In the pharmaceutical industry, documentation isn’t just paperwork. It's proof that your processes are compliant, your team followed protocol, and your product is safe.
Every SOP, batch record, and change control form must be accurate, up-to-date, and audit-ready.
But for many life sciences teams, managing that documentation is still harder than it should be.
You’re either stuck in a rigid, over-engineered system that doesn’t adapt to how your team works... or you're cobbling together SharePoint folders, spreadsheets, and email threads, hoping nothing falls through the cracks before an inspection.
At Kivo, we believe pharmaceutical document management should support how you work, not the other way around.
In this guide, we’ll cover the core challenges pharma teams face with managing their documents, and the modern tools, approaches, and options available to solve those challenges.
Pharmaceutical document management is the process of creating, organizing, reviewing, approving, and securely storing the documents that support your regulated operations.
These aren’t just internal records. Every document is auditable evidence of how your company complies with FDA, EMA, and other global regulatory requirements.
A pharmaceutical document management system (DMS) provides the infrastructure to manage:
Standard Operating Procedures (SOPs)
Manufacturing batch records and quality control logs
Deviation and CAPA documentation
Change control forms and approval workflows
Employee training records
Regulatory submission content (e.g. Module 3, 2.7/2.5, etc.)
The goals here go far beyond storage. A great DMS is ultimately about quality control.
That means full version history, electronic signatures, audit trails, access controls, and structured workflows. It also means your team can quickly retrieve the right version of the right document, even under the pressure of a surprise audit.
A modern pharmaceutical DMS serves as the backbone for your Quality Management System (QMS), Regulatory Information Management (RIM), and clinical operations. And when all three are built around the same DMS (what makes Kivo a uniquely great option for pharma teams), you eliminate silos, reduce revalidation, and create a single source of truth across your organization.
If you’ve ever spent an afternoon digging through folders to find the “right” version of an SOP before an audit, you already know that managing documentation in pharma requires a combination of organization, control, traceability, and audit-readiness.
Here are some of the most common challenges we hear from pharmaceutical teams:
When quality, regulatory, and clinical teams each manage documents in their own tools (SharePoint for SOPs, email chains for CAPAs, Excel for tracking updates), nothing works in sync. That means duplicate files, conflicting versions, and missed steps in critical processes.
Without a strong DMS in place, teams often rely on arbitrary naming conventions like “SOP_v4_FINAL_FINAL” to manage version control. It’s easy to reference the wrong version during training, in a submission, or worst of all, during an inspection.
Some systems make it impossible to configure review workflows without IT help. Others don’t support structured reviews at all. That leads to bottlenecks, missed approvals, and unclear accountability, all of which are audit findings in the making.
Every software update shouldn’t trigger a months-long revalidation effort. But in many legacy systems, it does. That keeps teams stuck on outdated versions or drowns them in paperwork just to stay current.
Whether you're following ISO, ICH, or site-specific SOPs, your processes are unique. But most legacy platforms force teams into rigid workflows or require massive expenditures to customize, creating unnecessary workarounds, frustration, and compliance gaps.
When choosing or developing your pharma document management system, prioritize platforms and processes that support how your team works while meeting the strict expectations of regulatory bodies.
Whether you're preparing for a pre-approval inspection or scaling toward commercialization, here are the features that matter most:
Your system must include electronic signatures, system access controls, and full audit trails to comply with FDA and global regulatory requirements. Look for platforms that are validated and come with documented evidence of compliance.
You should never have to guess which version is current. A good DMS ensures that every document has a single active version, with complete change history, so teams always work from the correct file and can prove it.
No two pharma companies operate the same way. Your DMS should allow you to define custom document types, metadata, and routing logic that match your established processes without expensive custom development.
Most pharma teams manage documents across QMS, RIM, and clinical workflows. A modern DMS should eliminate the need to sync or copy between modules, enabling a single source of truth and reducing the risk of errors or revalidation.
Especially for distributed teams and CRO partners, cloud-native access is critical. Look for systems that offer role-based permissions, SSO, SOC 2 Type II certification, and data encryption both in transit and at rest.
You need to be able to generate training status reports, CAPA summaries, or controlled document lists in minutes, not hours. Built-in reporting and dashboards save time and support faster responses during audits.
Most life sciences teams choose from four common approaches to manage their regulated documentation. Each comes with trade-offs in compliance, scalability, and usability. Here’s how they stack up:
Many early-stage pharma teams rely on tools like Excel, SharePoint, or Google Drive to manage documents. While this setup is fast and familiar, it lacks the foundational controls needed for compliance, including version control, audit trails, and workflow automation. It may work during preclinical development, but quickly becomes a liability as you approach IND, NDA, or commercialization.
