Pharma Projects With Documents, Dates, and a Trail
Coordinate development programmes, tech transfer, and site work on infrastructure you control, with versioned documents and a permanent record of every change.
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What does pharmaceutical project management need?
Pharma projects run long, involve several organisations, and are judged on documentation as much as on delivery. A tech transfer or a submission programme touches R and D, manufacturing, quality, and external partners, and every one of them needs the current version of a document rather than the one attached to an old email. Orangescrum manages the programme, the timeline, and the documents around it, and the Self-Hosted edition keeps all of that inside your own environment.
Why pharma programmes drift
Documents, dependencies, and a defensible record
Runs in your environment
The Self-Hosted edition installs on your own servers, private cloud, or an air gapped network, so nothing leaves your control.
Document control
Versioned documents with approval workflows, so the current protocol or procedure is unambiguous. Self-Hosted.
Permanent activity history
Every change, comment, and approval is recorded with the user and the timestamp, and stays with the item.
Long range timelines
Gantt schedules with dependencies, so a slip in one stage shows what it moves downstream.
Controlled access
Role based permissions per project, with SSO, OAuth, and LDAP sign in on Self-Hosted.
Partners on the same plan
Unlimited users means CROs, CMOs, and consultants work in the system with access scoped to their own project.
How a programme is run
Where life sciences teams use it
Which edition includes what
| Capability | CloudManaged SaaS | Self-HostedOn-premise / private cloud | Open SourceCommunity Edition |
|---|---|---|---|
| Projects, tasks, and boards | ✓ | ✓ | ✓ |
| Role based access control | ✓ | ✓ | ✓ |
| Runs on your own infrastructure | ✗ | ✓ | ✓ |
| Document management with approvals | ✗ | ✓ | ✗ |
| Visual workflow designer | ✗ | ✓ | ✗ |
| Risk management | ✗ | ✓ | ✗ |
| Gantt schedule and dependencies | ✓ | ✓ | ✗ |
| Advanced reporting | Premium | ✓ | ✗ |
Pharmaceutical project management FAQ
Is Orangescrum GxP validated or 21 CFR Part 11 compliant?
No. Validation and Part 11 compliance describe how a system is qualified and operated inside your own quality framework, and we hold no such certification. What we can state plainly is that the Self-Hosted edition runs inside an environment you control and can qualify yourself, access is role based, and every work item carries a permanent, attributable history of changes and approvals. Talk to us with your quality team and we will be direct about what we provide and where you would still need a validated system.
Can we keep project data off the public cloud?
Yes. The Self-Hosted edition installs on your own servers, private cloud, or an air gapped network. Nothing is transmitted to us, and backups, retention, and user access are entirely yours to manage.
Is this an eTMF, LIMS, EDC, or QMS?
No, and it is worth saying clearly. Orangescrum does not hold trial master files, laboratory results, clinical data capture, or a formal quality management system with CAPA and deviation handling. It manages the projects around those systems: the plan, the owners, the dates, the risks, and the working documents.
How do we make sure everyone has the current document?
Use document management in the Self-Hosted edition. Documents are versioned with an approval workflow, so the approved version is the one people see, and superseded versions stay in the history rather than circulating by email.
Can external partners like CROs be included?
Yes. Unlimited users on every plan, with role based permissions per project, so a partner sees only its own scope. That removes the usual reason for keeping partner work in a separate spreadsheet.
Can we track dependencies across a multi year programme?
Yes. Gantt schedules carry real dependencies between tasks and stages, so moving one date shows exactly what shifts behind it. Programme views roll several related projects into one picture.
Can we control approvals in the tool rather than by convention?
Yes, in the Self-Hosted edition. The visual workflow designer defines the statuses, which transitions are allowed, and which roles may make each transition, so an approval step cannot be skipped by someone dragging a card.
Do we pay per person?
No. Every plan is a flat monthly price with unlimited users. In pharma that matters because quality, regulatory, and manufacturing reviewers are exactly the people a per seat model tends to exclude.
Run the programme inside your own environment
Cloud or fully self-hosted on your own infrastructure. Every plan includes unlimited users.