White Papers
White papers here are written for quality managers, regulatory leads, and owners who have to plan a transition — not just pass the next audit. They sit between the short insights and a paid engagement.
The quality systems and regulatory compliance guide
The first title is free to read: The Complete Guide to Quality Systems and Regulatory Compliance. It covers eight regulated sectors with implementation timelines, cost ranges, and common findings:
- Medical devices — FDA QMSR (effective February 2, 2026) and ISO 13485:2016
- Pharmaceuticals — 21 CFR 210/211, data integrity, ALCOA+
- Biotechnology — BLA / 351(k) quality systems
- Aerospace — AS9100D and CMMC adjacency
- Advanced manufacturing — ISO 9001 and digital QMS
- Dietary supplements — 21 CFR 111 identity testing
- Cosmetics and personal care — MoCRA and ISO 22716
- Contract laboratories — ISO/IEC 17025
Sector pages sit next to it so a commercial query can land on the industry, then read the long form:
How this differs from insights and case studies
Insights are field notes — visual management, root cause, ethics, leading versus managing. Case studies are completed engagements with a named outcome (QMS remediation, CAPA rebuild, lab turnaround, LIMS). Use the guide when you need the regulatory map; use a case study when you need proof the map was walked.
Further white papers are in preparation. If there is a topic you would find useful — a QMSR transition plan, a MoCRA GMP gap list, an ISO 17025 method-validation pack — tell us what you are working on.
The work is led by Phillip Marzouk (ASQ CMQ/OE, CQA, CSSGB, ISO 13485 Lead Auditor). Open consultant roles are listed separately.