Tools: Excel, Google Sheets, SharePoint, Dropbox
✅ Pros: Low cost, easy to use, minimal setup
❌ Cons: No version control, no audit trails, high compliance risk, manual review tracking
🔎 Best for: Preclinical teams or temporary stopgaps
Point solutions are specialized tools built to manage a specific slice of the document lifecycle, like SOP training, CAPA tracking, or eTMF management. They’re often lightweight and easy to deploy, but they don’t scale well. Teams end up duplicating documents across systems, losing traceability, and creating gaps that show up during audits or inspections.
Tools: Training management tools, CAPA trackers, eTMF-only systems
✅ Pros: Solves a specific problem well, often simple and user-friendly
❌ Cons: Creates silos, requires duplicate document storage, lacks system-wide control
🔎 Best for: Teams with narrow needs and no plans to scale in the near term
Enterprise platforms like Veeva Vault and MasterControl offer powerful functionality for global organizations with complex regulatory needs. They’re validated, widely used, and feature-rich, but often require long implementations, costly configurations, and dedicated admin resources. For smaller or fast-moving teams, these systems can feel overly rigid and slow to adapt.
Tools: Veeva Vault, MasterControl, OpenText
✅ Pros: Deep functionality, validated at scale, enterprise integrations
❌ Cons: Rigid workflows, high cost, long implementation cycles, requires IT/admin overhead
🔎 Best for: Large commercial-stage companies with complex global operations
Modern platforms like Kivo are designed for life sciences teams that need enterprise-grade compliance without the enterprise cost and technical baggage. With built-in validation, configurable workflows, and a unified DMS across QMS, RIM, and clinical, Kivo offers a powerful alternative for pharma companies scaling toward clinical trials or commercialization. It’s flexible, intuitive, and ready to support how your team actually works.
Tools: Kivo
✅ Pros: Part 11 compliant, configurable to your SOPs, fast implementation, single source of truth
❌ Cons: May not include niche enterprise features some global teams require
🔎 Best for: Small to mid-sized pharma companies scaling up toward clinical or commercial launch
| Feature / Factor | Spreadsheets & Drives | Point Solutions | Enterprise Systems | Platforms Like Kivo |
|---|---|---|---|---|
| Part 11 Compliance | ❌ No | ❌ Usually not | ✅ Yes | ✅ Yes |
| Version Control | ❌ Manual | ✅ Partial (per tool) | ✅ Full | ✅ Full |
| Audit Trails | ❌ None | ❌ Limited | ✅ Yes | ✅ Yes |
| Configurable Workflows | ❌ Manual | ❌ Not system-wide | ❌ Rigid | ✅ Fully configurable |
| Single Source of Truth | ❌ No | ❌ No | ❌ Often fragmented | ✅ Yes |
| Ease of Use | ✅ Familiar | ✅ Easy for one task | ❌ Steep learning curve | ✅ Built for real workflows |
| Implementation Time | ✅ Immediate | ✅ Fast | ❌ Months | ✅ Weeks |
| Cost | ✅ Low | ✅ Moderate | ❌ High | ✅ Mid-range |
| Best Fit For | Early-stage / Preclinical | Narrow, task-specific use | Large enterprise teams | Scaling clinical / commercial |
Kivo was built specifically for the needs of modern life sciences teams, especially those looking for enterprise-grade compliance without enterprise-grade complexity or cost.
Here’s how Kivo helps pharmaceutical companies streamline document management, stay inspection-ready, and scale faster:
Unlike systems that patch together QMS, RIM, and eTMF tools with separate document repositories, Kivo uses a single, validated DMS across all modules. That means no syncing, duplicating, or revalidating the same document in multiple places.
Kivo doesn’t force a prescriptive model. You can configure document types, metadata, review workflows, and routing rules to match your existing SOPs, whether you’re ISO-certified, following ICH guidelines, or managing regional regulatory nuances.
Kivo is 21 CFR Part 11 compliant, GxP validated, and SOC 2 Type II certified. Electronic signatures, audit trails, controlled access, and training triggers are built in rather than bolted on.
Our risk-based validation approach means you don’t have to revalidate your entire system with every minor update. We provide detailed validation documentation, so you stay compliant without falling behind.
Need to show which SOPs were trained on before a new batch run? Or generate a list of expiring quality documents before an audit? Kivo gives you real-time visibility into the state of your documentation, no spreadsheets required.
Pharmaceutical teams today operate under constant pressure to move fast, stay compliant, and be inspection-ready at any moment. But outdated or fragmented document management systems make that harder, not easier.
Whether you’re still relying on spreadsheets, stuck in a rigid legacy system, or juggling disconnected point solutions, there’s a better way.
Kivo gives you the compliance foundation you need with the flexibility your team actually wants.
One source of truth. One platform across QMS, RIM, and eTMF. Fully configurable to match your SOPs, not someone else’s playbook.
Click below to book a demo, and we’ll show you how real pharmaceutical teams are streamlining reviews, passing audits with confidence, and scaling faster with Kivo.