Audit-Ready QMS Documentation, Built by Industry Veterans
qmsdoc.com is operated by eCompliance Ltd., a Tokyo-based regulatory consulting firm with over 17 years of experience supporting pharmaceutical, medical device, and regenerative medicine companies through FDA, PMDA, EMA, and PIC/S inspections.
We do one thing very well: we write QMS documentation that holds up under inspection. The same procedures, policies, and forms our consultants use on client engagements are sold here as off-the-shelf templates, in editable Microsoft Word format, ready to be tailored to your operations.
What We Offer
We provide downloadable QMS document templates aligned with the major quality and computer system regulations affecting medical device and pharmaceutical manufacturers:
- FDA Quality System Regulation (21 CFR Part 820)
- FDA Quality Management System Regulation (QMSR, effective February 2026)
- Medical Device Reporting (21 CFR Part 803)
- GMP for pharmaceuticals (Japan GMP Ministerial Ordinance, PIC/S GMP)
- Computer System Validation (CSV) and 21 CFR Part 11 / ER/ES compliance
- Data Integrity controls aligned with FDA, MHRA, and PIC/S guidance
Each template package includes the relevant procedures, work instructions, and forms, with clear cross-references to the applicable regulatory clauses. You modify them to match your processes, validate them, and put them straight into your QMS.
Why Companies Choose Us
Built by practitioners, not lawyers. Every template starts as something we used on a real client engagement — to prepare a medical device manufacturer for an FDA inspection, to remediate observations after a Form 483, or to bridge a gap during a PMDA audit. We refine the language until it survives in the field, then make it available here.
Save weeks, not days. A full QMS documentation set typically takes a small team months to draft from scratch. Our templates compress the heavy lifting into editable starting points, so your team focuses on adapting language to your processes — not staring at a blank page.
Designed for global submissions. Our templates use harmonized language wherever possible, so a single procedure can serve as evidence in multiple jurisdictions. Where regulations diverge (for example, FDA QSR vs. FDA QMSR vs. ISO 13485), we provide guidance on the differences in the document itself.
Updated as regulations evolve. Regulatory expectations move. We track FDA Federal Register notices, PIC/S guidance updates, and major ICH/ISO revisions, and we keep our templates aligned with the latest published expectations.
Leadership and Experience
Koichi Murayama — Representative Director, eCompliance Ltd.
Mr. Murayama has more than 30 years of experience in the pharmaceutical and medical device industry, with deep specialization in:
- FDA inspections and Form 483 / Warning Letter remediation
- 21 CFR Part 820 (QSR) and the new FDA QMSR
- Computer System Validation (CSV / CSA) and 21 CFR Part 11
- Data Integrity programs aligned with FDA, MHRA, and PIC/S guidance
- PIC/S GMP and Japan GMP Ministerial Ordinance
- ISO 13485 and IEC 62304 (medical device software)
Before founding eCompliance Ltd. in 2008, Mr. Murayama held quality and regulatory roles at major pharmaceutical and IT firms in Japan and abroad. He has authored numerous Japanese-language books on FDA compliance, computer system validation, and quality management, and is a frequent speaker at industry seminars on FDA QMSR transition, CSA, and AI compliance.
Our Other Activities
eCompliance Ltd. is more than a template store. We also provide:
- Regulatory consulting for FDA inspections, QMS construction, and remediation
- CSV / CSA / Part 11 advisory for IT and laboratory systems
- Industry seminars and on-demand video training for QA, RA, and IT teams
- Books and publications on regulatory compliance topics
Customers who purchase our templates can engage us for additional implementation support, gap assessments, mock audits, or staff training on request.
Where We Are
eCompliance Ltd.
Town Heights Ginza 406
7-15-8 Ginza, Chuo-ku
Tokyo 104-0061, Japan
Telephone: +81-50-3733-8134
Fax: +81-3-6745-8626
Email: support@eCompliance.co.jp
We work with clients across North America, Europe, Asia, and Oceania, and we typically respond to email inquiries within one Tokyo business day.
Get in Touch
If you have questions about which template package fits your project, need a custom scope, or want to discuss enterprise licensing, please email support@eCompliance.co.jp. We’re glad to help you choose the right starting point — or, if our templates are not the right fit for your situation, we’ll tell you that too.