TL;DR
- What this is: SAP PLM quality workflow automation, SAP GUI, Fiori, 21 CFR Part 11
- Who it affects: QA and regulatory teams at pharma, biotech, medical device companies
- The core problem: SAP GUI thick client invisible to web automation tools
- Cost of not solving it: Manual SAP evidence collection delays FDA submissions
- What Sahi Pro does differently: SAP GUI add-on, 21 CFR Part 11 records, on-premise deployment
- Proof: ArisGlobal, 70% reduction in report generation time
Life sciences QA teams running sap PLM test automation against SAP GUI quality management transactions know the fundamental gap: standard web testing tools cannot see the SAP GUI thick client. CAPA workflows, deviation records, and batch release transactions execute inside a Win32 scripting layer that Selenium, Playwright, and browser-based recorders simply do not reach. Choosing a tool for SAP PLM with SAP GUI and Fiori requires evaluating not just UI coverage, but also 21 CFR Part 11 electronic record output, on-premise data residency for FDA compliance, and GAMP 5 Category D documentation readiness. This article evaluates six tools against those criteria, scored specifically for pharmaceutical, biotech, and medical device teams running SAP PLM quality workflows across SAP GUI and Fiori. Each tool was assessed on its ability to automate SAP GUI quality transactions natively, produce compliant execution records, and deploy fully on-premise.
Quick-Pick: 6 SAP PLM Life Sciences Test Automation Tools at a Glance
| # | Tool | Best for | SAP GUI quality and compliance coverage | On-premise |
| 1 | Sahi Pro | SAP PLM quality workflows with 21 CFR Part 11 records and on-premise FDA data residency | SAP add-on for SAP GUI quality workflows + 21 CFR Part 11 records + on-premise for FDA data residency | Yes, full |
| 2 | Worksoft Certify | SAP-primary PLM teams with no scripting resource | Deepest SAP PLM coverage with no-code authoring | Yes, on-premise available |
| 3 | Tricentis Tosca | Enterprise teams already using Tosca for SAP | Model-based test design and SAP-native integration | Yes, on-premise available |
| 4 | OpenText UFT One | Teams with existing UFT investment and legacy PLM | Broadest legacy technology coverage | Yes, on-premise available |
| 5 | Leapwork | Non-developer PLM QA in regulated life sciences | Most accessible visual no-code for regulated industries | Partial, cloud-primary with limited on-premise |
| 6 | Tricentis qTest | PLM test management and compliance documentation | Best PLM test management and compliance reporting | Yes, on-premise available |
1. Sahi Pro: Best for SAP PLM quality workflows in life sciences with 21 CFR Part 11 compliance
Why it ranks first for SAP PLM with SAP GUI and Fiori
The core challenge in sap PLM test automation for life sciences is bridging two distinct technology layers in a single test execution: SAP GUI thick client transactions (CAPA, deviation management, batch release) and SAP Fiori web-based quality apps. Sahi Pro’s SAP add-on connects directly to the SAP GUI scripting API, enabling these quality management transactions to be automated natively without a separate VBScript layer. The same test script that drives an SAP GUI batch release transaction can switch to a Fiori document management app using the Web add-on. No tool-stitching. No middleware.
For verification and validation testing in regulated pharma environments, this single-script architecture matters because it produces one continuous execution record across both technology layers. Auditors reviewing IQ/OQ/PQ packages see a single timestamped trail, not spliced logs from two different tools. That traceability is what separates a passing FDA audit from a finding.
Key capabilities for SAP PLM with SAP GUI and Fiori teams
- SAP GUI scripting API integration: The SAP add-on reads SAP GUI controls natively, automating CAPA, deviation, and batch release transactions without screen-scraping or image-based workarounds.
- 21 CFR Part 11 electronic records: Timestamped, structured execution records per test step satisfy Subpart C requirements for SAP PLM electronic records, formatted for direct inclusion in IQ/OQ/PQ validation packages.
- On-premise deployment for FDA data residency: Full installation with no external data routing. License activation, execution, and result storage stay within the company network, which is non-negotiable for PLM qa automation in pharma and biotech.
- Fiori and SAP GUI in one script: The Web add-on covers SAP Fiori quality apps alongside SAP GUI transactions in a single test sequence, eliminating coverage gaps between layers.
- GAMP 5 Category D documentation: Vendor-supplied documentation supports CSV validation programmes for SAP PLM deployments in life sciences.
