21 CFR Part 11–aligned electronic workflows for pharmaceutical and medical device companies - delivered on platforms you already own, at a fraction of enterprise costs.
Before any configuration starts, we establish exactly where you stand, what's already validated, what needs work, and what the best path forward looks like.
A fixed-fee audit covering your SOPs and quality system (QMS), your Microsoft tenant readiness or Google Workspace capability, and your current validated systems landscape. Deliverable: a clear, prioritized remediation roadmap with a project scope defined.
Build the electronic workflow with your existing enterpise software. Every design decision is made with the current procedures in mind and user experience in the forefront.
Solution architecture traceability matrix to regulations, and a validation package your quality team can sign and file. You own the system and documents created - no dependency on Melnick GxP to maintain or update your system.
Every engagement is scoped to your actual situation - not a off the shelf solution that gets conformed. The focus is always on building something you can confidently defend at any audit and encourages use by your team due to usability.
End-to-end validation of custom built MES systems to GAMP 5 Category 4 standards. Includes URS, FS, configuration specifications, and a complete IQ/OQ/PQ protocol package.
Validated change request workflows built on Microsoft Power Apps or Google Workspace. Designed as authorization layers feeding your system of record - keeping validation scope proportionate and clean.
A fixed-fee, structured assessment of your current SOPs and quality system, Microsoft 365 tenant or Google Workspace configuration, and existing validated systems landscape. Delivers a prioritized roadmap and defined validation scope - the foundation for every downstream engagement.
Audit-finding remediation, legacy system re-validation, and ongoing CSV support for teams that need a qualified resource without the cost of a full-time hire. Flexible retainer or project-based engagements.
SOPCheck is an AI-assisted SOP review delivered as a consulting work product - every finding reviewed and signed off by a GMP professional before it reaches you. Findings span five categories (ALCOA+, clarity, document control, cross-references, and GMP red flags) with a deterministic health score your quality team can verify on resubmission.
SOP review is no one’s day job. Keeping procedures current pulls your team off the work they were hired to do. Start with a single document, or hand the whole function to us with a monthly retainer.
SOPCheck output is advisory input to your own document-control and quality processes. Your quality unit retains sole responsibility for document approval. No document, product, or service is certified by FDA or any regulator.
Melnick GxP Consulting was founded on a straightforward observation: most regulated companies are paying enterprise prices for validated systems that could be built on infrastructure they already own.
With direct, hands-on experience delivering GAMP 5-validated workflows at both pharmaceutical manufacturers and Class II medical device companies, Melnick GxP brings a practitioner's perspective and not a consultant's abstraction to every engagement.
The guiding principle: keep the flow you know. You don't need to redesign the process - you need a system that works with your team.
The design decisions made before the first screen is built determine whether validation is defensible or brittle. We get the architecture right first.
Not everything needs to be validated the same way. Correctly scoping GAMP categories keeps effort aligned with actual risk and keeps auditors satisfied.
Every validation package is written so your quality team can understand, maintain, and defend it without ongoing consultant involvement.
Building on platforms you already use means your IT team can support it, your quality team already has native access, and you're not locked into a vendor's roadmap.
Every engagement starts with a conversation. Tell us where you're at, and we'll give you upfront guidance on whether and how we can help.
No intake team, no account manager. When you reach out to Melnick GxP, you're speaking with the person who will actually do the work.
Prefer to book time directly? Schedule a free 30-minute introductory call - no pitch, just a candid conversation about your situation.
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