How to Build a Data Review Workflow in Waters’ Empower™ Software

Empower™ is Waters’ chromatography data system. Most HPLC and UPLC labs use it to acquire, process, and store data.

If you regularly use the system in your work, you might think that a chromatogram in a report and a chromatogram in Empower™ are the same thing. But they are not.

This article covers the decisions that determine whether your current chromatography data review is sufficient to catch issues and, if not, how you can fix it.

Report Chromatogram vs. Empower™ Chromatogram

In a report, you can see a chromatogram’s peaks, baseline, final results, and confirm everything looks as you expect. But only in Empower™ can you interrogate the data behind those results.

For example, in a report, you can’t see which integration parameters applied to which region of that chromatogram, or which timed events were in force where. Open the same data in Empower™, and the integration type shown against each peak tells you whether a peak’s start or end was set manually.

In Empower™, manual integration is noted in the Int Type field with lowercase letters; bv is a manual baseline to valley, whereas BV is automatic [1, 2]. You can also work between the chromatogram and the processing method that produced it to see which parameters and events applied where.

A report can flag that a manual integration occurred, but only if it has been set up to. With Empower’s™ exception-focused review approach, you build a Boolean custom field that flags manual integration at the peak and result level, then surface it in the report method to alert the reader [3]. You can do the same with a view filter on the Results tab to pull up every manually integrated result in a project [4].

So a report can tell you what the result is, but Empower™ lets you judge whether it’s right.

Empower™ is More Than a Database

The Empower™ database holds your processed results, sample identifiers, methods, and associated metadata.

• The raw data files themselves sit outside it as .dat files in the project folder on a configured raw data path and are usable only within the project context. That means if you delete one, the chromatogram remains in the database but is no longer reviewable [5,6].
• Waters states that data in the Empower™ database is not overwritten, and that methods are versioned. That means when you modify a method and save it under the same name, the version increments, with earlier versions remaining accessible and comparable in Method Properties [7,8].
• Waters also states that when methods or sequences are updated, Empower™ retrieves the version used for any reported result [9]. This means that the record of what was done, and with which version, should still be there to find.

What protects the electronic record is the set of controls around it, i.e., your privilege configuration, your storage and backup arrangements, and your retention arrangements.

Appropriately privileged users can still remove objects, which is precisely why those privileges should be controlled [10]. These controls need to be deliberately set up and verified.

Four Questions to Determine Where to Check Your Chromatogram Data

A comprehensive report with everything in one place, printed, signed, and archived can feel like the simplest, most effective option. But while a report can display a chromatogram, it does not let your reviewer perform all the necessary data checks.

Here are four questions to help you determine whether a reviewer needs to check the chromatogram data in Empower™ or in your report.

Question 1: Which Checks Only Work if You Can Interrogate Them?

This is the first question I ask of every item on your critical list: Can I form the judgment I need from a static presentation, or do I need to interrogate the underlying data?

If your answer is the latter, the check belongs in Empower™. Here’s what to look at:

• The chromatogram itself: peak shape, baseline noise, etc.
• Integration: whether peaks were integrated appropriately, including whether any flagged manual integrations were justified.
• The processing method: its integration parameters and timed events.
• Anything that has turned into a question: an exception, an unexpected second result set for a sample set, or an audit trail entry that needs following. A well-designed report can raise the question, but it can almost never answer it.

Empower™ gives you excellent access to the original data and distributes it across windows and views. But if your reviewers don’t know what to review or where it lives, it doesn’t matter. If you’re building an onboarding program for reviewers, I’ve written separately about why teaching less at the start produces a reliable analyst sooner.

Question 2: Which Checks are Better as a Structured Summary?

The second question to ask: Is this an item I judge by comparing a value against a criterion?

If the answer is yes, a report will usually beat interactive review because it makes comparison easy. Include the acceptance criteria alongside the results, system suitability parameters, and critical calculated values being judged.

In a hybrid workflow, the report should be a focused summary that quickly tells the reviewer which values need their attention. You can build this into the report method itself by adding the criteria and any explanatory text, so the reviewer doesn’t have to remember them or look them up elsewhere.

Making exceptions visible will also help new starters who are less familiar with your workflow. Rather than needing to know where everything lives and what every number means, they can use a report built around the most relevant assessments as a solid starting point.

Question 3: Which Checks Shouldn’t Need a Human at All?

The third question asks: Does a person need to look for this exception, or can the data review system signpost it?