Honest limitations
The SAP add-on and AI Assist OCR module are separate add-ons at additional cost, not included in the base license. Teams that need only web-layer Fiori testing may find the full SAP GUI add-on unnecessary for their scope. The BDTA visual builder covers web-layer flows primarily; SAP GUI thick-client steps require scripted automation within the same project.
Best for: SAP PLM quality workflows with 21 CFR Part 11 records and on-premise FDA data residency On-premise: Yes, full installation, no external routing Pricing: Module-based; free trial available Key SAP PLM capability: SAP add-on for SAP GUI quality workflows + 21 CFR Part 11 records + on-premise for FDA data residency
2. Worksoft Certify: Best for SAP-centric PLM teams requiring no-code test authoring
Overview for SAP PLM with SAP GUI and Fiori teams
Worksoft Certify is a no-code test automation platform purpose-built for SAP environments. PLM teams with SAP PLM as their primary system evaluate it for business process automation across SAP GUI and Fiori without scripting. Its deep SAP integration and large installed base at Fortune 500 SAP shops make it a natural shortlist candidate for teams that lack dedicated automation engineers.
What it does well for SAP GUI quality management workflows with 21 CFR Part 11 compliance evidence for life sciences
- Purpose-built SAP coverage: Certify was designed for SAP from the ground up, with deep support for S/4HANA, SAP GUI, and Fiori quality transactions.
- No-code process recording: Business analysts can record SAP quality workflows directly, reducing dependency on automation specialists for test creation.
- BAPI and RFC validation: Certify validates backend SAP data through BAPI and RFC calls, enabling end-to-end verification of quality management transactions beyond the UI layer.
- Large SAP installed base: Extensive deployment across Fortune 500 SAP environments means strong community knowledge and documented patterns for SAP PLM workflows.
Best for: SAP-primary PLM teams with no scripting resource On-premise: Yes, on-premise available
3. Tricentis Tosca: Best for enterprise model-based PLM automation
Overview for SAP PLM with SAP GUI and Fiori teams
Tricentis Tosca is a model-based test automation platform widely used in SAP and enterprise application environments. PLM teams consider it when they need a risk-based regression approach or already have Tosca deployed for SAP ERP testing. Its model-based design philosophy reduces test duplication across similar PLM workflows, which is relevant for pharma teams managing dozens of near-identical quality management transaction variants.
What it does well for SAP GUI quality management workflows with 21 CFR Part 11 compliance evidence for life sciences
- Model-based test design: Tosca’s model approach creates reusable modules across similar PLM workflows, reducing maintenance when SAP PLM transaction screens share common field structures.
- SAP-native integration: Teams already running Tosca for SAP ERP testing can extend their existing models to cover PLM quality management transactions without starting from scratch.
- Risk-based regression coverage: Tosca’s risk scoring engine prioritizes test execution based on change impact, helping regulated teams focus validation effort where it matters most.
- No-code test design for business analysts: The model-based approach lets analysts familiar with Tosca’s interface build and modify PLM test cases without scripting.
Best for: Enterprise teams already using Tosca for SAP On-premise: Yes, on-premise available
4. OpenText UFT One: Best for legacy PLM with existing UFT investment
Overview for SAP PLM with SAP GUI and Fiori teams
UFT One (formerly HP QTP) is a long-established enterprise test automation tool with broad technology coverage. PLM teams evaluate it when they have legacy test scripts, existing UFT licenses, or need VBScript-based automation for older PLM interfaces. Its longevity in enterprise environments means many pharma companies already have UFT infrastructure and institutional knowledge in place.
What it does well for SAP GUI quality management workflows with 21 CFR Part 11 compliance evidence for life sciences
- Broad technology coverage: UFT One supports Java, web, Windows, and SAP technologies, covering the range of interfaces that older SAP PLM deployments typically present.
- Existing script libraries: Many enterprise environments have years of UFT scripts already written. Migrating away from UFT means abandoning that investment; staying means extending it to PLM quality workflows.
- Object spy for SAP GUI elements: UFT’s object identification can inspect SAP GUI controls and Java Swing elements, providing a path to automate quality management transactions in thick-client interfaces.
- Mature enterprise support: Decades of documentation, community forums, and enterprise support agreements reduce the risk of adopting UFT for teams already in the OpenText ecosystem.
