Computer system validation talent for GxP teams
People who keep regulated systems in a validated state.
ValNexus LLC is a human resource company built around computer system validation. We connect life sciences and other GxP-regulated teams with CSV, infrastructure qualification and data integrity specialists, whether you need help with one change request or a full validation lifecycle.
New requestsinfo@valnexuss.com
Supportsupport@valnexuss.com
Hover a step to see what it delivers.
Validation is a people problem before it's a document problem.
Protocols, traceability matrices and reports only stand up when the person who wrote them understands the system underneath. ValNexus finds and places specialists who do, across applications, infrastructure and the vendors in between.
Need one engineer to review a change request, or a team to validate a cloud migration? We match on the system and the type of work, not just the job title.
End-to-end validation, one verified step at a time.
Most engagements plug into one or more points on this chain, from the first risk assessment to retirement. Scroll to follow a system through its whole life.
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1
Initial risk assessment
Before anything is written, assess the system as a whole: intended use, GxP impact, data criticality and regulatory exposure. The result sets how much validation the system needs.
Deliverable: initial system risk assessment -
2
Validation plan
Define scope, strategy, roles, deliverables and acceptance criteria, driven by the initial risk assessment.
Deliverable: validation plan -
3
URS
What the business and the regulators need the system to do, written so every line can be tested.
Deliverable: user requirements specification -
4
Risk assessment
Go a level deeper: assess risk for each requirement and function, so test depth follows GxP impact and protects patients and data.
Deliverable: risk assessment -
5
FS / DS
Translate requirements into how the system will function and how it will be built or configured.
Deliverable: functional and design specifications -
6
Configuration / development
Configure the product or build the code under change control, so every setting can be explained later.
Deliverable: configuration specification or build record -
7
Testing
Execute scripted tests and capture objective evidence that each requirement is met.
Deliverable: executed protocols and test scripts -
8
UAT
The people who will use the system confirm it fits the way they actually work.
Deliverable: signed UAT results -
9
Validation summary / report
Close the loop: trace requirements to evidence, list deviations and conclude whether the system is fit for use.
Deliverable: validation summary report -
10
Release
Approved for GxP use, with procedures, training and support in place.
Deliverable: release approval -
11
Change requests for maintenance
Once the system is live, every maintenance change goes through change control: assess validation impact and risk, agree the testing needed, then implement and re-verify.
Deliverable: change request with impact assessment and test evidence -
12
Retirement
At end of life, execute the retirement plan: data retention and archiving, migration verification and validation closure.
Deliverable: retirement report and validation closure
Twelve kinds of validation work we staff.
Open any work type to see what your specialist will actually be doing.
Which GAMP category is your system?
The category follows how the system is configured and used, not the product name. Move along the scale to see typical examples and the validation work each category calls for.
GAMP 5 categorization is based on the specific system, its configuration and its intended use. The examples above are typical starting points, not automatic classifications; the final category comes from your risk assessment.
The systems and work our specialists cover.
Browse by technology to see the typical GAMP category and hosting model, or by work type to see the applications and infrastructure it applies to.
| Area | Examples | Typical GAMP | Hosting |
|---|
| Work type | Application examples | Infrastructure examples |
|---|
Who owns what: SaaS or on-premise.
Where a system is hosted changes what you validate yourself and what you assess in the vendor. Switch the view to compare.
The specialists we place.
From hands-on test execution to leading a validation plan, these are the roles our clients ask for most.
Flexible ways to engage.
- ContractA specialist for the length of a project, change or remediation.
- Contract-to-hireWork together first, then decide on a permanent role.
- Direct placementA permanent hire for a validation or compliance role.
- Project teamSeveral specialists matched to a larger validation effort.
From first email to first day.
A short path from your brief to a specialist who is ready to work.
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1
Send the brief
Tell us the system, the work type and the timeline. Email info@valnexuss.com or use the form below.
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2
We match
We shortlist specialists by system, GAMP category, hosting model and type of validation work.
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3
You confirm
You review profiles, talk to the people you like and choose how to engage them.
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4
We stay in touch
Questions during the engagement go to support@valnexuss.com.
Tell us what needs validating.
Send a request and the right person will pick it up. New requests go to our info inbox; anything about an existing engagement goes to support.
Send a request
Your request is ready.
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