SOP University · Glossary
SOP Glossary: 44 Standard Operating Procedure Terms Defined
Best SOP Software reviewers · From vendor pricing, help-centre and product pages · Evaluated September 2026
Plain answer
This glossary defines 44 terms used when writing, running and buying SOP software, from acknowledgement to work instruction, including regulatory terms such as 21 CFR Part 11, Annex 11 and the FDA QMSR. Each definition is one to three sentences and links to the lesson, guide or source that covers it in depth.
- 21 CFR Part 11
- The US FDA regulation on electronic records and electronic signatures, including requirements for audit trails (11.10(e)). Source
- Acknowledgement
- A record that a person has read a specific version of an SOP, by a click, quiz or signature. Read more
- Annex 11
- Annex 11 of the EU GMP guidelines, which covers computerised systems used in regulated manufacturing. Qualio states its e-signatures meet it as well as FDA 21 CFR Part 11. Read more
- Approval workflow
- The route a draft SOP takes to a named approver, who accepts or rejects it, with the outcome recorded. Read more
- Audit trail
- A time-stamped record of who created, changed, approved or deleted a document and when. Read more
- CAPA
- Corrective and preventive action: the process for fixing the cause of a problem and preventing it from recurring, often triggered by a deviation or audit finding. Read more
- Capture-first tool
- A tool that records a task as someone does it, click by click, and turns it into a step-by-step guide with screenshots. Haiku, Scribe and Tango work this way. Read more
- Change control
- The formal process for requesting, reviewing, approving and recording a change to a controlled document or process. Read more
- Change request
- A formal request to change an SOP that says what should change and why. It starts the change control process. Read more
- Checklist
- A compact list of items to confirm, used as an SOP format for routine tasks. Read more
- Computer software assurance (CSA)
- FDA's risk-based approach to gaining confidence that software used in production or quality systems works as intended. FDA issued final guidance on it on 3 February 2026. Read more · Source
- Conditional logic
- Rules in a checklist or workflow that show, hide or route steps based on earlier answers. Process Street lists it on every plan. Read more
- Controlled document
- A document whose versions, approvals and distribution are managed so that only the current approved version is in use. Read more
- Deviation
- A departure from a written procedure. In drug manufacturing, 21 CFR 211.100(b) requires deviations to be recorded and justified. Source
- E-signature
- An electronic signature on a record. For FDA-regulated records, Part 11 sets the controls it must meet. Read more
- Effective date
- The date from which a version of an SOP must be followed. Read more
- In-app guidance
- Help shown inside the application where the work happens, such as a walkthrough, instead of in a separate document. Tango lists Guide Me and Pins on its Enterprise plan. Read more
- ISO 13485
- The international standard for quality management systems for medical devices. FDA's QMSR incorporates the 2016 edition by reference. Read more · Source
- Knowledge base
- A searchable collection of articles built for finding answers. Unlike SOP software, it does not usually manage approval, versioning or proof of training. Read more
- Model Context Protocol (MCP)
- An open protocol that lets AI assistants call tools and read data in other systems. Several SOP tools offer an MCP server so agents can read procedures. Read more
- Owner
- The role accountable for keeping an SOP accurate and reviewing it on schedule. Read more
- Periodic review
- A scheduled check that an SOP is still accurate, even if nothing has prompted a change. Read more
- PII redaction
- Hiding personal data such as names, email addresses or account numbers in screenshots and text before an SOP is shared. Several capture tools offer it, often on paid plans. Read more
- Platform fee
- A fixed charge for a workspace or account, instead of or on top of per-user prices. Tango prices its Enterprise plan as a platform fee. Read more
- Policy
- A statement of what must be true and why; the SOP describes how it is achieved. Read more
- Process map
- A diagram of a process across steps, decisions and teams, less detailed than an SOP. Read more
- Proof of concept (POC)
- A short, structured trial of a tool on your own content, run to check it meets your requirements before you buy. Read more
- QMSR
- The FDA Quality Management System Regulation for medical device makers. It took effect on 2 February 2026 and replaced most of 21 CFR Part 820 with ISO 13485:2016, incorporated by reference. Read more · Source
- Read assignment
- Assigning an SOP to named people and tracking that each has read the current version. Read more
- Review interval
- The set time between periodic reviews of an SOP, recorded in its header. Whale lists Review Intervals that prompt owners to re-check SOPs. Read more
- Revision history
- The section or log that lists each version of an SOP, the date, what changed and who approved it. Read more
- Role-based access control (RBAC)
- Granting permissions by role, such as author, approver or reader, rather than person by person. Read more
- SAML
- Security Assertion Markup Language, an open standard many single sign-on setups use to pass a user's sign-in from an identity provider to an application. Read more
- SCIM
- System for Cross-domain Identity Management: a standard for creating, updating and removing user accounts automatically from an identity provider. Read more
- SCORM
- A packaging standard for e-learning content, used to load training material into a learning management system. Read more
- Seat minimum
- The smallest number of paid seats a plan requires. Haiku's Team plan and Scribe's Pro Team plan both publish a 5-seat minimum. Read more
- Single sign-on (SSO)
- Signing in to several applications with one company identity, often through SAML. On many SOP tools it is on a higher plan. Read more
- SOC 2 Type II
- A report from a CPA firm on how a service provider's security controls operated over a period of time, based on AICPA criteria. Several SOP vendors state they hold one. Read more
- Standard operating procedure (SOP)
- A written, approved description of how a recurring task is done, by whom, and how completion is checked. Read more
- Step recorder
- A capture feature that records each click or action and turns it into a numbered step with a screenshot. Whale lists a Step Recorder. Read more
- Superseded version
- An earlier version of an SOP that a newer approved version has replaced. It is kept for the record but must not be used. Read more
- Training path
- An ordered set of SOPs, lessons and tests assigned to a role, such as new-hire onboarding. Trainual lists role-based training paths. Read more
- Version control
- Numbering each change to a document, keeping earlier versions and knowing which one is current. Read more
- Work instruction
- Detailed steps for one task at one station or screen, more specific than the SOP it supports. Read more