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What we do

End-to-end support for physical, digital, and quality systems.

Each engagement is built around the evidence required to show that facilities, equipment, processes, and systems are fit for intended use and remain controlled.

FLAGSHIP ENGAGEMENT

GMP Readiness Assessment

Find the gaps before an inspector does. A focused four-week assessment establishes the baseline, identifies weak evidence and unclear ownership, and converts findings into a sequenced remediation plan. It’s the Assess step of our Assess → Build path — follow it with QMS Writing when you want the system built, not just mapped.

How it runs: week 1 — documentation review (remote); week 2 — on-site walkthrough and interviews; week 3 — gap analysis; week 4 — readout with your leadership.

Discovery and scope map — products, processes, systems, stakeholders
Current-state evidence review across procedures, records, and files
Prioritized gap register by risk, impact, owner, and action
Readout and remediation roadmap with immediate containment

Stainless-steel process equipment with gauges and valves

CQV

Commissioning, Qualification & Validation

Structured lifecycle support for facilities, utilities, manufacturing equipment, laboratory equipment, and controlled processes.

Validation master planning and strategy
User requirements and design review
Installation, operational, and performance qualification
Protocol development, execution support, and discrepancy resolution
Calibration and preventive-maintenance alignment
Requalification and continued verification planning

Quality-control laboratory workstation with data dashboards

CSV

Computer System Validation

Risk-based validation for software that creates, processes, reports, or preserves quality-critical and regulated information.

System inventory and GxP impact assessment
User requirements and configuration specifications
Risk assessment and requirements traceability
Test planning, scripted testing, and evidence review
Access, audit trail, backup, and recovery controls
Change control, periodic review, and retirement planning

QUALITY SYSTEMS

Documentation & remediation

Targeted support to close findings, strengthen the quality system, and make operating evidence easier to produce and defend.

SOP and work-instruction development
Document-control structure and templates
Batch-record design and review workflows
Training matrix and qualification records
Deviation, investigation, and CAPA support
Change-control and impact-assessment tools
Data-integrity and record-review practices
Mock inspection and response preparation

DEEP DIVES

Service pages, in detail.

Each practice area below has its own page: the method, the failure patterns we see, and answers to the questions buyers ask before they call.

GMP Readiness Assessment

Our flagship four-week engagement: gap register, remediation roadmap, and starter templates. Fixed fee, scoped in your SOW.

CQV — Commissioning, Qualification & Validation

The V-model lifecycle for facilities, utilities, and equipment, from URS through requalification.

CSV — Computer System Validation

Risk-based GAMP 5 validation for LIMS, spreadsheets, ERP, and lab systems, with 21 CFR Part 11 controls.

Equipment Qualification

IQ/OQ/PQ protocol development and execution for processing, packaging, utility, and laboratory equipment.

Cleaning Validation

Justified residue limits, worst-case soils, and allergen changeover evidence for shared lines and co-packers.

Data Integrity & 21 CFR Part 11

ALCOA+ assessments, audit-trail controls, and remediation for paper, hybrid, and electronic records.

Validation Remediation

Structured recovery after FDA 483s, warning letters, and failed audits — triage, planning, re-validation, re-readiness.

GDP & Cold Chain Qualification

Thermal mapping, shipping lane qualification, and excursion defense for temperature-sensitive products — road, air, and water.

Periodic Review & Requalification

Risk-based review schedules and change-linked requalification that keep the validated state alive.

Quality Policy

Our working principles in writing — evidence first, risk-based effort, honest scoping, and what we refuse to do.

QMS Writing & Implementation

The Build step of our Assess → Build path: done-for-you quality management systems — quality manual, SOP library, CAPA, change control — written and implemented with your team.

Confidentiality

How we protect client information: NDAs first, need-to-know access, no names in marketing without permission.

QUESTIONS

Answers before you ask.

Straight answers on scope, industries, and how engagements run.

What does the 4-week GMP Readiness Assessment cover?

Week 1 is remote document review; week 2 is an on-site walkthrough and interviews; week 3 is gap analysis; week 4 is a leadership readout. You receive a prioritized gap register ranked by risk, impact, and owner, plus a sequenced remediation roadmap with immediate containment actions.

Do you work with companies outside cannabis?

Yes. Cannabis is our home base and spearhead, and the same evidence discipline serves food & beverage, dietary supplements, cosmetics, and pet food manufacturers. Our food & beverage, dietary supplement, cosmetics, and pet food programs map our method to 21 CFR Part 117, 21 CFR Part 111, MoCRA, and 21 CFR Part 507 respectively.

What is the difference between CQV and CSV?

CQV — commissioning, qualification, and validation — covers the physical layer: facilities, utilities, equipment, and controlled processes, proven through IQ/OQ/PQ. CSV — computer system validation — covers the digital layer: the software that creates or preserves quality-critical records, validated through requirements, risk-based testing, and traceability.

Can you help after we receive an FDA 483 or warning letter?

Yes. Warning-letter and 483 response is one of the highest-value uses of a readiness assessment: we trace each observation to its root cause, build the evidence the response commits to, and sequence corrective actions so the follow-up inspection finds closures, not repeats.

Do you replace our QA team?

No. We are a specialist surge team, not a replacement hire. Most engagements run alongside your existing QA staff — we bring the validation protocols, gap analysis, and remediation sequencing; your team keeps ownership of the operation.

How fast can we start, and do you work on-site?

Fit calls are typically scheduled within a week, and assessments can begin as soon as scope is agreed. Delivery is hybrid: remote document review plus two to three days on-site for the walkthrough, anywhere in the US.

Ask us directly

Not sure where to start?

Take the 3-minute self-check — or book a free GMP readiness call: we'll walk through your top 3 risks and give you an honest fit assessment. Confidential, zero pressure.

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