AAMI TIR36-2007 PDF

Full title and description

AAMI TIR36:2007 — "Validation of software for regulated processes". A technical information report that provides guidance and recommended practices for planning, performing and documenting validation of software used to automate regulated quality-system and manufacturing processes (including software that creates or maintains electronic records and manages electronic signatures).

Abstract

This TIR offers a risk‑based, practical approach to software validation for processes subject to regulation (for example, device design, production, testing, labeling, distribution, complaint handling and quality‑system automation). It explains the regulatory context (e.g., QSR/21 CFR 820 and 21 CFR 11), illustrates how to determine the appropriate scope and level of validation effort, and describes planning, execution and documentation practices for controlled computerized/process software. The guidance is non‑normative and intended to help manufacturers and auditors interpret and apply validation expectations.

General information

• Status: Withdrawn / superseded (withdrawn by AAMI; record of supersession noted in distribution outlets).
• Publication date: Published in 2007 (commonly listed as 13 December 2007 by multiple distributors; some catalog listings show a Feb 2008 publication date).
• Publisher: Association for the Advancement of Medical Instrumentation (AAMI).
• ICS / categories: Medical equipment (ICS 11.040) and Information technology / software (ICS 35 — software/informatics).
• Edition / version: 2007 edition (AAMI TIR36:2007).
• Number of pages: Commonly listed as 111 pages in several distributors' records (some vendors list 99 pages); published page counts vary by distributor/format.

Scope

AAMI TIR36:2007 applies to software used to automate any aspect of a medical‑device manufacturer’s regulated processes and quality system (for example, device design, component acceptance, manufacturing, labeling, packaging, distribution, complaint handling, test equipment automation and software that creates, modifies or maintains electronic records or manages electronic signatures). It specifically excludes software that is itself a medical device or software that is a component/part of a device. The TIR is guidance (non‑binding) intended to help determine appropriate validation content and effort for each project.

Key topics and requirements

• Regulatory context and mapping to US regulations (QSR / 21 CFR 820 and 21 CFR 11) and general software‑validation principles.
• Risk‑based determination of validation scope and level of effort (tailoring validation to criticality of the software and its impact on product quality and patient safety).
• Validation planning: validation master plan, requirement specifications (URS/FRS), risk analysis and traceability.
• Qualification and testing activities: installation/operational/performance checks (IQ/OQ/PQ concepts adapted for process software), test protocols and acceptance criteria.
• Documentation and evidence: test records, change control, release/acceptance records, and maintenance of the validated state (revalidation triggers).
• Roles and responsibilities: who plans, executes, reviews and approves validation work; supplier and user obligations.
• Tooling and lifecycle considerations: use of development lifecycle information, configuration management, and auditability of software tools used in regulated processes.

Typical use and users

Primary users are medical‑device manufacturers, quality and regulatory affairs professionals, process owners, validation engineers, IT and software suppliers, and auditors/inspectors seeking practical guidance to plan and perform validation of computerized systems used in regulated processes. The TIR is often referenced by consultants and organizations as a complement to standards such as IEC 62304, ISO 13485 and ISO/TR guidance on software validation.

Related standards

Commonly referenced and complementary documents include IEC 62304 (medical device software lifecycle), ISO/TR 80002‑2 (software validation guidance / process software), ISO 13485 (QMS for medical devices), GAMP guidance for computerized systems, and applicable regulatory texts (21 CFR 820, 21 CFR 11). AAMI published many other TIRs covering related topics; users often cross‑reference those documents for a complete validation strategy.

Keywords

software validation, process software, regulated processes, medical device quality system, 21 CFR 820, 21 CFR 11, computerized system validation, risk‑based validation, IQ/OQ/PQ, AAMI TIR, electronic records, supplier qualification.

FAQ

Q: What is this standard?

A: AAMI TIR36:2007 is a Technical Information Report titled "Validation of software for regulated processes" that provides guidance (non‑normative) on planning, performing and documenting validation of software used to automate processes subject to regulation in the medical‑device context.

Q: What does it cover?

A: It covers the regulatory context, risk‑based scoping, validation planning, testing/qualification activities, documentation requirements, roles/responsibilities, supplier considerations and maintenance of validation status for software that automates regulated manufacturing and quality‑system processes (excluding software that is itself a medical device).

Q: Who typically uses it?

A: Medical‑device manufacturers, validation engineers, QA/RA staff, IT/system owners, suppliers of regulated‑process software, and auditors use the TIR as a practical resource to define validation strategies and deliverables. Consultants and trainers also use it when advising on computerized system validation.

Q: Is it current or superseded?

A: The document has been withdrawn / superseded in AAMI/distributor records (withdrawal recorded in some catalogs; distribution outlets describe the TIR as withdrawn or superseded). Users should rely on current guidance (for example, ISO/TR 80002‑2 and updated industry guidance) and confirm the latest accepted references for regulatory compliance. The withdrawal date recorded by some cataloging services is 10 April 2020.

Q: Is it part of a series?

A: Yes — TIR36 is one of many AAMI Technical Information Reports (TIRs). AAMI publishes multiple TIRs covering validation, sterilization, processing and other medical‑device topics; TIR36 sits in that broader set of guidance documents.

Q: What are the key keywords?

A: software validation, regulated processes, computerized system validation, risk‑based validation, 21 CFR 820, 21 CFR 11, electronic records and signatures, IQ/OQ/PQ, medical device quality system.