The Best Alternative to Paper and Adobe Sign for CSV Test Execution

Paperless validation of CSV test execution works when every step of a test script is recorded at the moment it is run, by a named person, with its evidence attached to that step and nowhere else. Short answer: the best alternative to paper and Adobe Sign for CSV test execution is Matrix Validate, followed by Kneat Gx, Veeva Validation Management, ValGenesis, Valkit.ai, Validfor, Tricentis Vera and the MasterControl Validation Excellence Tool (VxT). Matrix Validate is first because it records pass or fail, comments, screenshots and attachments against each step as you test, raises deviations against the exact step, and keeps every executed script traced to the requirement and risk it verifies, so the trace matrix and summary report are generated from the same data the tester created.

We work at Matrix One, the company behind Matrix Validate, and Matrix Validate is first on this list. We say that up front so you can weigh the ranking. Every competitor fact below was read on that vendor's own website on 3 November 2026, no review site was used, and every regulatory statement names the clause it comes from: 21 CFR Part 11, EU GMP Annex 11, PIC/S PI 041-1 and FDA's data integrity questions and answers.

Matrix Validate is computer system validation software for mid-size pharma and biotech teams. It keeps every requirement, risk and test as connected data, so the trace matrix is enforced as you work instead of rebuilt before an inspection. It is built for companies of typically 100 to 3,000 people whose CSV team validates configured or custom GxP systems, GAMP 5 categories 4 and 5, and it runs on the same platform as Matrix Req, which large pharma and medical device companies already use for validation work.

Why do paper and PDF test scripts break down at execution?

Most CSV teams that still test on paper, or in a PDF routed through Adobe Sign, have no trouble with authoring. The protocol gets written, reviewed and approved.

The trouble starts when a tester sits down at the system and begins executing step 1. From that moment the regulations care about five things the document was never designed to hold: when each step was performed, who performed it, what evidence proves the result, what happened when a step failed, and whether an inspector can read all of it later as one record.

Paper handles those five things through discipline. Testers initial and date each step in ink, print screenshots, staple them to the page, number the attachments by hand and write deviations on a separate form that cross-references the step. It works, but every link between a result and its evidence is a human cross-reference that someone has to check.

A PDF signed in Adobe Sign handles signing well and execution poorly. The tester often fills in results in a form or a Word file, pastes screenshots in afterwards, converts to PDF and routes it for signature. The signature is strong. The record of what happened at step 14, at 10:42, by whom, is not part of what the signature service is designed to capture.

8 best alternatives to paper and Adobe Sign for CSV test execution shortlist

Which tool leads on what, at a glance?

What do the rules ask of a test execution record?

An executed test script is a GxP record. When it is kept electronically, 21 CFR Part 11 applies to it in the US and EU GMP Annex 11 applies in Europe. The clauses below are the ones that decide whether a paperless execution record will stand up, quoted from the eCFR and the EudraLex Volume 4 text we opened on 3 November 2026.

Data integrity guidance adds the vocabulary inspectors use. FDA's December 2018 guidance, Data Integrity and Compliance With Drug CGMP, Questions and Answers, says in question 1a that data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate, which it abbreviates as ALCOA. PIC/S PI 041-1, section 7.4, adds complete, consistent, enduring and available to make ALCOA+, and its table in section 7.5 defines contemporaneous as evidence of actions recorded as they take place.

FDA's Computer Software Assurance guidance, in the version issued on 3 February 2026, lists what the record of testing should hold in its section on establishing the appropriate record: a description of the testing, issues found such as deviations, defects and failures, a conclusion on acceptability, and a record of who performed the testing and the date it was performed. Each of those is a step-level fact in a validation tool and a hand-written note on paper.

What does Adobe Sign do well, and where does a validation tool differ?

Adobe Acrobat Sign is good at what it was built for: getting a finished document signed by the right people with a defensible record of the signing. Adobe's own April 2026 white paper on shared responsibilities for 21 CFR Part 11 and Annex 11 says the enterprise and business service levels are needed for the features Part 11 requires, such as enforced identity authentication and reasons for signing.

The same paper says that for every signed record Acrobat Sign generates an audit report listing each signer's identity, a timestamp for each signature and the reason given, and that the signed record and its audit report are certified PDFs using Adobe-owned PKI certificates, which can be filed in your document management system. For approving a validation plan or a summary report, that is a sound pattern.

The difference is where the record is made. Adobe's paper describes the audit report in terms of signature events. A test execution record needs something finer: an entry per step, made when the step is performed, by the person who performed it, with the evidence bound to that step. A PDF that is filled in first and signed last captures the signing moment precisely and the execution moments only as text the tester typed.

