Chicken or Egg: What Comes First, the System or the Documents?

Everything a biotech tells a health authority is authored, and accurate authoring needs an official record of truth. So which comes first, the system or the documents? Here is why neither order works, what the process should look like, and how it will change our jobs.

When you work with a health authority, at the core you are doing four things. You describe what the drug does. You show how you tested it in people, from the first clinical trial through the studies that proved it is safe and that it works. You show that your manufacturing steps meet the quality standards that are mandated. And then there are the yearly administrative tasks that keep all of it current.

Every one of those is authoring. That makes the documents the most important assets a biotech has.

For years we had medical writers doing that work. Now there is AI, and we are not sure what AI will do to that. But whether it is AI or a medical writer, the writer can only be as accurate as what they are writing from. To author accurate information you need a system, an official record of truth.

That raises a chicken-or-egg question. What comes first, the system or the documents?

Most companies say the system, and then the handoff happens

Most companies answer by building the system first. A lot of money gets spent on a GxP system. It gets validated, people get trained, and on paper everything is controlled.

That holds as long as the work stays inside the company. It rarely does. The medical writing agency writes the study report. The ad agency builds the promotional material. The CDMO holds the specifications and the batch data. The minute a handoff needs to occur, the process gets complicated.

The reason is simple. The partner is not in your system, and getting them in is clicky and cumbersome. So people do what works. E-mails and spreadsheets rule.

People do what works. E-mails and spreadsheets rule.

In practice, then, the documents come first after all. They get written, reviewed and argued over in inboxes, and the system receives the final file at the end.

Everybody knows the gap is there, so additional QC gets built around it. Someone checks the number in the summary against the number in the report. Someone checks that the specification in the filing is the one the manufacturer is actually using. That is a second layer of work that exists only because the work left the system.

The answer is that they cannot be separate

So the system-first answer fails at the handoff, and the documents-first reality costs you a layer of QC. Neither order works, and we think that is because the question treats the system and the documents as two things.

What actually comes first is the information: the specification, the study result, the approved claim. A document is that information written up for one purpose. The system should be where that information lives from the day it is created, including when the work crosses to a partner.

That last part is the condition. The system has to be easier than e-mail at the handoff, because that is exactly where people leave it.

What the process should look like

Once you see it that way, the ideal process follows from keeping the handoff simple.

The information lives in one place. A specification exists once, with an owner, and every document that uses it points to it. The same number shows up in five documents because it is the same number, not because someone typed it five times.

The partners work in that same place. The agency and the CDMO get access to what they need, so the handoff becomes a change in access and not a file sent by e-mail. Review happens there too, so comments and approvals stay with the content.

And the checking is built in. Any statement can be traced back to where it came from, and when something changes you can see every document it affects. The QC that was built around the gap is no longer needed, because the gap is closed.

This is also where the AI question from the start gets answered. If AI writes from scattered e-mails, you get a document that reads well and is wrong. If it writes from the official record, a qualified person can check it quickly. Whether it is AI or a medical writer matters less than what they are writing from.

That is how we think about it at DnXT. Authoring, review, publishing and submission belong in one platform, and the people you work with should be able to work in it with you.

What this does to biotech, and to our jobs

When the information lives in one place and the first draft is the easy part, a biotech looks different. A young company will be able to do with a few people what used to take a department and several vendors. The work that is left is deciding what to say and knowing whether it is right.

That changes job responsibilities, and it tells you what to learn.

Medical writers will spend less time drafting and more time deciding what the document needs to say and whether the draft holds up. The skill to build is checking: tracing a statement back to its source quickly and catching the one that does not hold.

Regulatory operations will spend less time formatting and assembling and more time making sure the underlying information is right and current. The skill to build is knowing where every piece of information comes from and who owns it.

Quality will spend less time comparing documents by hand and more time on the exceptions. The skill to build is understanding the whole process, especially the handoffs, because that is where the exceptions come from.

Agencies and CDMOs will be expected to work in the sponsor’s system, not around it. The ones who learn to do that well will be easier to choose.

For everyone, two things apply. Keep building regulatory judgment, because knowing what an agency will ask, and why, is not going away. And start using AI now. Draft something real with it and check every line. You will see quickly where it helps and where it does not.

Back to the question

So, chicken or egg? The companies that keep building the system first and e-mailing the documents around it will keep paying for the gap. The ones that put the information first, in one place where their partners also work, will not have to choose.