Site in Development This site and all its features will be fully operational in the first week of July 2026. For any questions or services, contact Melvyn directly or set up a meeting → or email Melvyn
2Dyles Services — 2DS

ICH GCP E6(R3) demands risk-based auditing. The preparation time does not.

The regulation requires you to know the risk profile of every engagement before you walk in. One to two days of preparation makes that impossible. Engine v1 changes that -- processing the documentation, surfacing the risk signals, and letting you audit what actually matters.

Holistic Health • Live
Remanence
A guided narrative process. Your story, mapped across the patterns that have shaped your life.
GxP AI • Core Validated
GxP AI Auditing Engine v1
E6(R3) mandates risk-based auditing. Risk-based auditing requires pre-audit intelligence you cannot generate manually in the time available. Engine v1 does it for you.
Innovation Pipeline
More Solutions in Development
Several innovative solutions have been developed and are currently under review. Details to follow as they are validated and released.
Remanence

Your Narrative, Mapped.

A quiet space for people who are ready to understand, not just manage.

In physics, remanence is the quiet charge that remains in a material long after the external force is gone. In human terms, it is the original blueprint that survives every pressure, expectation, and hardship you have carried.

↓ Continue reading

How it works

You share your story in your own words, at your own pace. From there, your narrative is mapped across three quiet layers: how your daily reality and physical rhythms carry the weight of your days; how family, culture, and early systems shaped your instincts and boundaries; and what your unspoken patterns are trying to protect you from, and what they are pointing toward.

Using a structured, AI-assisted mapping process, a clear, grounded dossier of your patterns is reflected back to you. This is not a report to read once and file away. It is a living mirror. Most clients need about four guided follow-up conversations to fully absorb what comes up and begin shifting in a sustainable way. More sessions can always be added at your pace.

Your Daily Reality
Where you live and work. How your body feels on a regular day. Sleep, movement, what drains you, what restores you. Any physical rhythms or tensions that keep showing up.
Your Early Foundation
Who raised you, what was spoken (or never spoken) at home, early shifts or shocks that changed your path, and how you navigate closeness, groups, or solitude now.
Your Inner Rhythm
Habits or instincts that do not quite make logical sense but feel deeply yours. Times you lose yourself in thought or creation followed by sudden fatigue. What practices, if any, help you feel steady or anchored.
A few things to know before you begin Remanence is not a substitute for medical or psychological care, and it does not offer diagnoses or quick fixes. It is designed for people who are willing to sit with discomfort, do the internal work, and understand that real shifts take time.

Your words belong to you. All raw notes, voice recordings, and texts are permanently deleted once your insight map is created unless you request otherwise. You remain the sole custodian of your story.

The initial intake and report are offered on a donation basis. Guided 1:1 sessions and personalised restorative advisories are at a clear, flat rate. There is no pressure to move faster than your being allows.

Begin your intake

Share as little as you are comfortable with. You can always add more later. You can type, speak, or upload a document. There is no right or wrong way to begin.

First, confirm your email
A confirmation link will be sent to your email before your intake opens. This keeps your space private and protects the integrity of the process.
A confirmation link has been sent. Please check your inbox and click the link to begin your intake.
For security purposes, a record of access attempts is retained. Your narrative content is deleted after your report is generated. See our Privacy Policy for full details.
Before we begin
A name and an email address, nothing more.
Your name can be a first name, an initial, or anything you choose. Your email is only used to send your report.
Layer one — Your Daily Reality
How does your body feel on a regular day?
Where you live and work. Sleep, movement, what drains you, what restores you. Any physical rhythms or tensions that keep showing up. Share in whatever way feels natural.
Upload a document — choose file
Layer two — Your Early Foundation
What shaped the way you navigate the world?
Who raised you, what was spoken (or never spoken) at home, early shifts or shocks that changed your path, and how you navigate closeness, groups, or solitude now.
Upload a document — choose file
Layer three — Your Inner Rhythm
What feels deeply yours, even if it defies logic?
Habits or instincts that do not quite make logical sense but feel deeply yours. Times you lose yourself in thought or creation followed by sudden fatigue. What practices, if any, help you feel steady or anchored.
Upload a document — choose file
Your Pattern Map
Generating your map...
This map was prepared for you on a donation basis

Give what feels right. There is no minimum. If this map has offered you something of value, a contribution helps sustain this work.

