Module GLP-22 · Version 1.0
Writing and Maintaining Controlled Laboratory Documents
A controlled document tells the right person exactly what to do while staying approved, current, traceable, and usable. Covers the document hierarchy, the required content of a procedure, the lifecycle from need through retirement, and how a form becomes a record once it is filled in.
Your next section
Start section 1Read without an account. Sign in to save.
Who this module is for
Bench technologists, technical supervisors, and document owners in a CLIA-certified laboratory who draft, review, approve, or use controlled procedures and forms.
Learning objectives
- Differentiate policy, process, procedure, work instruction, job aid, form, template, and record, and place each correctly in the document hierarchy
- Write clear purpose, scope, responsibilities, materials, steps, safety, QC, limitations, references, and records, including actionable steps with conditional branches and acceptance criteria
- Apply review, approval, revision, training, distribution, access, archiving, and retirement controls so an obsolete document cannot be used and a completed form is protected as a record
How completion works
Mark every required section done and answer every knowledge check in those sections correctly. The final save completes the module automatically.
Sources
7 sources
1. Centers for Medicare & Medicaid Services, State Operations Manual, Appendix C, Section 493.1251 "Standard: Procedure manual," 42 CFR Part 493 (Clinical Laboratory Improvement Amendments), Rev. 233, issued 09-12-2025
Source note · federal regulation
2. Centers for Medicare & Medicaid Services, State Operations Manual, Appendix C, Section 493.1105 "Standard: Retention requirements," 42 CFR Part 493, Rev. 233, issued 09-12-2025
Source note · federal regulation
3. Centers for Medicare & Medicaid Services, State Operations Manual, Appendix C, Section 493.1235 "Standard: Personnel competency assessment policies," 42 CFR Part 493, Rev. 233, issued 09-12-2025
Source note · federal regulation
4. Clinical and Laboratory Standards Institute, QMS02, Developing and Managing Laboratory Documents, 7th edition, published March 11, 2024 (product/abstract/scope page)
Source note · consensus standard
5. Clinical and Laboratory Standards Institute, QMS03, Training and Competence Assessment, 4th edition, published December 30, 2016, reaffirmed January 2021 (product/abstract/scope page)
Source note · consensus standard
6. College of American Pathologists. Laboratory General Checklist, GEN.20375 Document Control (Phase II). CAP Accreditation Program, 12.09.2025 edition.
Source note · accreditation standard
7. LatticeMLS editorial synthesis: reasoning drawn from the regulatory and standards sources above, not itself an external citation
Source note · module-authored