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Assurance that protects patients, not paperwork.
Attestra is a consulting practice focused on computerized-system assurance for life sciences: Computer Software Assurance, data integrity, and AI in regulated work. We also build software on the same assurance lifecycle our consultants use.
Why we exist
Life sciences companies spend enormous effort proving their systems work, and much of that effort doesn't make anyone safer.
Traditional validation often documents low-risk functions as heavily as critical ones. The result is stacks of scripted evidence that are rarely read again, while the real risks to data integrity and product quality can go unexamined.
Regulators have said for years that assurance should be risk-based. Even so, many organizations still work the old way, because changing procedures, habits and culture is hard.
At the same time, AI is arriving in regulated work faster than most quality organizations can assess it. Some teams avoid useful tools out of uncertainty. Others adopt them without the controls they need. Neither outcome serves patients.
Attestra exists to close that gap. We help companies put assurance effort where it actually protects patients and data, and adopt new technology, AI included, with confidence instead of fear or shortcuts.
Our mission
To help life sciences companies show that their computerized systems, including AI, are fit for intended use, with assurance effort proportional to risk to patient safety, product quality and data integrity.
Our vision
A regulated industry where assurance effort goes where it protects patients and data, and where teams can adopt new technology, including AI, with confidence instead of hesitation.
What we believe
Use before product
We classify risk by how a system is used, not by what it's called. The same software can carry very different risk in two different processes.
Rigor where it matters
We test critical functions thoroughly and lighten the rest. Computer Software Assurance doesn't mean less testing. It means testing in the right places.
Defensible by design
Every decision we make, and every decision we help you make, can be explained to an inspector.
Capability that stays
We work alongside your QA and IT teams and leave behind procedures and skills they can run without us.
How we work
Every engagement is anchored in one assurance lifecycle: intended use, risk assessment, supplier assessment, assurance planning, assurance activities, reporting and release, then ongoing monitoring, change control and periodic review. That keeps our work consistent whether we're assessing a single system change, building a CSA program from scratch, modernizing CSV procedures, or bringing an AI tool into regulated use.
We're practitioners. We deliver what your teams will actually use, written in plain language and sized to the risk.
Our approachWho we work with
QA, IT and validation teams in pharmaceutical, biopharmaceutical, personal care and other regulated life sciences organizations, from companies building their first assurance program to established quality organizations moving from CSV to CSA or adopting AI.
Who we serveOur principal consultant
Humphrey N. Awinyo, MBA
Principal Consultant
Humphrey brings 15+ years of experience in GxP IT quality and computerized-system validation across the pharmaceutical, biopharmaceutical and personal care industries. His work has included QMS, document management and enterprise system implementations, data integrity, and moving organizations toward risk-based assurance.
He holds an MBA in Management Information Systems from the New Jersey Institute of Technology and a B.S. in Biology from New Jersey City University, and is trained in Lean. He writes about practical, risk-based assurance, including the Use → Risk → Rigor approach to classifying computerized systems.
Valoryn
Alongside our consulting work, we're building Valoryn, software based on the same assurance lifecycle, to support risk-based planning, traceability and reporting for conventional and AI-enabled systems.
Valoryn is in development and testing and is not yet commercially available.
Attestra LLC is based in New Jersey.
Let's talk
Tell us about a new CSA program, a system change, a CSV-to-CSA transition or an AI initiative.