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Life science / pharma DTC

The patient-access pattern, built and proven.

Independent telehealth intake, benefit verification, and a cash-pay pharmacy or fulfillment layer: the shape of LillyDirect, PfizerForAll, and NovoCare Pharmacy. Reference programs, cited for the pattern they show, not as Softwerk clients.

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What this market has to prove.

01

Computer-system validation means evidencing, in writing, exactly how a system was built and that nothing was altered afterward. Every release, kept forever.

02

Manufacturer DTC programs route through a stack of partners: an independent telehealth network, a benefit-verification layer, a dispensing pharmacy. None of the manufacturers researched builds that whole stack itself. The identity, consent, and evidence layer between the partners is what is left to build.

03

On 2024-10-22 four senators wrote to Pfizer and Eli Lilly with 13 questions about their telehealth arrangements and published an investigative report on 2025-07-17. On 2025-09-09 FDA sent roughly 100 cease-and-desist letters over DTC drug advertising. Clinician independence and disclosure now have to be shown, not stated.

What a life-science discovery sprint looks like

A sample scope, written the way an engagement is written. It is what Softwerk sells, not a case study of a past build.

What you bring
One partner interface: a benefit-verification API sandbox, a telehealth partner's referral hand-off format, or a dispensing pharmacy's order format. De-identified sample records. The hub-services workflow as it is documented today.
The one surface
The patient identity and consent record that sits between the telehealth partner and the pharmacy, with an audit trail of every access to it.
What you leave with
A running integration against the sandbox. A fixed-price build proposal with acceptance criteria. A certificate for every build produced in the sprint: sha256 of the tree, the commit it was minted for, and the HIPAA verdict. Your validation team can inspect each certificate in the factory during the sprint.
Out of scope
GxP or 21 CFR Part 11 validation sign-off: there is no such profile in the gate, and it is not live. Promotional claims and MLR review. Production PHI.
Terms
Fixed length and fixed price, agreed in writing before it starts.

The regime, live and not live.

Every framework below is labelled with whether it runs in the gate today. Nothing is described as live unless a checklist is live.

What the gate does, and what it does not.

There is no GxP or 21 CFR Part 11 profile in the gate, and this page says so rather than imply one. The write-once, content-addressed certificate is what the factory offers a validation team: a sha256 of the exact source tree on every release we build for you, with the verdict recorded once. The review behind it is independent by construction: the reviewer is pinned to a distinct model family, and a same-family review is refused rather than allowed through.

How the engagement runs.

Four stages, one gate on every change. Priced and agreed before work starts.

  1. 1

    Discovery sprint

    Fixed length, fixed price, against one real partner interface, on de-identified data.

  2. 2

    Fixed-scope build

    The factory builds the patient-facing and hub-services surface with the HIPAA profile loaded from the first task.

  3. 3

    Verification gate

    We run your workspace with the gate enforced. Every diff gets an independent-model review, your compliance profile runs on the output, and a merge needs a valid certificate for that exact tree.

  4. 4

    Operate

    The write-once certificate accumulates as validation evidence, release over release, and the scope names what a human reviews and when.

Asked before every first call.

What about FDA rules on DTC drug advertising?

The gate does not run an FDA promotional-review profile, and we do not claim it does. On 2025-09-09 FDA and HHS sent roughly 100 cease-and-desist letters over DTC drug advertising and warning letters to about 30 telehealth companies, and FDA has proposed removing the “adequate provision” option for broadcast ads. What we build is the infrastructure that makes your MLR or legal review fast to do and easy to prove: versioned content, an audit trail of what shipped when, and a review step your team sits inside. The promotional judgment stays with you.

Do you validate to GxP or 21 CFR Part 11?

Not as a coded profile in the gate. It is flagged not live wherever it appears. What the engagement gives you instead: a write-once, content-addressed certificate, a sha256 of the exact source tree, for every build. FDA's Computer Software Assurance guidance (2025-09-24) favors risk-proportionate evidence, and the certificate is usable evidence in that framing. It is not a substitute for a GxP checklist, and we do not sell it as one.

Who owns the code, and who is responsible if AI-generated code is wrong?

You own the delivered work product under the engagement terms. A certificate carries the sha256 of the exact source tree, the commit it was minted for, and the compliance verdict. The certificate does not record which model reviewed the build. Independence is enforced where the review runs: a review from the same model family that generated the work is refused. It is a build attestation of the kind buyers now ask for alongside a Software Bill of Materials; the factory does not produce an SBOM. On responsibility: model vendors disclaim broadly in their terms of service, Softwerk is responsible for delivering to the agreed acceptance criteria, and operating what we build is yours, as in any services engagement.

Is the gate switched on for our project, or is it a setting?

It is a setting, and the engagement scope names it. The verification gate, the compliance veto, and the PHI guard each carry their own enforcement flag in the factory, and each is off until an operator turns it on. Off, the checks still run and their findings are still recorded, but nothing is withheld. On, they refuse the merge or the write, and the safe state is stop. We turn all three on for the workspace that builds your software, we put that in writing in the scope, and you can ask to see the setting on your workspace at any point in the engagement.

Full FAQ →

A goal goes in. Provable software comes out.

Bring the goal and the compliance regime. The engagement brings the spec, the build, the independent review, and the certificate.

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