INDUSTRY

Project Management Software for Pharmaceuticals

Documented process next to delivery, from a tool that is not validated software and does not claim to be. Said first, not buried.

Say the hard part first: this is not validated software

ShipSprint is not GxP validated software. It is not 21 CFR Part 11 compliant. We make no such claim, in any wording, anywhere on this site: not "helps you stay compliant," not "supports your validation effort," nothing that implies a capability we don't have. If your process requires validated software with electronic-signature compliance for GxP records, that requirement sits entirely outside what this tool is or does, and no amount of careful phrasing changes that. Read that twice before reading anything else on this page, and if it rules ShipSprint out for a specific regulated system, take that as the correct answer rather than something to work around.

With that said plainly, here's what regulated development work in a pharma organisation actually looks like day to day, underneath the formal systems: formulation, quality and regulatory affairs teams coordinating a study or a change, needing the sequence documented. This review happened before that change was made, this step was signed off before the next one started. That coordination work is real, distinct from the formal GxP record itself, and it's what ShipSprint is built for.

Take an ordinary week on a formulation change: quality needs to review the proposed adjustment before formulation starts trial batches, regulatory affairs needs to know as soon as the review clears so they can assess filing impact, and someone needs a written note of why the change was made at all, for the next person who asks in six months. None of that requires validated software. It requires a shared board, a place the reasoning gets written down, and a way to see that the review actually happened before the next step started.

The honest way to use it: keep your batch records, your validated CTMS, your eTMF and your LIMS exactly where they are, in the systems built and validated for that job. Use ShipSprint next to them, as the board where the human coordination happens (who's doing what, by when, and a plain internal record of why), never as a substitute for the regulated system of record itself.

How it works

What sits next to the regulated process

Six pieces of coordination, kept clearly separate from validated systems.

A page history, not an audit trail

A built-in wiki keeps decisions next to the work they affect, and every page carries its edit history: a plain internal record that a step was discussed and when, useful for your own team's memory of why a call was made, not offered as GxP evidence and not described as such anywhere on this site.

Handoffs between functions, tracked

Boards carry per-column WIP limits and a shared triage inbox, so a request moving from formulation to quality to regulatory affairs doesn't stall because nobody noticed it arrive.

A timeline slip flagged early

Delivery forecasts come from the team's measured velocity as sprints close, so a study milestone drifting off track shows up weeks ahead (while there's still room to add hands or adjust scope) rather than on the date it was due, when the only real options are apologising or working through the weekend.

Hours logged without the Friday scramble

Logging a day's time takes about five seconds and sits next to the task just finished, with the reminder for a missing day going to the individual, not escalated to a manager.

One "my day" screen, one tap when stuck

Everyone opens to today's items and a one-tap log, with a single tap for "I'm blocked" pulling in the right person with context attached, useful when a handoff between functions stalls on a question, not a process failure.

One view across programmes

The owner command center answers "where are we?" across every study or programme at once, with a Monday digest that arrives without anyone compiling it by hand.

What is true, exactly, and nothing beyond it

Four facts, stated completely: every workspace is an isolated tenant, two-factor authentication is available to every user, every admin action is written to an audit log, and the entire workspace exports as JSON at any time. That's the whole list. There's no GxP validation, no 21 CFR Part 11 compliance, no SOC 2 report, no ISO 27001 certificate, and no integration with a clinical-trial-management system of any kind.

We think that honesty is worth something on its own in this category, where "compliant" gets used loosely by vendors selling coordination tools into regulated pipelines. A page that says plainly what it isn't, and stops there, is easier to trust on the parts it does claim. If you've evaluated other tools in this space, you've likely already seen the softer version of this same gap: a claim like "supports GxP workflows" that, read closely, promises nothing specific at all.

If a formal validation requirement applies to any part of your workflow, treat this as outside that boundary entirely: a planning and tracking layer for the people doing the work, not a system that touches your regulatory submission.

Who this suits: R&D, quality, regulatory affairs and operations teams who need to plan, track and forecast the human coordination around a regulated development programme. Who it doesn't suit: any workflow where the software itself must be part of the validated, GxP-recognised system boundary. That's a hard requirement this product doesn't meet, and no amount of adjacent usefulness changes that fact.

One subscription across R&D, quality and regulatory

R&D, quality and regulatory affairs typically run on separate tools bought at different times for different reasons, each with its own renewal to track. ShipSprint charges per seat, once, so a study spanning all three functions sits in a single subscription. In practice that means a regulatory affairs lead can see the same board a formulation scientist is working from, instead of waiting on a status email to cross a department line.

  • R&D, quality, regulatory affairs and operations each get their own templates and vocabulary on the same subscription, so a study spanning three functions doesn't need three separate tools to track it.
  • ShipSprint connects to Claude and ChatGPT, so a team lead can ask "what's overdue on this study this sprint" in plain language instead of checking five boards.
  • Free covers up to 5 users and 2 projects, indefinitely. Team is ₹299 per user monthly, or ₹2,899 yearly, for up to 40 users. Business is ₹599 per user monthly, or ₹6,499 yearly, and adds forecasts, scorecards and the owner command center.
  • Every paid plan starts with a 14-day full-access trial on Business, a sample project preloaded, no card required to begin.
  • GST-compliant invoices are issued automatically each cycle, and annual billing is available for teams that would rather set it once and move on.
FAQ

Common questions

No, on both counts, plainly. ShipSprint is not GxP validated software and is not 21 CFR Part 11 compliant. We make no version of that claim anywhere on this site. If either is a requirement for part of your workflow, that part sits outside what this tool is built to do.

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