€10
€25
€50
Other
You will confirm your amount and pay securely on Stripe's own page.
Your report will be emailed to you after your intake and payment are matched.

Book a session

Guided 1:1 sessions, follow-ups, and personalised restorative advisories go deeper than the initial map. To book, upload your completed report so that the session can be prepared specifically for you.

How sessions work Sessions are conducted via video or voice call. Your report is reviewed in advance. The session focuses on what the map revealed and where your patterns are pointing. Most clients need four to eight sessions across two to three months for sustainable shifts.
Upload your Remanence report — choose file
Your session request has been received. Melvyn will be in touch within 48 hours to confirm a time and share payment details.
Knowledge

Learning

Courses built from practice, not theory. GxP auditing, AI governance, ethical leadership, and AI literacy for every age.

UN Commission Ethical AI in Education — Nominee 2025 2DS was nominated for the UN Commission Ethical AI in Education Award 2025, recognising the contribution of the 2DS learning programmes to ethical AI literacy across professional and public audiences.
What We Build

Innovations

From AI audit intelligence for GxP-regulated organisations to holistic health technology and EU regulatory policy. Tools built from practice, not theory.

What changed and why this exists

ICH GCP E6(R3) introduced a legal obligation that most audit programmes cannot currently meet: genuine risk-based auditing requires knowing the risk profile of an engagement before it begins. That means processing and synthesising volumes of documentation in a preparation window that has not changed in 30 years.

Melvyn Rapprecht has been a GxP auditor for over 30 years. Engine v1 was built to solve a problem he encountered directly, repeatedly, and saw no credible solution to -- until AI made it possible to process what a human auditor cannot process alone in the time available.

Platform Transition Notice

All OpenAI-based Auditing GPTs will be retired by the end of this week, as the validated QA Engine system comes fully online. For licensing enquiries, contact Melvyn Rapprecht: mrapprecht@2dyles-services.com.

Final Validation Stage
QA Engine v1 Platform
The enterprise management layer that sits around Engine v1. Designed for organisations running multiple audit engagements or deploying the engine across teams. Provides project workspace and engagement management, CRM import to initialise projects from existing data, anonymisation of uploaded documents before any AI processing, a dedicated security layer with hard-lock enforcement, and a complete chain-linked audit trail satisfying ALCOA+ and EU Data Act requirements. Multi-tenant from day one -- each organisation's data is completely isolated. Hosted in Europe with EU data residency. Under final validation.
Under Final Validation
Next Generation — Conceptualised
Digital Governance Platform
The v2 evolution beyond Engine v1. Extends from individual audit engagements to portfolio-level quality governance. Planned capabilities include CAPA efficiency assessment across the engagement portfolio, cross-portfolio finding trend intelligence, and a self-validating agent architecture with no equivalent in the current market. The accumulated dataset across production engagements becomes a standalone commercial asset -- the first empirically grounded cross-portfolio GxP audit intelligence resource in the industry. Several innovative solutions have been developed and are currently under review. As soon as they have been developed, validated, or endorsed by regulatory authorities, they will be released.
Conceptualised — Under Review
Holistic Health
Remanence Engine
A proprietary interpretive framework mapping biographical patterns, systemic pressures, and embodied responses. Active development. Licensing structure in progress. Further details to follow.
v0.1.8 — Active Development
Innovation Pipeline
Additional Solutions in Development
Several innovative solutions have been developed and are currently under review. As soon as they have been developed, validated, or endorsed by regulatory authorities, they will be released. Watch this space.
Under Review
Apps — Coming Soon
More Apps on the Way
Several apps are scheduled to be released this year. Watch this space.
Coming Soon
EU AI Act Compliance
EU AI Act Regulatory Engagement
2DS is actively engaged with European regulatory authorities under the EU AI Act framework. The platform is being developed with a structured regulatory compliance posture, and dialogue with relevant authorities is ongoing.
Regulatory Engagement Active
Publications

Articles & Publications

Research, commentary, and practical guides across GxP quality, AI governance, regulatory policy, and education. Articles span from 2022 to 2026.