If a value falling outside a defined criterion is something the software can identify, you don’t want a reviewer scanning a hundred values hunting for it. Ideally, you want Empower™ to flag it so they can decide what it means and whether it needs investigating.

The tools available for delegating these checks are included in Table 1 below:

Limits	The Limits tab in the processing method lets you set a target value with upper and lower error and warning limits; values outside them are faulted and appear in a different color and font in both Review and printed reports.
Custom fields	Including Boolean and enumerated fields, which can carry out a calculation check and return a text verdict for inside or outside criteria.
View filters	To display and sort the relevant information for a particular review step, consistently.
Report methods	To design a report for the review, rather than adapting one built for something else.

Limits vs Custom Fields

Keep in mind that delegating these checks doesn’t negate responsibility. Limits are easier to set up, but that ease can become a trap. If someone reuses or copies a processing method for a new analysis, the old limits travel with it, and then, inevitably, nobody checks that they still match the current criteria. Limits also constrain you to entering values into certain tables.

Also, not every installation has access to limits, so check what’s available before you design a workflow around them:

• Suitability Limits are available with the System Suitability option, a licensed Empower™ option activated through the Waters Licensing Wizard. This option adds system suitability calculations, tables for setting limits and acceptance criteria, and summary charts for tracking trends. You can enable or disable the option for individual projects, so check that it’s switched on in the project you’re using.
• Interactive System Suitability, by contrast, is a function of the base software and doesn’t require the licensed option. It detects faults during acquisition and lets you choose how the run responds, such as stopping, reinjecting, or moving to the next sample [1].

Custom fields might take more work to configure, but you can lock them. Empower™ carries separate privileges for creating, altering, deleting, locking, and unlocking custom fields, which tends to make them safer for the evaluations you most need to trust [11].

Both approaches work well. The right choice depends on your license, how often your methods are copied or reused, and how tightly you need to control the evaluation.

Question 4: What Could Go Wrong Here?

The previous questions assume you already know what items are critical for your data review, but building that list requires separate work. To create it, ask: What could go wrong here, and how would we detect it?

Working through one method, that list looks like this:

1. What can affect the result? Instrument method, sample preparation, reagents, standards, processing-method parameters, system-suitability settings, etc.
2. What can the analyst change?
3. What must the reviewer verify to be confident the result is valid?
4. Which parameters are genuinely critical, as opposed to merely available?
5. Where is each one most efficiently reviewed?

Keep in mind that this list is method-specific. What is critical for an assay method will differ from what’s critical for an impurity or dissolution method.

How the “Locking” Function Can Help

If your instrument method parameters are fixed for routine analysis, lock the method. A locked method can’t be amended or changed and saved under the same name, but it can still be used, and unlocking it requires a specific privilege [12, 13].

However, keep in mind that locking doesn’t set your review scope. Your validated workflow, SOPs, risk assessment, and applicable requirements determine whether the reviewer must still verify the method, its version, or associated information on each run.

A Common Problem in Empower™ Data Review

Unfortunately, you can make every placement decision correctly in your data review workflow and still end up with three different review processes!

This is because asking your colleagues to “Review the analytical data and ensure the results are acceptable” leaves undefined what to check, where to find it, and what to do when something looks wrong. As a result, one reviewer checks ten things, another checks twenty, and a third prints the whole analysis and works through every page.

All three reviewers are trying to do the job properly, but none of them is doing the same job!

The Solution: Write it Down

If you recognize this problem, you may have a gap between what your review procedure says and what people were shown to do. So you need to better define the review workflow: what is reviewed, in what order, and where.

Your sequence might run from sample information, to the chromatogram and integration, to the processing method, to system suitability, to critical results and calculations, to highlighted exceptions, and finally to documentation and sign-off.

The order that suits your lab depends on your procedures and your method. What matters is that it’s clearly defined, and not left to individual habit. Here are three specific Empower™ fixes that can help:

1. Create Public View Filters

Rather than leaving reviewers to build their own filters, create public view filters. Anyone with access to the project can use these, whereas a private filter is visible only to its creator.

To make a filter public, you need the Make View Filter Public privilege, which lets you copy filters across projects [14, 15]. That way, every reviewer who selects the filter sees the same view.

2. Decide Your Sign-off Levels

Empower™ provides two sign-off levels, configured under System Policies [16]. Both levels can be used multiple times, depending on your laboratory’s procedures and workflow. A common approach is to use the first level for the analyst to confirm that the analysis has been completed and meets the required criteria, and the second level for an independent review. You can also apply the same sign-off level at different stages of the workflow, if needed.