Best for: Teams with existing UFT investment and legacy PLM On-premise: Yes, on-premise available
5. Leapwork: Best for non-developer PLM teams with visual flowchart automation
Overview for SAP PLM with SAP GUI and Fiori teams
Leapwork is a visual no-code automation platform using drag-and-drop test design. PLM teams whose QA staff is entirely non-developer look at it as an alternative to scripted tools, particularly in life sciences and regulated industries. Its visual interface lowers the barrier to test creation, which appeals to teams where domain experts, not engineers, own the quality process.
What it does well for SAP GUI quality management workflows with 21 CFR Part 11 compliance evidence for life sciences
- Fully visual no-code test design: Tests are built by arranging blocks in a visual canvas, making automation accessible to non-technical testers and regulatory staff.
- Audit-ready test documentation: Leapwork generates structured test documentation suitable for regulated industry audits, including timestamped execution evidence.
- Life sciences focus: Leapwork has invested in life sciences marketing and partnerships, resulting in pre-built templates and guidance for regulated workflows.
- Drag-and-drop accessibility: Non-technical testers can build and modify test flows without learning a scripting language, which reduces the bottleneck on automation specialists.
Best for: Non-developer PLM QA in regulated life sciences On-premise: Partial, cloud-primary with limited on-premise
6. Tricentis qTest: Best for managing PLM test cases alongside Jira in ALM
Overview for SAP PLM with SAP GUI and Fiori teams
Tricentis qTest is a test management platform that integrates execution automation from multiple tools including Tosca and Selenium. PLM teams that need centralized test management for compliance documentation evaluate it alongside a separate automation tool. It does not execute tests itself but orchestrates and reports on execution from other engines.
What it does well for SAP GUI quality management workflows with 21 CFR Part 11 compliance evidence for life sciences
- Jira integration for PLM test case management: qTest connects directly to Jira, enabling PLM teams to link test cases to requirements and track coverage in one place.
- Compliance-ready documentation: qTest produces audit trail reports and traceability matrices suitable for FDA and ISO 13485 compliance submissions.
- Multi-tool execution support: Teams using different automation tools for different PLM layers can consolidate results in qTest for unified compliance reporting.
- Audit trail for test results: Every test execution, result, and status change is logged with timestamps, supporting 21 CFR Part 11 record-keeping requirements at the management layer.
Best for: PLM test management and compliance documentation On-premise: Yes, on-premise available
How to choose the right SAP PLM Life Sciences Test Automation Tools
Selecting the right tool depends on your specific SAP PLM environment, team composition, and regulatory requirements. Here is a practical decision framework.
- If your QA team has no dedicated automation engineers and needs manual testers or regulatory staff to build tests, consider Sahi Pro’s BDTA visual builder for web-layer flows or Worksoft Certify’s no-code recording for SAP GUI transactions. Both reduce dependency on developer resources.
- If your SAP PLM quality workflows require SAP GUI thick-client coverage for CAPA, deviation, or batch release transactions, eliminate any tool that operates on web DOM only. Leapwork’s cloud-primary architecture and qTest’s test-management-only scope will not cover this layer. Sap test automation for thick-client SAP GUI requires a tool with native scripting API access.
- If your pharmaceutical or biotech environment requires on-premise deployment with no SAP quality workflow data leaving the company network, eliminate cloud-only options at this step. Check the on-premise column in the quick-pick table above. Leapwork’s partial on-premise support may not satisfy FDA data residency requirements.
- If your scope is purely web-layer SAP Fiori quality app testing with no SAP GUI thick-client transactions, a standard web automation tool may be sufficient. You may not need the SAP GUI add-on at all.
- If you need one test suite covering SAP PLM quality workflows and SAP ERP integration in one execution, only Sahi Pro’s add-on architecture covers both SAP GUI and Fiori layers in a single script. This matters for sap PLM test automation scenarios where a CAPA workflow triggers downstream ERP transactions.
If you are unsure which criteria apply to your deployment, run a proof-of-concept directly against your SAP PLM with SAP GUI and Fiori environment. Sahi Pro offers a free trial for this purpose.
How we evaluated SAP PLM Life Sciences Test Automation Tools
A generic sap test automation tool can drive browser-based interfaces. That is table stakes. The differentiator for SAP PLM in life sciences is whether the tool can reach SAP GUI quality management transactions natively, produce 21 CFR Part 11 compliant execution records, and deploy entirely on-premise. Every tool in this list was assessed against criteria specific to sap PLM test automation for pharmaceutical, biotech, and medical device companies.