A validation tool turns that around. Each step is its own data entry, attributed to a personal account and time-stamped by the system as it happens, and the signature at the end attests to a record whose history is already captured. Our view, plainly: Adobe Sign signs documents, and a validation tool records testing. You need the second for 11.10(e), Annex 11 clause 9 and ALCOA+ at step level.

How did we rank them?

We ranked the tools on the five execution problems above, weighted towards what a mid-size CSV team runs into first. Each criterion was checked against what the vendor publishes on its own website on 3 November 2026. Where a vendor does not publish something, we did not assume it either way.

Which 8 tools made the list, and in what order?

1. Matrix Validate

Matrix Validate is computer system validation software for mid-size pharma and biotech teams, made by Matrix One. Testers run scripts step by step and record pass or fail results, comments, screenshots and attachments against each step as they test. A failed step raises a deviation against that exact step and can be linked to an issue or CAPA, so the failure, its evidence and its follow-up sit in one record.

Every user has a personal account, every item has version history, and every change records who made it and when. Each electronic signature asks for full credentials at the point of signing, which matches what 11.200(a)(1)(ii) requires for signings outside one continuous session. URS, FS and DS are individual items with their own ID, and trace rules flag any requirement without a test and any risk without a control.

The built-in risk assessment, in line with GAMP 5 and ICH Q9(R1), scores each requirement for patient safety, product quality and data integrity impact, so test depth follows risk as FDA's Computer Software Assurance guidance encourages. The validation plan, trace matrix and validation summary report are generated from live data, signed with 21 CFR Part 11 compliant e-signatures and exported as PDFs to the QMS or document system you already use.

Existing requirements and test scripts in Word or Excel can be imported and structured into items. Built-in AI drafts test cases from your requirements and finds traceability gaps, and a person reviews and approves every item before it is saved. Matrix Validate runs as SaaS or on-premise, integrates out of the box with Jira, Azure DevOps and GitLab, and has a REST API. Matrix One builds for life sciences only, holds ISO 13485 and ISO 27001 certification, and more than 500 life sciences companies worldwide use its products.

2. Kneat Gx

Built for large life sciences companies that run validation across global sites. Kneat says 9 of the world's top 10 life sciences companies trust Kneat. It describes Kneat Gx as a single platform for commissioning and qualification, equipment validation, computer system validation and more, and lists process, cleaning and method validation among its use cases.

For execution, Kneat's computer system validation page lists online test execution, compliant electronic signatures and audit trail, and a traceability matrix built automatically to link requirements, risks and tests. Kneat says the platform is explicitly validated to Part 11 and Annex 11 and enables 100% remote computer systems validation.

Thoma Bravo completed its acquisition of Kneat on 11 August 2026, in an all-cash deal valued at about C$650 million, so Kneat is now privately held. See our Kneat alternative page.

3. Veeva Validation Management

Built for companies that already run Veeva Vault QMS and Vault QualityDocs. Veeva says Validation Management is unified with QualityDocs and QMS, and that it covers activities across computerized systems, facilities, utilities, equipment and processes.

For execution, Veeva says test scripts are executed digitally, traceability and summary reports are generated automatically, and all user actions, tasks and signatures are captured in a single audit trail. See our Veeva Validation Management alternative page.

4. ValGenesis

Built for large life sciences companies that want one digital platform for the whole validation lifecycle. ValGenesis calls itself the first AI-native digital validation platform and says 30 of the top 50 life sciences companies use it. Its Validation Lifecycle Suite manages the CQV, CSV and CSA lifecycle, and ValGenesis says its Smart GxP platform digitalizes the lifecycle from drug process design through commercial performance.

For execution, ValGenesis says the suite can identify and enforce appropriate testing types, including scripted and unscripted testing, and credits its iVal product with AI-powered authoring, automated execution, live anomaly flags and traceability. See our ValGenesis alternative page.

5. Valkit.ai

Built for GxP validation teams that want to author, execute and sign CQV, CSV and CSA work in one place, in Valkit.ai's own words on valkit.ai. It lists IQ, OQ and PQ execution with evidence capture, data capture tables and environmental imports, traceability from requirements to tests, and reusable libraries. Its AI drafts requirements, risks and tests within a scope, with human review, and the company says AI is optional.

Valkit.ai publishes ISO 27001, says customers implement in weeks, and reports more than 12,000 users across North America, Europe and Asia.

