Your instrument is installed. Is the laboratory ready? We help scope the right studies, review the data, and build documentation that clearly shows what was tested and why.
Part of Connexis Laboratory Compliance Consulting, led by Rick Peluso.
The demonstration went well and a launch date is on the calendar. Before the first patient result is reported, someone has to answer a broader question: what establishes that this laboratory is ready to use this system for its intended testing?
That takes more than an instrument that powers on and produces results. It takes clear study responsibilities, suitable evidence, qualified review, and an operating process the lab can maintain.
Identify the instrument, assays, intended use, regulatory status, and any modifications before deciding what data to collect.
Before reporting patient results, the lab confirms the manufacturer’s performance specifications in its own hands — including accuracy, precision, reportable range, and the appropriateness of reference intervals.
The lab establishes performance specifications itself, which can require additional characteristics and a more extensive study design, defined against the specific method and intended use.
Waived testing shouldn’t automatically be put through the nonwaived verification framework, and a study package that fits one system shouldn’t be assumed to fit every method.
Settle the analysis plan before testing begins — so you don’t discover later that the concentrations, comparison method, or records can’t support the conclusion you need.
Define the performance characteristic, materials, acceptance criteria, and reviewers before collecting results.
Use a fit-for-purpose protocol, records, and data review workflow.
Present results, deviations, limitations, conclusions, and approvals in a coherent file.
Recommend updates when methods, assays, or operating conditions change.
An analyzer can display the right result while an interface sends the wrong unit or maps it to the wrong field. The analyzer’s performance data wouldn’t catch that. Implementation planning covers the whole workflow — procedures, quality processes, staff preparation, result reporting, and escalation — so nothing is left to whoever happens to notice it near launch.
And when results are unexpected, they trigger an evaluation. Changing acceptance criteria after seeing the data just to get a passing conclusion defeats the purpose of the study.
Installation, training, and technical materials — with the scope of that support confirmed up front.
Study materials, testing, technical judgments, and the required approvals.
Planning, data reduction, deviation review, and a documented file your lab understands and owns.
Verification confirms that an unmodified, FDA-cleared or approved test performs to the manufacturer’s specifications in your lab. Validation establishes performance for laboratory-developed or modified methods. Requirements differ, so studies are scoped to the specific test system.
Yes. If your team has already run the study, we can review and reduce the data, investigate deviations, and help assemble the approval package. Your lab still needs to understand the study, the results, and their limitations.
Before collecting results. Defining objectives and acceptance criteria up front avoids re-running studies.
Often, yes. A new assay, a modified process, or a change in intended use may require a fresh evaluation. A well-organized original file gives you a starting point for understanding what was previously established.
Find gaps before the survey team does, and respond with a real plan when a deficiency is cited.
Procedures, competency, PT, and QC documentation that match how your lab actually works.
See the full laboratory compliance practice, led by Rick Peluso.
Tell us the system and timeline so we can define an appropriate support project.
Rick will follow up personally to talk through the study.
