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.
What sits next to the regulated process
Six pieces of coordination, kept clearly separate from validated systems.
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.
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.
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.
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.
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.
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.
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.
Treat it as a plain internal record, not audit evidence. It shows a page's edit history and who changed it, which is genuinely useful for your own team's memory of a decision. But it is not a validated, GxP-recognised audit trail, and we don't present it as one.
No. There's no clinical-trial-management-system or eTMF integration. ShipSprint sits alongside those systems as a planning and tracking board for the team's coordination work, not as a connector into your regulated systems of record.
A Business subscription at ₹599 per user monthly, or ₹6,499 yearly, covers every function on one bill, including forecasts and the owner command center. Smaller teams can pilot on Free with up to 5 users. See pricing for the complete breakdown.
No. Keep boards to project and coordination data: tasks, timelines, who's reviewing what. Batch records, study data and anything that belongs in a validated system of record should stay in the validated systems built and qualified for that purpose, not in a task description here.
We're not going to speculate on a roadmap item here. What's true today is stated plainly: ShipSprint is not validated and makes no compliance claim of any kind, and nothing on this site should be read as implying otherwise.
Related pages
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