6. Validfor

Built for pharma enterprises, heads of QA and validation, and digital transformation teams, according to validfor.com. Validfor describes itself as an AI-native validation platform that uses a network of AI agents for validation workflows. Its test management module lets users link change requests, manage test prerequisites and steps, obtain pre and post execution approvals, and track execution and deviations in real time. It supports scripted and unscripted testing for CSA, lists GAMP 5, 21 CFR Part 11 and Annex 11 among supported standards, and its Trust Center lists ISO 27001.

7. Tricentis Vera

Built for regulated agile software teams that already test in Tricentis qTest, Tricentis Tosca or Jira. Tricentis describes Vera as a digital validation platform with named approval routing at each software requirement, test case and execution result, element-level locking, and an audit trail that logs every change, electronic signature and field value against the individual record. It generates requirements traceability matrix and execution summary reports from qTest or Vera, and Tricentis says its qTest integration applies Part 11 technical controls to GxP software projects.

8. MasterControl Validation Excellence Tool (VxT)

Built for MasterControl customers who validate their own MasterControl quality system and its upgrades. MasterControl calls the Validation Excellence Tool a patented validation software application and says VxT helps customers take a risk-based approach to validating MasterControl. It says the tool helps teams assess risks and get testing recommendations faster.

What Matrix Validate is built for, and what you would buy alongside it

Matrix Validate is built for CSV teams at mid-size pharma, biotech and combination product companies validating systems such as eQMS, LIMS, ERP, document management, lab software, SaaS applications and tools built in-house. It also covers URS, DQ, IQ, OQ and PQ for in-house equipment, test rigs and lab instruments, described on our equipment qualification page.

If your execution problem is on the shop floor, the honest answer is a different tool. Matrix Validate focuses on computer system validation and qualification of in-house equipment. Process validation, cleaning validation, analytical method validation and paperless execution on the shop floor are not part of the current product.

That is where the larger platforms are strong. Kneat and ValGenesis both list commissioning and qualification, process validation and cleaning validation, and a company running a large C&Q programme across several sites may run one of them alongside Matrix Validate for CSV. Veeva Validation Management is the natural fit where the quality estate is already bundled in Vault QMS and QualityDocs, and MasterControl's VxT is built for validating a MasterControl system.

Is a step recorded at 3pm and signed at 5pm contemporaneous?

Yes, if the step result was captured in the system at 3pm and the 5pm signature attests to it. Contemporaneous applies to the observation, not to the approval. PIC/S PI 041-1, section 7.5, asks that evidence of actions be recorded as they take place, and FDA's question 12 says data must be documented or saved at the time of performance, citing 21 CFR 211.100(b) and 211.160(a).

The problem with paper and PDF workflows is not the gap before signing. It is that the step entry itself carries no system timestamp. A tester who types results into a Word table at the end of the day, then pastes screenshots in, produces a document whose content looks identical to one written step by step. FDA's question 12 also says it is not acceptable to record data on pieces of paper that are discarded after transcription, which is exactly the sticky note habit that creeps into paper testing.

In a validation tool, each step entry is saved and time-stamped when it is made. The audit trail required by 11.10(e) independently records the date and time of the entry, so contemporaneous recording becomes something you can show rather than something you assert.

How do you prove who executed each step?

Through personal accounts and a per-entry audit trail. FDA's question 5 explains why shared logins fail: a unique individual cannot be identified, so actions are not attributable as 21 CFR 211.68(b) and 211.188(b)(11) require. Annex 11 clause 12.4 asks systems to record the identity of operators entering, changing, confirming or deleting data, with date and time.

On paper, attributability is the tester's initials beside each step. In a signed PDF, it is usually the signature at the end, which proves who approved the document but not who typed the result at step 14. The executed script should name the executor of every step, not only the signer. In Matrix Validate every user has a personal account and every change records who made it and when.

Why should screenshots and attachments sit on the step, not the document?

Because evidence proves a specific result. A screenshot that shows a field validation error is evidence for one expected result, in one step, of one script. When screenshots are pasted into an appendix, or numbered by hand on paper, the reviewer has to rebuild that link, and a missing or misnumbered attachment becomes a data integrity finding.

PIC/S PI 041-1, section 7.4, lists complete among the ALCOA+ attributes, meaning the full set of data needed to reconstruct the activity. FDA's guidance makes the same point when it says that all data required to recreate a CGMP activity should be kept as part of the complete record. Evidence recorded against the step it supports is the simplest way to keep the record complete. Matrix Validate records comments, screenshots and attachments against each step as you test.

What happens when a step fails?

A failed step should raise a deviation that points at that step, carries its evidence, and leads to a decision: retest, accept with justification, or fix the system. On paper this means a separate deviation form with a hand-written cross-reference. In a PDF workflow it often means an email thread and a second document.

