IMS for GLP and ISO/IEC 17025 Non-Clinical R&D Labs
IMS for GLP and ISO/IEC 17025 Non-Clinical R&D Labs
Written for laboratories whose studies must remain reconstructable years after the final report has been signed.
Couldn't load pickup availability
Written and reviewed by practising specialists. Who writes this
Built and reviewed with our methodology. Read it
Read the guide: GLP for non-clinical laboratories: what the OECD Principles and 21 CFR Part 58 require
By document type
| Category | Files |
|---|---|
| Manuals | 4 |
| Policies | 3 |
| Procedures & SOPs | 25 |
| Forms & Records | 34 |
| Checklists & Audit Tools | 8 |
| Registers, Logs & Matrices | 3 |
| Job Descriptions & Organisation | 2 |
| Training & Awareness | 2 |
| Guides & Work Instructions | 6 |
Key documents
| Reference | Document | Format |
|---|---|---|
| AGS-QM-01 | Integrated Quality Manual | Word |
| AGS-QP-12 | Study Plans, GLP Study Conduct and Study Director Responsibilities | Word |
| AGS-QP-10 | Method Selection, Verification and Validation | Word |
| AGS-QP-23 | Data Integrity and Information Management (ALCOA+) | Word |
| AGS-F-19 | GLP Study Plan | Word |
| AGS-F-04 | Personnel Competence and Authorisation Matrix | Word |
- Need the complete document list? Request it — same day
- Want to check the quality first? Preview free samples
Overview
Non-clinical research and development laboratories running safety and regulatory studies answer to monitoring authorities and study sponsors, not only to accreditation bodies. This integrated system brings the OECD Principles of Good Laboratory Practice, FDA 21 CFR Part 58, ISO/IEC 17025, ISO 15189 and ISO 9001 into one controlled framework built around study integrity: study plans and protocols, Study Director and personnel responsibilities, test-item characterisation and handling, standard operating procedures, raw-data capture, archiving and final report certification. A quality assurance programme independent of study conduct supplies the inspections and audits that GLP requires.
An integrated quality manual and a compliance scheme map each principle to a control. Procedures run across organisation and impartiality, facilities and environmental conditions, equipment calibration and metrological traceability, handling and storage of test and reference items, method selection, verification and validation, sampling, evaluation of measurement uncertainty, and ensuring the validity of results. Guidance addresses data integrity and the ALCOA+ principles, decision rules and statements of conformity, and GLP principles for non-clinical studies, while chain-of-custody records, study plans and certificates of analysis carry the day-to-day evidence. The ISO/IEC 17025 and ISO 15189 layers add technical-competence rigour for analytical and bioanalytical work.
What this system covers
- GLP study lifecycle — study plans and protocols, Study Director responsibilities and final report certification
- Independent quality assurance — a GLP quality assurance unit programme kept separate from study conduct
- Test and reference items — receipt, chain of custody, characterisation, storage and retention
- Data integrity — raw-data capture, ALCOA+ principles, data change control and archiving
- Analytical competence — method verification and validation, measurement uncertainty, sampling and decision rules
- Facilities and equipment — calibration periodicity, performance verification, environmental monitoring and biosafety inspection
- People — competence and authorisation matrices, deputising arrangements and training effectiveness
- Reporting and release — certificates of analysis, report review, and acceptance criteria for internal quality checks
Who it's for
Contract research organisations, toxicology and bioanalytical laboratories, and research facilities preparing for inspection by a GLP monitoring authority or for a sponsor's audit. Study directors, quality assurance staff and quality managers adapt the documents to their study types, test systems and facilities. The outcome is a laboratory in which study conduct, raw data and independent quality assurance are systematised, and a completed study can be reconstructed from its records on request.
Everything you get
Every toolkit gives you a full set of working documents for your standard, ready to edit and use.
Native Microsoft files. Add your logo and adapt every document to how you work.
Your full toolkit arrives as a ZIP the moment payment clears.
Any of your staff, at any of your own sites. No per-seat fees.
Sector specialists author each toolkit. A principal reviewer with more than twenty years reviews it.
One payment, perpetual licence for your organisation. No subscriptions, no renewals.
If a document is wrong, missing or not as described, tell us within 14 days. We fix it or refund you.
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, for 12 months. Fixes and revisions to this toolkit are free for 12 months from your order. Email us with your order number to get them.
What is your refund policy?
If a document is wrong, missing or not as described, tell us within 14 days of your order. We fix it or refund you. If you have not downloaded yet, we can cancel the order and refund you in full. We don't refund a change of mind after download. See the Refund policy.
Cannot find your standard?
Tell us which scheme you work to. We will point you to the right toolkit.
More in Quality, Excellence & Accreditation
See all 78
Integrated Certification Body Management System (ISO/IEC 17021-1, 14 Schemes)
Quality, Excellence & Accreditation110 documents $1,690USD
Food Establishment Inspection Body Management System (ISO/IEC 17020)
Quality, Excellence & Accreditation57 documents $1,900USD
Personnel Certification Body Management System (ISO/IEC 17024)
Quality, Excellence & Accreditation52 documents $690USD