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Acceptance Criteria —

The Real Star of Software Requirements in Lab Software

by

The Semaphore Team

Labs implementing software systems to help them reach their business goals know they need requirements to keep them on track. However, beyond the six common types of requirements — business, user, functional, non-functional, configuration, and user stories — labs should also define clear user acceptance criteria.

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Whether a solution is developed in-house or acquired from a consultant, acceptance criteria are essential. They ensure the software meets not only its intended purpose, but also quality standards and regulatory requirements.

What are acceptance criteria?

Acceptance criteria are the conditions a software product or feature must meet to be accepted by the end user. They serve as a contract between the developers and other stakeholders, including the business team, lab personnel, quality assurance staff, and relevant regulatory organizations. Plus, they provide a concrete definition of when the work is “done.”

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If your lab does business in a regulated environment, you must validate the software to ensure it functions as intended and meets regulations and standards. Acceptance criteria are imperative for completing validation and audit processes.

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Acceptance criteria can also help your lab mitigate risks. By specifying expected behavior and limits, they reduce the likelihood of miscommunication or software errors that could affect lab results or processes. They also help labs align with user expectations by ensuring the software maps to user stories and lab tasks, from sample tracking to data analysis, and they can be used to measure the project’s progress.

What good acceptance criteria look like

When your lab is developing user acceptance criteria, keep in mind that statements should be:

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  • Clear and unambiguous: Criteria should be easily understood by both technical and non-technical stakeholders.
  • Testable: Criteria must be verifiable through testing or demonstration.
  • Relevant: Criteria need to be tied directly to lab workflows, user stories, or regulatory requirements.
  • Measurable: Criteria should be measured against objective conditions.

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Examples of well-defined acceptance criteria include:

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  • “The system must allow users to flag a sample as ‘urgent.’”
  • “System uptime must be 99.9% during operational hours.”
  • “Audit logs must be immutable and stored for a minimum of 5 years.”

How to avoid common acceptance criteria pitfalls

Two common issues arise related to acceptance criteria — statements are often imprecise, or they’re not defined with a view of the entire lab informatics solution, including future strategic directions.

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Labs new to writing acceptance criteria may find their initial attempts are not specific enough. Watch out for vague statements and rewrite them so they are unambiguous, testable, relevant, and measurable. For example, instead of saying “The system should import data quickly,” say “The system must import sample data from a CSV file containing up to 10,000 records within 5 seconds.”

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Some labs also forget to account for scenarios with downstream data or reporting needs, or external integration requirements. To avoid this issue, it’s important to involve and collaborate with the right people on acceptance criteria, such as:

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  • Lab staff to provide workflow and domain knowledge.
  • QA personnel to ensure testability.
  • Regulatory officers to maintain compliance.
  • Developers to ensure feasibility.

Acceptance criteria are the real star of requirements gathering

All forms of requirements have a purpose at various stages within the software development lifecycle. Whether your in-house or consulting team uses Agile or another project management methodology, you should treat acceptance criteria as more than a checkbox. Effectively, they are a key safeguard in software quality, compliance, and user satisfaction.

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If your lab is implementing new software, investing time in defining and agreeing on robust acceptance criteria upfront can help you avoid problems later. In fact, the quality of acceptance criteria can make the difference between a software project that fails and one recognized by stakeholders as a resounding success.

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Contact us for help with defining requirements and acceptance criteria for your lab’s needs.

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