GxP Auditing & AI
Forthcoming — RQA, July 2026
From Transcription to Pipeline: Reframing Data Integrity Risk in Clinical Trials
A regulatory affairs white paper arguing that source data verification was built for a world of manual transcription, while modern eClinical data moves through automated system handoffs instead. Drawing on FDA and EMA inspection data alongside financial-audit methodology (ISA), it proposes shifting GxP audit and monitoring effort toward systems-based review -- metadata integrity, audit trail continuity, and transfer security -- and identifies an unaddressed gap in ICH E6(R3) around evidencing data integrity through ownership transfer. To be published in RQA next week.
White Paper
July 2025
Why AI Deployments in Pharma Are Failing
The promise of AI in pharma is real. The ROI is not yet. An honest analysis of why validation costs, fragmented upskilling, and governance gaps are blocking production deployment, and what a shared modular infrastructure model could solve.
Opinion
May 2025
ROI Analysis: AI GPT Audit Model vs Conventional Audits
Quantitative pilot study across three audit engagements. The AI-assisted model cut 178.5 auditor hours (56%), saved over €30,000 in labour, and recovered its development cost in under one month. Data from 2DS audit logs and signed project proposals.
Data
August 2025
AI Predictive Trajectory for Life Sciences 2025–2035
A CEO brief on how AI will reshape pharmaceutical R&D, regulatory engagement, and operating models over the next decade. Four strategic imperatives for leadership teams navigating the transition from pilot to production.
Strategy
July 2024
Comprehensive Assessment Framework for AI Tools
A proposal for how regulated industries should audit and assess AI performance. Covers LLM-specific risks including prompt injection, training data poisoning, model drift, and governance gaps absent from existing regulatory frameworks.
Framework
May 2024
Navigating the Future of Quality in Clinical R&D
An interview exploring how AI, blockchain, and automation are reshaping the quality function in clinical research, and what the quality professional of the future will need to look like.
Interview
February 2023
Chats with ChatGPT: AI Impact on QA and CSV Audit
An early exploration of AI capabilities and limitations for GxP quality assurance, written when ChatGPT had just been released. Documents the first structured dialogue between a GxP auditor and a large language model on audit and compliance topics.
Historical
June 2022
The Future of Audits
A longitudinal analysis of how GxP auditing has evolved over 30 years and why the process has not kept pace with the complexity of modern clinical trials. The argument for a dynamic, AI-assisted audit model. Written from the independent consultant perspective.
Analysis
GxP Regulatory
January 2025
ICH GCP E6(R3) Examined
A practical breakdown of all 11 ICH GCP E6(R3) principles and the key changes from R2. Covers data governance, risk management, system validation, access management, monitoring evolution, and the new essential document structure.
Regulatory
November 2024
Impact Comparison: ICH GCP E6(R2) vs E6(R3)
A structured comparison of nine key differences between R2 and R3, with implications for quality management, technology integration, ethical oversight, and the shift toward quality by design.
Regulatory
December 2024
Trend Analysis: FDA & EMA GCP Findings 2017–2023
Data-driven analysis of weighted inspection findings across protocol compliance, documentation, IMP handling, informed consent, and monitoring. Identifies diverging trends between FDA and EMA enforcement patterns.
Data
August 2023
Challenges in Implementing EU Regulation 910/2014 (eIDAS)
Comparative analysis of eIDAS against 21 CFR Part 11 and Japanese ERES. Examines why the EU regulation has seen lower integration despite its ambition, and the cultural, legal, and technical factors involved.
Regulatory
October 2023
History of GCP: From Ancient Pharmacology to Modern Inspection
A historical sweep from ancient pharmacopeia through the first clinical trials, the thalidomide crisis, the emergence of GCP in the 1990s, and the regulatory milestones that shaped the modern audit function.
History
Education & Learning
March 2025
How to Achieve Personalized Adaptive Learning
A practical guide to implementing adaptive learning pathways on platforms like Thinkific, including modular content design, automation tools, and AI coach integration. Based on the 2DS Knowledge Hub implementation.
Framework
November 2024
Is Education Keeping Up with the Future?
A provocation. Why the one-size-fits-all education model is failing students, why degrees are diverging from the skills employers need, and why personalized technology-enabled learning is no longer optional. Written in context of the UN Ethical AI in Education nomination 2025.
Opinion
EU AI Policy
June 2026
A Proportionate Pathway for Healthcare AI Regulation in the EU
A policy proposal exploring a verified risk-fingerprinting model and portable risk profiles to make proportionate AI compliance achievable at scale for innovators and small enterprises. Full details to follow as engagement with regulatory authorities progresses.
Policy
All articles are available on request. For speaking or collaboration enquiries related to any of these topics:
mrapprecht@2dyles-services.com | Book a conversation →
Independent Research

Personal Research & Interests

Research conducted independently, outside the GxP and AI governance domains. These projects sit at the intersection of consciousness science, information theory, ancient knowledge systems, and cosmology.

