--- title: "Pharmaceutical Project Management | Orangescrum" description: "Project management for pharmaceutical and life sciences teams, with a self-hosted edition that keeps data inside your validated environment." canonical: https://www.orangescrum.com/solutions/project-management-software-for-pharmaceutical-industry --- # Pharmaceutical Project Management | Orangescrum > For the complete documentation index, see [llms.txt](https://www.orangescrum.com/llms.txt). [Home](/) / [Solutions](/solutions) / Pharmaceutical Pharmaceutical # 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. Recommended editions[Cloud](/pricing "Cloud - included")[Self-Hosted](/self-hosted "Self-Hosted - included")Open Source [Start Free Trial →](/sign-up?utm_source=website&utm_medium=feature&utm_content=solutions/project-management-software-for-pharmaceutical-industry)[Book a Demo](https://calendly.com/orangescrum) Free forever plan · No credit card required · Set up in minutes ## 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. The problem ## Why pharma programmes _drift_ Two versions of the same procedure are in use A revised protocol is emailed to some people and not others, so a site works to a superseded document. ✓ Versioned documents with approvals, one current version. Partner work is invisible until it is late A CRO or contract manufacturer reports monthly, so a four week slip is discovered in week five. ✓ Partners inside the plan with access to their own scope. Long timelines lose their dependencies A study, a filing, and a manufacturing readiness date are tracked in three separate files that nobody reconciles. ✓ One timeline with real dependencies between them. Nothing is ready when quality asks Evidence of who reviewed and approved a change is reassembled after the fact. ✓ Permanent activity history on every item. What matters here ## 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 it works ## How a programme _is run_ 1 Deploy where quality allows Self-hosted inside your own validated environment, or cloud where policy permits. 2 Set roles and document control Define who can review and approve, and put the controlled documents under versioning. 3 Build the programme timeline Link development, manufacturing, and regulatory work so the dependencies are explicit. 4 Track and evidence Progress, risks, and approvals update as the work happens, so the record is already there. Who it's for ## Where life sciences teams _use it_ Tech transfer Coordinating a product move between sites or partners. [Learn more →](/program-management-software) Document controlled work Protocols and procedures with versions and approvals. [Learn more →](/document-management) Change and risk tracking Programme risks with owners and mitigations. [Learn more →](/risk-management) Availability ## Which edition includes _what_ Orangescrum runs as managed cloud, self-hosted on your own servers, or as the open-source Community Edition. Here is exactly what each one includes. Available in Cloud and Self-Hosted. Self-hosted is the usual choice here. | 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 | ✓ | ✗ | Frequently asked questions ## 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. [Start Free Trial →](/sign-up?utm_source=website&utm_medium=feature&utm_content=solutions/project-management-software-for-pharmaceutical-industry_cta)[Book a Demo](https://calendly.com/orangescrum) ## Related capabilities [Self-Hosted editionRun it on your own servers](/self-hosted)[Document managementVersions and approvals](/document-management)[Risk managementOwners, impact, mitigation](/risk-management)[Gantt chartLong range dependencies](/gantt-chart)