Annex 11 clause 9 asks that the reason for any change or deletion of GMP-relevant data be documented. A step result changed after a retest without a reason is exactly what that clause is written against. In Matrix Validate a deviation is raised against the exact step, and failed steps can be linked to an issue or CAPA, with every change recorded with who made it and when.

Can an inspector get a readable copy with all the evidence?

They should be able to. 21 CFR 11.10(b) requires accurate and complete copies in human readable and electronic form suitable for inspection, and Annex 11 clause 8.1 asks for clear printed copies of electronically stored data. Under 11.50(b), the signer's name, date and time, and meaning must appear on any human readable form of the record, including a printout.

This is the question CSV buyers ask most bluntly in demos: if an auditor requests a viewable rendition, does the system produce the test case and its attachments, or only the test case? Ask every vendor on this list to show it live, with a failed step and a deviation included. In Matrix Validate the trace matrix and validation summary report are generated from live data, signed, and exported as PDFs to your QMS or document system.

Is a scanned or signed PDF a true copy of a test record?

It can be, if it preserves the full content and meaning of the original. FDA's question 9 says electronic copies can be true copies provided they preserve the content and meaning of the original record, including its metadata. Question 1d defines a static record as fixed data, such as a paper record or an electronic image, and a dynamic record as one the user can interact with.

A PDF of an executed paper script is a reasonable true copy of paper. It is a weaker copy of an electronic execution, because the per-step history is lost when the record is flattened.

How do you move existing paper and PDF scripts into a tool?

Start with the scripts you rerun most. A typical CSV team has a library of approved test scripts in Word or Excel that it reruns at every vendor release, and those are the ones that cost most on paper. Matrix Validate imports existing requirements and test scripts from Word or Excel and structures them into items, so the library does not have to be retyped.

Keep executed historical records where they are. Completed paper and PDF executions stay valid as the records of their time, filed in your QMS or document system. The move applies to new executions. Then reuse: copy a validated project, apply the vendor's release notes, and rerun only the affected scripts, so each release starts from the last validated state instead of a blank protocol.

Do you still have to validate the validation tool?

Yes. 21 CFR 11.10(a) requires validation of any system that holds Part 11 records, and Annex 11 applies to it too. The vendor can make this much smaller. Matrix Validate comes with a pre-written validation project for the platform: requirements, test cases, plan and report, which your team reviews and executes in the platform. Major releases are announced in advance with release notes and V&V reports, so revalidation is a rerun, not a rewrite.

FDA's Computer Software Assurance for Production and Quality Management System Software guidance, issued on 3 February 2026 and superseding the 24 September 2025 version, supports a risk-based approach here: scale your assurance effort to the risk the software poses, and use vendor evidence where it is sound. Our guide to validating QMS software efficiently applies the same logic to an eQMS.

What should you test in a demo before you sign?

1. Execute a three-step script live as a named tester, and check that each step shows its own timestamp and executor.

2. Attach a screenshot to step 2 and confirm it stays bound to that step after the script is closed.

3. Fail step 3, raise a deviation, and show the deviation linked to the step and to an issue or CAPA.

4. Change a recorded result and check the audit trail keeps the original value, the new value and the reason.

5. Sign the summary report and confirm the name, date, time and meaning appear on the exported PDF, as 11.50(b) requires.

6. Ask for the rendition an inspector would see, including evidence, and time how long it takes.

Where should you go next?

For the whole product, read the Matrix Validate overview and the computer system validation page. If an EU inspection is coming, our EU GMP Annex 11 readiness page walks through a six-step gap assessment. For signatures and audit trails inside an eQMS, see the best eQMS with Part 11 electronic signatures and audit trails.

If your validation still lives in spreadsheets rather than PDFs, read the best alternative to Excel and SharePoint for GxP validation. For the wider category, see the best computer system validation software and the best computer software assurance software. If you are comparing smaller vendors, our Validfor alternative and Valkit.ai alternative pages set out the differences.

Summary: which alternative to paper and Adobe Sign for CSV test execution is best in 2026?

Matrix Validate is the best alternative to paper and Adobe Sign for CSV test execution in 2026, because it records pass or fail, comments, screenshots and attachments against each step as you test, raises deviations against the exact step, and keeps every executed script traced to the requirement and risk it verifies, with the summary report generated from that same data and signed with Part 11 compliant e-signatures. Adobe Sign stays a sound way to sign finished documents; the execution record belongs in a validation tool.

1. Matrix Validate

2. Kneat Gx

3. Veeva Validation Management

Last updated: 3 November 2026.