Overview
This comprehensive Integrated Management System — the most extensive in the catalog — serves non-clinical research and development laboratories conducting safety and regulatory studies. It integrates OECD GLP Principles, FDA 21 CFR Part 58, ISO/IEC 17025, ISO 15189, and ISO 9001 into a single, rigorously controlled framework built for regulatory study integrity. The documentation governs the complete GLP study lifecycle: study plans and protocols, Study Director and personnel responsibilities, test-item characterization and handling, standard operating procedures, raw-data capture, archiving, and final report certification. A dedicated Quality Assurance program, independent of study conduct, provides the inspections and audits GLP demands. A master Quality Manual and compliance scheme map every principle to a control, while an exceptionally deep procedure and form library enforces traceable, reconstructable data and full chain-of-custody. Checklists mirror regulatory inspection modules, and training modules build and document the competencies of Study Directors, technicians, and QA staff. The ISO/IEC 17025 and 15189 layers add technical-competence rigor for analytical and bioanalytical work. This kit is ideal for CROs, toxicology and bioanalytical labs, and R&D facilities preparing for GLP monitoring-authority inspection or study-sponsor audits. Fully editable, it adapts to your study types, test systems, and facilities. By systematizing study conduct, data integrity, and independent QA, it protects study validity, withstands regulatory scrutiny, and accelerates the acceptance of your data in submissions — turning GLP compliance into a durable competitive and scientific advantage.
Included: 88 ready-to-use, fully editable documents (manual, procedures, forms, records, checklists, guidance and training material).
License: single-organization license; delivered electronically as a ZIP archive.
From purchase to audit-ready
Buy & download instantly
Pay securely by card. Your ZIP download link appears immediately on the confirmation page and in your email.
Edit & brand as your own
Open the native Word & Excel files, add your logo and details, and adapt everything to your organisation.
Implement & get audit-ready
Roll out the manuals, procedures, forms and checklists to build a working, certification-ready system.
Frequently asked questions
What exactly do I receive?
A downloadable ZIP containing the full set of ready-to-use documents for this toolkit — manuals, procedures, forms, records, checklists, guidance and training material, all in editable Word and Excel format. The exact document count is shown at the top of this page.
Are the documents really editable?
Yes. Every file is native Microsoft Word or Excel — no locked PDFs. Add your logo, change wording, and tailor the content to your organisation. The toolkit is yours to keep and reuse.
Does this certify my organisation?
No. These are documentation toolkits aligned to the relevant standard to help you prepare. Certification itself is issued by an accredited certification body after their audit. Our toolkits give you a strong, audit-ready starting point.
How is it delivered?
Instantly and digitally. There's no physical shipment — you download the files right after payment and receive a backup link by email.
Do I get updates?
Yes. If we revise this toolkit, you're entitled to the updated version at no extra cost — just contact us with your order details.
What is your refund policy?
Because these are digital products delivered instantly, all sales are final once downloaded. If you have any issue with your files, contact us and we'll make it right. See our Refund Policy for full details.