project support for organizations moving from development or clinical operations toward larger-scale, more inspection-ready GMP manufacturing.
Customer Benefit: Faster Readiness
Focused validation planning and execution support helps clients reduce documentation backlog, improve review quality, and move systems toward operational readiness.
Customer Benefit: Defensible Evidence
Protocols, reports, deviations, traceability, and supporting SOPs are structured to help Quality, Engineering, Manufacturing, and Operations defend the validation package.
Customer Benefit: Targeted Remediation
Gap assessments and remediation plans help clients prioritize the controls that matter most for GMP risk, data integrity, cold-chain control, and inspection readiness.
Advanced Therapy Project Support
Focused validation support for high-growth pharmaceutical operations.
From gene therapy and CAR-T startup support to remediation, computerized systems, cold-chain controls, and documentation recovery, ProtoCall is positioned for practical project delivery.
About the Principal
John-Patrick Coane
John-Patrick Coane is a senior validation and commissioning professional with 28 years of experience supporting pharmaceutical, biotechnology, and medical device operations in regulated manufacturing environments. His background includes commissioning, qualification, process validation, cleaning validation, computer system validation, technical investigations, SOP generation, remediation, gap assessment, and project support for laboratory, utility, facility, and manufacturing systems.
His experience spans aseptic processing, autoclaves, CIP and SIP systems, cleanrooms, analytical instrumentation, technology transfer, facility startup, and cross-functional execution with Quality, Manufacturing, Engineering, Operations, and client stakeholders. He holds Master of Science and Bachelor of Science degrees in Chemical Engineering from the University of South Florida.
Representative Qualifications
Areas of practical support
- Commissioning and qualification of facilities, utilities, process equipment, and manufacturing support systems.
- Cleaning validation, process validation, and technical documentation for regulated operations.
- Computer system validation activities for laboratory and manufacturing environments.
- Gap assessment, remediation planning, SOP development, and deviation or investigation support.
- Experience with autoclaves, cleanrooms, CIP/SIP systems, analytical equipment, biologics environments, and facility startup activities.
How ProtoCall Works
A practical process built for project execution.
Engagements are structured to move efficiently from scope definition through deliverable development, execution support, and validation closeout.
01
Assess
Review current-state documentation, system boundaries, timelines, and compliance drivers.
02
Plan
Define scope, deliverables, validation strategy, and practical execution sequencing.
03
Execute
Develop and support protocols, testing, evidence collection, deviations, and technical documentation.
04
Close
Finalize reports, turnover materials, remediation actions, and closeout-ready documentation packages.
Contact
Start with a focused conversation.
Contact ProtoCall LLC to discuss validation scope, gene therapy or CAR-T project support, remediation, startup planning, or technical documentation needs for regulated operations.
Phone
1-856-912-5495
Mailing Address
ProtoCall LLC.
Attn: John-Patrick Coane
2001 83rd Ave N, Lot #1283
Saint Petersburg, FL 33702
Best Practice
Include your company, project type, and requested timeline in your initial message.
Direct Contact
Reach ProtoCall directly.
For project inquiries, remediation support, or validation planning, contact ProtoCall LLC by email or phone.
Ideal for early-stage project scoping and validation planning discussions.
Include your company, project type, target timeline, and primary system or area of concern.
ProtoCall supports clients across North America with focused project-based engagement.