Life sciences companies face some of the strictest regulatory environments in the world. From FDA and EMA oversight to global standards like ISO 13485 and GDPR, compliance requirements touch every part of the business.
Yet many teams still rely on a patchwork of spreadsheets, shared drives, or oversized enterprise systems that either fail to meet compliance needs or bury smaller companies in cost and complexity.
Healthcare compliance management software is meant to solve these challenges, but not all platforms are created equal. The right system should make compliance a foundation of daily operations, not an afterthought. It should integrate quality, regulatory, and clinical functions into one source of truth, while remaining flexible enough to adapt to how teams already work.
That’s the approach Kivo takes. Built specifically for life sciences, Kivo delivers enterprise-grade compliance without enterprise-level overhead. And in this guide, we'll walk you through the eight most common questions life sciences professionals ask when evaluating healthcare compliance management software.
What is healthcare compliance management software, and how does Kivo approach it differently?
Healthcare compliance management software is designed to help life sciences teams meet the strict requirements of FDA, EMA, and other global regulators. At its core, it provides tools for controlling documents, managing training, capturing audit trails, and ensuring processes meet standards like 21 CFR Part 11, HIPAA, and ISO 13485.
The challenge is that many platforms fall at one of two extremes.
On one side, you have generic tools like SharePoint or Google Drive. These can store documents, but they don’t provide the audit trails, electronic signatures, or validation needed for regulated environments.
On the other side, you have heavy enterprise systems like Veeva or MasterControl. These are compliance-ready, but they’re expensive, rigid, and often force smaller teams to change the way they work just to fit the software.
Kivo takes a different approach. Our platform was built specifically for life sciences teams who need enterprise-grade compliance without the bloat or cost of traditional systems. Instead of splitting quality, regulatory, and clinical into separate silos, Kivo uses a single underlying document management foundation. That means one version of truth across submissions, SOPs, training records, and trial master files. The result: less rework, fewer version conflicts, and a smoother path to inspection readiness.
Kivo’s design is also flexible enough to adapt to how your team already operates. You don’t have to rewrite all your processes just to get compliant. The system supports your workflows while ensuring every action is tracked, every signature is valid, and every document is ready for audit.
How does compliance software help meet requirements like 21 CFR Part 11, HIPAA, GDPR, or ISO 13485?
For life sciences companies, compliance isn’t optional. Regulations like 21 CFR Part 11, HIPAA, GDPR, and ISO 13485 dictate not only how records are kept, but also how they’re signed, shared, and preserved over time. The challenge is that traditional document storage tools don’t have the built-in controls needed to satisfy these requirements. A simple folder structure in SharePoint can’t produce immutable audit trails, ensure data integrity, or validate electronic signatures.
This is where compliance management software is supposed to step in. The problem is, many platforms still treat compliance as an afterthought, bolting on audit features rather than designing for them. That leads to gaps during inspections and extra effort for teams who need to prove their processes are secure.
Kivo was designed from the ground up with compliance at its core. The platform automatically enforces 21 CFR Part 11 requirements, capturing every action in a validated audit trail. Electronic signatures are built into workflows, ensuring sign-offs meet regulatory expectations without adding unnecessary complexity. For HIPAA and GDPR, Kivo protects sensitive data through encryption in transit and at rest, along with strict role-based access controls. For ISO-certified environments, Kivo provides structured document control and training management that aligns with quality system requirements.
By embedding compliance into every layer of the system, Kivo removes the risk of manual gaps. Teams don’t have to wonder if their documents or processes will hold up in an inspection. The platform makes compliance the default setting, so life sciences companies can focus on advancing their programs rather than second-guessing whether their systems are inspection-ready.
Can the software integrate quality, regulatory, and clinical processes into a single system?
One of the biggest frustrations for life sciences teams is working across disconnected systems. Quality might sit in one tool, regulatory submissions in another, and clinical trial documents in yet another. Each platform requires separate logins, separate training, and separate validation cycles. More importantly, information doesn’t flow freely between them. Teams end up duplicating documents, revalidating the same records in multiple places, and wasting time reconciling different versions of the truth.
