Signature Bloat: How Too Many Approvals Slow Down Your Releases, and How to Solve It

You finished the SDLC plan three weeks ago. It's good. It's done. And it's still not released?

Here's why. The routing needed nine signatures! Engineering, QA, Regulatory, Information Security, DevOps, Validation, Product, Project Management, and the CTO. Every one of them has to open the same forty-page document and put their name on the whole thing. The security lead cares about one section, secure coding and access control. The validation lead cares about the test strategy. Neither of them cares much about the other seven sections, but they're on the hook for all of it, so they read all of it, slowly, in between everything else on their plate.

Then… it stalls. One approver is out for the week. Another has a question about the configuration management section, which isn't even their area, and their comment freezes the entire document while everyone waits for it to get sorted. The plan bounces back to the author. A round of edits, a new version, and now all nine people have to sign again. Three weeks in, and the release that depends on this plan is still waiting.

If you work in a regulated shop, you know this movie and you've probably starred in it. The frustrating part is that most people assume this is just what compliance costs. But it isn't, and the regulations never asked for any of this.

Where the signature pile-up comes from

Somewhere along the way, "the document needs to be reviewed and approved" quietly became "everyone who touches the process needs to sign the whole document." Those are not the same thing, and the second one is where release timelines go to die.

Think about what actually happens when you put nine names on a single approval. You've built a chain where the slowest person sets the pace. You've given eight people the ability to block a document over a section that isn't theirs. And you've guaranteed that the next time you update one paragraph, you get to route the entire thing past all nine again. More approvers doesn't mean more control. It means more places for the document to get stuck, and a smaller and smaller chance that the person signing section 6 actually knows enough about section 6 to catch a problem in it.

That last point matters more than it looks. When a Regulatory lead signs off on a deep technical section on branching strategy, what are they really approving? In most cases, they're trusting that whoever wrote it knew what they were doing. The signature looks like a control. It's mostly a formality wearing a control's clothes.

And then the review cycles start

The one-signature-per-person problem is just the opening act. The real time sink is what happens across review cycles.

Hand someone a forty-page document and they don't stay in their own section. They comment on all of it. DevOps has thoughts on the wording in the regulatory section. Regulatory has thoughts on the test approach. None of it is their call and most of it isn't their expertise, but the document is open in front of them and the comment box is right there, so the opinions come.

The author works through the comments, makes the edits, and sends it around again. Now people are reviewing the changes other departments asked for, and disagreeing with them. Still outside their lane. Still not the decision-making party. A section that was settled two weeks ago gets reopened because someone two teams over doesn't like how the fix reads.

And since the document was too long to read closely the first time, the second pass turns up a fresh batch of comments on things people simply missed at the start. So the second cycle produces a third. Every round seeds the next one, and the document never quite lands.

There's a quieter dynamic under all of this too, and it's worth naming gently. When you put someone on a review, you've implicitly asked them to find something. A section they have no notes on can feel, to the reviewer, like a section they didn't really do their job on. So a comment appears. Not because the work needs it, but because being asked to review invites a response. Nobody's acting in bad faith here. The process is quietly nudging good people to leave a mark, sometimes on a section that was already right.

That's the thing to sit with. None of this is difficult people being difficult. It's what any reasonable person does when you hand them a long document and a broad mandate to weigh in. The problem isn't the reviewers. It's that the process asked everyone to have an opinion on everything.

What the regulations actually require

Here's the part worth knowing. Neither the standard nor the regulation says every function has to sign the whole document. They don't say how many signatures you need, and they don't say who has to sign.

Under the QMSR, which took effect February 2, 2026, Part 820 now incorporates ISO 13485:2016 by reference, so document control lives in clause 4.2.4. What 4.2.4 asks for is straightforward: documents get reviewed and approved for adequacy before they're issued, and when they change, they get reviewed and approved again by the original approving function or another designated function that has the background to make the call. That's it. It's about competent review by the right people. It says nothing about routing every document past every department.