ORCID: 0009-0001-1566-3603

Consciousness Science • September 2025

The Multidimensional Consciousness Assessment Framework (MCAF)

A Unified Approach to Quantifying Awareness Across Systems
View on bioRxiv →

MCAF proposes a quantifiable framework for evaluating consciousness across biological, artificial, and hybrid systems. Grounded in information theory, dynamical systems, network science, and neuroscience, it defines consciousness as a graded property emerging when informational integration exceeds inflection points and oscillatory vibrational states align. The framework yields falsifiable predictions and a clear path for parameter estimation across human, animal, and artificial systems.

Published on bioRxiv: BIORXIV/2025/678474 • Four supplementary papers accompany the main manuscript (S1: Extended Rigor; S2: IQRIFT Conceptual Precursor; S3: Anomalous Phenomena; S4: Nested and Collective Consciousness) • Affiliations: 2Dyles Services; Visiting Lecturer, University of Amsterdam

Consciousness Theory • November 2024

IQRIFT: The Quantum Bridge

Exploring Consciousness, Information, and the Essence of the Universe

The conceptual and philosophical precursor to MCAF. The Integrated Quantum Relational Information Field Theory (IQRIFT) proposes that consciousness is the interpretive field through which information as a substrate becomes lived experience. Intent, fields, and time are treated as co-equal elements of reality alongside matter and energy. IQRIFT is explicitly exploratory and is retained as a hypothesis-generating framework rather than an empirically validated model.

Working paper, 2024. Available on request.

Archaeology • Minoan Studies • 2025

The Phaistos Disc as Mnemonic Artifact

Governance, Protection, and Seasonal Prompt and Activities in Minoan Crete
View on Academia.edu →

This paper advances a third interpretive framework for the Phaistos Disc, beyond the two dominant positions of script and art. The Disc is reframed as a mnemonic aide-memoire: a visualised cycle designed to cue oral transmission of agricultural, ritual, protective, and maritime governance responsibilities in Minoan Crete. Statistical analysis of oblique stroke placement and thematic clustering across both sides supports the dual governance hypothesis. Comparative parallels include the Inca quipu, Aboriginal songlines, Native American winter counts, and medieval European memory wheels. Accompanied by an analytical supplement with full dataset, Python-based analysis, and results.

Published on Academia.edu. Peer community reviewed. Submitted for journal review. AI-assisted analysis acknowledged (GPT-5, DeepSeek, Manus.ai); all interpretive decisions remain the responsibility of the author.

These works are independent of 2DS commercial activities. They reflect a sustained personal interest in the nature of consciousness, information systems, knowledge transmission, and the deeper questions that sit at the boundary of science and philosophy. Collaboration and peer dialogue on any of these topics is welcome.

mrapprecht@2dyles-services.com  •  ORCID: 0009-0001-1566-3603

Your Experience

Feedback

All feedback is read personally. It shapes how this work develops.

Founder

Melvyn Rapprecht

Some people build careers. Melvyn Rapprecht has been building something harder to name -- a body of work that keeps asking what systems are actually for, and whether the people inside them are being served or consumed by them.

He trained in medicine before moving into pharmaceutical quality assurance, a field he has worked in for over thirty years across every major continent. More than three hundred audits. Every GxP domain. Investigator sites, CROs, laboratories, QMS programmes, computerised systems, pharmacovigilance, and increasingly, artificial intelligence. He held senior quality leadership roles within global pharmaceutical organisations, including years at Roche where he led audit functions spanning more than eighty countries, before establishing his own practice.

In 2003 he co-founded Adamas Consulting -- a name chosen for what it means in its oldest sense: steadfast, unyielding, of the hardest substance. A quality assurance firm built on the premise that genuine compliance is not a performance for inspectors but a commitment to the people at the end of the process.

What connects his work across these domains is not versatility in the conventional sense. It is a specific habit of mind: when a problem resists solution from within its own field, he looks for the answer in another. That instinct has produced novel frameworks, proprietary architectures, and approaches that did not previously exist in any of the disciplines they draw from.