3. Be Precise About Locking

A locked channel can’t be processed:

• If a channel is locked after the data has been reviewed and signed off, you can still review the data, but no further results can be generated. [16, 17]
• Unlocking is available to a user holding the Unlock Channels privilege [18], so this isn’t a door closing forever.

Note that channel locking doesn’t govern every change to a sample set. Sample set method editing is a separate privilege question, and worth settling separately. I’d still recommend locking completed channels where that’s part of your approved workflow, as it stops results being regenerated from data you have already signed.

One Final Question to Test the Placement

This final step tells you whether any of the above worked, so don’t skip it!

When a new review workflow is ready, most teams check that the report renders and the custom fields calculate correctly. That’s a useful technical check, but it doesn’t test the review itself. If you only run the workflow on data where nothing has gone wrong, you’ll know it works, but not whether it catches problems.

So, test the workflow against the situations you built it for. What happens if:

• System suitability fails?
• A peak is manually integrated?
• A calculation produces an unexpected value?
• A critical parameter is changed?

For each one, ask: Would the reviewer, following this workflow, actually catch this?

What’s under test is the whole review process: from the data, through Empower™, through the report, to the person. If a failure travels all the way to a signature, you have found a placement decision that needs revisiting. And much better to find it here than during a real analysis!

Key Takeaway

Documenting placement decisions and the reasons behind them gives you a rationale for your data review workflow that you can explain to an auditor, hand to a new reviewer, and revisit when the method changes.

And once you’ve built a data review workflow for one method, you can transfer the general principles to another, so you’re not starting from zero: which checks belong in the report, which need review in Empower™, and how you approach the audit trail. Only the method-specific parts, like particular criteria, calculations, custom fields, and report sections, will need to be added.

If you’re looking to build or improve your Empower™ onboarding program, LabWissen supports laboratories with practical, GMP-compliant Empower™ training, onboarding programs, competency development, and workflow optimization—all tailored to your laboratory’s workflows and requirements.

References

1. Waters Corporation — Empower™ System Suitability Quick Reference Guide (Suitability Limits and configuration). [Accessed 09 September 2026]
2. Waters Corporation — How to Easily See That a Peak Has Been Manually Integrated (Tip #363) [Accessed 09 September 2026]
3. Waters Corporation — Exception Focused Review: Identifying Manually Integrated Peaks in Results (Tip #291). [Accessed 09 September 2026]
4. Waters Corporation — How do I determine if a result has been manually integrated in Empower? – WKB74951 [Accessed 09 September 2026]
5. Waters Corporation — What are the .dat files in the Empower™ Projects folder? (WKB107328 — database content and raw data file storage). [Accessed 09 September 2026]
6. Waters Corporation — Where can I find the Raw Data Path in Empower? – WKB13277 [Accessed 09 September 2026]
7. Waters Corporation — Empower Software Functionality (April, 2004) [Accessed 09 September 2026]
8. Waters Corporation — How to Create Multiple Versions of the Same Method in Empower (Tip #242) [Accessed 09 September 2026]
9. Waters Corporation — Empower Chromatography Data System (CDS) [Accessed 09 September 2026]
10. Waters Corporation — Empower™ Access Levels (privileges, method locking, sample set method changes). [Accessed 09 September 2026]
11. Waters Corporation — Where can I find a summary of Empower 3 Administrator User Type permissions? – WKB232941 [Accessed 09 September 2026]
12. Waters Corporation — Can you lock an instrument method in Empower to prevent it from being used? – WKB20120 [Accessed 09 September 2026]
13. Waters Corporation — How to unlock a locked method in Empower – WKB65195 [Accessed 09 September 2026]
14. Waters Corporation — How do you create a view filter, make it public and copy it to other projects in Empower? – WKB82159 [Accessed 09 September 2026]
15. Waters Corporation — Empower Tip: Creating and Using View Filters (Tip #166) [Accessed 09 September 2026]
16. Waters Corporation — What does the option “Lock channels after signoff” mean? (WKB463). [Accessed 09 September 2026]
17. Waters Corporation — Can I process a locked channel in Empower? – WKB65396 [Accessed 09 September 2026]
18. Waters Corporation — In Empower 3, how do you unlock channels locked during sign-off? – WKB201284 [Accessed 09 September 2026]