- SAP GUI quality management workflow coverage: Can the tool reach SAP PLM CAPA, deviation, and batch release transactions via the SAP GUI scripting API, not just through screen-scraping or image recognition.
- 21 CFR Part 11 electronic record output for SAP: Does the tool produce timestamped, structured execution records satisfying Subpart C requirements for SAP PLM quality workflows, suitable for direct inclusion in verification and validation testing documentation.
- On-premise for pharma FDA data residency: Can the tool run fully on-premise with no SAP quality workflow data leaving the company network. Cloud-only vendors fail this criterion by default.
- SAP Fiori quality app coverage alongside SAP GUI: Can the tool cover both SAP Fiori quality apps and SAP GUI transactions in one test script, or does it require separate tools for each layer.
- GAMP 5 Category D documentation for SAP PLM: Does the vendor provide GAMP 5 Category D self-assessment documentation supporting CSV validation in life sciences.
- IQ/OQ/PQ evidence from SAP quality execution: Are SAP PLM execution records formatted for direct inclusion in IQ/OQ/PQ validation packages, or does the team need to manually reformat output.
Life Sciences: 21 CFR Part 11 for SAP PLM Quality Workflows
FDA 21 CFR Part 11 Subpart C requires electronic records for all quality management transactions that influence product release decisions. SAP PLM CAPA and batch release workflows fall under this requirement [21 CFR Part 11, Subpart C, Section 11.10]. The specific mandate: every automated test execution against these transactions must produce a timestamped, attributable, tamper-evident record. The test automation tool itself becomes a regulated system, subject to PLM qa automation validation under GAMP 5 Category D.
Of the six tools evaluated, Sahi Pro satisfies this requirement through its structured execution records with per-step timestamps, combined with full on-premise deployment that keeps all data within the company network. Worksoft Certify and Tricentis Tosca both offer on-premise deployment and can produce execution logs, though their 21 CFR Part 11 record formatting may require additional configuration or third-party documentation layers. OpenText UFT One supports on-premise deployment but does not produce 21 CFR Part 11-specific record formats natively. Tricentis qTest provides compliance-ready documentation at the test management layer but depends on a separate automation tool for execution. Leapwork’s cloud-primary architecture creates a data residency concern for pharma teams, as SAP quality workflow data may route through external infrastructure.
For compliance-specific tool selection, request documentation from each vendor on whether their deployment model satisfies 21 CFR Part 11 Subpart C, ISO 13485:2016, and GAMP 5 Category D data residency requirements. Cloud-only vendors typically cannot provide this.
Real Results: ArisGlobal
ArisGlobal is a global provider of R&D software solutions and consultancy services dedicated to serving life sciences companies in the management of clinical trial, safety, and regulatory information. They started test automation with a leading commercial tool but moved away due to limitations: no record and playback, no relative APIs, and mandatory object repository maintenance that consumed significant effort. Complex conditional automation could not be handled by the tool they were using.
ArisGlobal moved to Sahi Pro to solve these specific problems, taking advantage of the SAP add-on for quality workflow automation and the ability to deploy on-premise for data residency compliance.
The results after implementation:
- 70% reduction in time for multiple regulatory report generation for one of the life sciences products.
- Data-driven tests reduced testing cycles across multiple regulatory test data sets, improving coverage.
- Non-technical regulatory team members able to participate in automation without specialist skills.
- Positional Relation APIs automated controls without specific unique identifiers in complex SAP quality UI.
Our verdict: the best SAP PLM test automation tool for pharma, biotech, and medical device teams
For life sciences teams that need to automate SAP GUI quality management transactions, produce 21 CFR Part 11 compliant records, and deploy fully on-premise, Sahi Pro is the strongest fit. Its SAP add-on addresses the specific technical gap that web-only tools cannot fill. Teams already invested in Tosca for SAP ERP testing or Worksoft Certify for no-code SAP automation have valid reasons to stay with those tools, particularly if their scope does not extend beyond SAP GUI transactions into cross-layer Fiori workflows.
Sahi Pro offers a free trial. You can test it against your own SAP PLM with SAP GUI and Fiori environment before any license decision.
If you want to see how Sahi Pro handles your most complex SAP PLM quality workflow, bring your hardest test scenario. The team will run it with you. Book A Demo.