2Dyles Services takes its name from Freddie Dyles, whose approach to leadership, mentorship, and community engagement shaped Melvyn's own. The name is a tribute as much as a brand -- a way of carrying forward an ethos of service that has nothing to do with commercial positioning.

He founded 2Dyles Services to bring that ethos to the intersection of GxP practice and artificial intelligence. The GxP AI Auditing Engine addresses a structural problem that ICH GCP E6(R3) made impossible to ignore: risk-based auditing requires pre-audit intelligence that the conventional preparation window cannot produce. The Engine processes what an auditor cannot process alone in the time available, and places the human auditor where their judgement is actually needed.

His work in education reflects a parallel conviction: that learning designed for an average learner serves no actual learner well. The sixteen courses on the 2DS Knowledge Hub integrate adaptive AI coaching, ranging from advanced GxP auditing to ethical AI literacy for parents, students, the elderly, and educators. A nomination for the UN Commission Ethical AI in Education Award in 2025 recognised the reach of that work across audiences well outside the pharmaceutical sector.

Remanence represents a different kind of crossroads. Thirty years of working inside complex systems -- watching how data gets missed, how risk gets managed on paper rather than in practice, how the person at the end of the process can disappear inside the machinery -- has left him with a question that audit frameworks cannot answer. What does a person actually need when the system has not served them? Remanence is not a diagnostic tool. It is a structured, guided process for understanding the patterns that have shaped a life -- the biographical, the somatic, the relational. The premise is that there is more to a human situation than the empirical scientific framework typically acknowledges, and that understanding this wider picture is not mysticism but a different, and necessary, form of rigour.

His research interests extend well beyond professional boundaries. He has published on the multidimensional nature of consciousness -- proposing a quantifiable framework that bridges information theory, neuroscience, and complex systems science -- and on the Phaistos Disc, which he argues is not an undeciphered script but a mnemonic governance device encoding Minoan agricultural and maritime cycles. These are not peripheral interests. They reflect the same pattern of thinking: looking at how systems carry knowledge, how that knowledge is validated, and what happens when the structure breaks down.

He is a Visiting Lecturer at the University of Amsterdam. His work has been published on bioRxiv. He holds ORCID 0009-0001-1566-3603.

A note on what this biography does not say. It does not describe a smooth ascent. It does not mention that some of the most significant work produced under the 2DS name was conceived during a period of sustained personal difficulty -- because that is not the kind of detail a professional biography typically carries. But it is worth knowing, for anyone who works with him, that the output did not stop. Whether that represents resilience or compulsion is a question he is still working out.

Recognition
UN Commission Ethical AI in Education — Nominee 2025
Co-Founded
Adamas Consulting — Pharmaceutical Quality Assurance
Expertise
International GCP • CSV • AI Auditing • AI Governance • Holistic Health • Innovator
Based
Europe
Policy
Active engagement with EU regulatory authorities on healthcare AI policy, 2026
Get in Touch

Contact

For Remanence enquiries, Engine v1 commercial discussions, innovation and policy collaboration, or anything else.

Location: Europe
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Work Together

Book an Appointment

Available for training delivery, guest lectures, consultancy engagements, advisory roles, and general enquiries about 2DS services.

Training
Course Delivery
On-site or virtual delivery of any 2DS course for your organisation. Bespoke packages available.
Speaking
Guest Lectures
GxP AI auditing, ethical AI governance, EU AI Act, holistic health technology, and regulatory innovation.
Consultancy
GxP & AI Advisory
GxP quality system design, CSV, AI audit strategy, EU AI Act compliance navigation, and regulatory engagement.
Advisory
Board & Strategic Advisory
Strategic advisory for organisations navigating AI adoption in regulated environments or holistic health technology.
Select a date and time
Your booking goes directly into the diary. You will receive a confirmation by email.

For Remanence sessions, please use the Remanence booking form above.

A personal note

None of this work existed in a vacuum. There were people who stood by me when I could not stand by myself -- who questioned, challenged, and stayed, even when I had lost faith in my own direction. I do not take that lightly. I will carry it always.

To my brothers and sister, and to the friends who proved themselves in the difficult years rather than the easy ones -- thank you. In hard times you learn who your people are. I know who mine are.

And to my mother, my little niece, and my nephew -- you were the anchor. That is not something I can adequately put into words, so I will simply say it plainly: thank you for being there.