The old QSR language most of us grew up on said the same thing in different words. 21 CFR 820.40 told you to designate an individual, or individuals, to review and approve documents before issuance, and to document that approval with a date and signature. Designated individuals. Not the whole org chart.

And 21 CFR Part 11? Part 11 governs how an electronic signature works. That it's linked to the record, that it can't be lifted and reused, that there's an audit trail behind it. It has plenty to say about the integrity of a signature and nothing to say about how many of them you need to pile onto one document.

So the pile-up isn't a regulatory requirement. It's a habit. A well-intentioned one, but a habit, and habits can be changed.

The fix: sign at the item level

The move is to stop treating the document as one big indivisible thing that everyone signs, and start treating it as a set of controlled items that each get signed by the one person who actually owns them.

The person who owns secure coding signs the secure coding item. The validation lead signs the test strategy item. DevOps signs the branching and CI/CD item. Each reviewer approves only the piece they're competent to approve, which, again, is exactly the competent review that 4.2.4 is asking for. Not more people looking at everything. The right person looking at the right thing.

This also closes the door on the review-cycle spiral. A reviewer who only sees their own item can't leave notes on seven sections that aren't theirs. They can't reopen another team's settled decision on the next pass. They aren't staring down forty pages they were never going to read closely anyway, so nothing gets missed on the first pass and resurrected on the third. And the ego nudge has nowhere to land, because there's no sprawling document to prove you read. There's one item you own and can actually judge. You sign it, and you're done.

Once the items are signed, the full document rolls up from parts that are already approved. The document-level signature stops being the bottleneck and becomes what it should have been all along: a short confirmation that the pieces are complete, consistent, and ready to issue. Two signatures do that job. One from operations, the person who owns the plan as a whole and confirms it hangs together. One from quality, confirming the process was followed and the item-level approvals are all in place.

Before and after

Before

The SDLC plan routes to nine approvers, each signing the entire document. Security waits on Regulatory. Regulatory waits on DevOps. People comment on sections that aren't theirs, disagree with edits they're not the deciders on, and each pass turns up new comments the last pass missed, so the cycles keep spawning.

One person is out, one comment on a section nobody owns freezes everything, and any edit means re-routing to all nine. Elapsed time: weeks. Real review happening: less than it looks.

After

The plan is a set of items, each signed by its owner.

• Requirements management approach, signed by Product
• Design and architecture approach, signed by the Software Lead
• Secure coding and access control, signed by Security
• Version control, branching, and CI/CD, signed by DevOps
• Test and validation strategy, signed by the Validation Lead
• Risk management integration, signed by the risk owner
• Configuration and release management, signed by Release Engineering

Each person signs their part, on their own schedule, focused on the thing they know best. Security is done in ten minutes because they're looking at the one section they care about instead of skimming thirty-nine pages they don't. Then the document rolls up, and it needs exactly two signatures to issue: operations and quality. When someone later updates the test strategy, only the Validation Lead re-signs that item. The other six owners never get pulled back in.

Same rigor. Arguably more, since the people approving now actually have the expertise for what they're approving. A fraction of the calendar time.

How Ketryx does this

This is built into how Ketryx works. Because the plan is composed of controlled items rather than a flat file, you can sign at the item level and let the full-document approval roll up from parts that are already reviewed. Every signature is captured as a Part 11-compliant record with the audit trail behind it, so what you get is stronger evidence, not weaker. The reviewers who only care about one thing sign one thing. The two people who own the big picture keep the big picture. And the document that used to sit in routing for three weeks goes out the door in a day or two.

This isn't just hypothetical either. Foresight Diagnostics saw their documentation cycle speed up by 5X after moving onto Ketryx, going from days down to a single day. When the review stops being a signature stampede, the calendar time comes back.

Develop fast, stay compliant. Getting there starts with not asking nine people to sign something seven of them didn't need to read.