This siloed approach creates real risks during audits and inspections. Regulators expect to see clear traceability across functions: SOPs tied to training records, quality events linked to regulatory submissions, clinical data tied back to trial master files. When these connections live in different systems, proving compliance becomes a scramble.
Kivo solves this problem by unifying quality, regulatory, and clinical processes in a single platform. Instead of stitching together separate modules, Kivo uses one underlying document management foundation for all functions. A change to an SOP flows automatically into training records. Regulatory teams can access the same validated documents that quality and clinical teams rely on, without creating duplicates. Every department is aligned to a single source of truth.
This integration eliminates the revalidation burden that comes with multiple systems. It also reduces the risk of version conflicts or missing records. Whether you’re preparing for a regulatory submission, managing a CAPA, or setting up a trial master file, all teams are working in the same environment. That makes compliance more efficient and keeps the focus on advancing programs instead of chasing down documents.
How does the system handle validation and reduce the burden on my team?
Validation is one of the heaviest lifts for any life sciences company adopting new software. Regulators expect proof that the system works as intended and consistently enforces compliance controls. For many platforms, this means lengthy validation cycles every time a new update is released. Teams are forced to dedicate resources to testing, documentation, and sign-offs, which slows down adoption and drains time away from higher-value work.
The problem is even worse with enterprise systems that deliver frequent updates or require customers to perform their own full-scale validation. Smaller teams can’t keep up, so they either delay upgrades or operate with unvalidated systems — both of which create compliance risks.
Kivo takes a more balanced approach. The platform offers pre-validated environments that meet FDA expectations while still giving teams the flexibility to configure workflows for their unique needs. Instead of starting validation from scratch, customers inherit a validated baseline and only need to validate the parts they choose to customize. This significantly reduces the time and effort required to stay compliant with every release.
By reducing the validation burden, Kivo allows life sciences companies to move faster without compromising inspection readiness. Teams can adopt new features, adjust workflows, and scale programs knowing that the core system has already been validated to regulatory standards.
How customizable is the platform to our workflows?
Every life sciences company operates differently. Some teams run lean and prioritize speed. Others build highly structured processes with multiple approval layers. The challenge with most compliance software is that it forces companies into rigid templates. Instead of supporting existing workflows, the system dictates how work gets done. This often leads to frustration, workarounds outside the system, and gaps in compliance.
Kivo was built to avoid this trap. The platform provides configurable workflows that adapt to how your team already operates. Approval paths, training assignments, and CAPA processes can be set up to mirror your current approach, rather than requiring you to redesign it. For emerging biotechs, this means being able to start simple and add complexity as the organization grows. For established companies, it means aligning the software to existing SOPs without triggering costly process overhauls.
A good example is how a service provider working with early-stage biotechs used Kivo to build their quality foundation. Instead of adopting a one-size-fits-all template, they configured Kivo to support each client’s unique processes while still maintaining compliance controls. This flexibility allowed them to meet regulatory expectations without disrupting day-to-day operations.
With Kivo, flexibility and compliance work together. Teams stay inspection-ready while keeping processes that make sense for their business.
How does the system support audits and inspections?
Audits and inspections are where compliance systems prove their worth. A regulator might ask for training records tied to a specific SOP, a change history on a submission document, or proof that a CAPA was followed through from initiation to closure. If records are scattered across systems, or worse, buried in shared drives and email chains, pulling this together under time pressure becomes a stressful, error-prone process.
Kivo makes inspections easier by design. Every action in the system is automatically tracked in an immutable audit trail. Electronic signatures are fully Part 11 compliant and tied directly to workflows, so approvals can be shown without additional paperwork. Documents, training records, and change histories can be surfaced instantly, giving auditors a clear view of compliance without requiring your team to scramble behind the scenes.
By consolidating quality, regulatory, and clinical data into a single platform, Kivo gives teams confidence walking into any audit. Everything is centralized, traceable, and accessible, which means no surprises when regulators ask for proof.
How does Kivo compare in cost to enterprise systems like Veeva or MasterControl?
For many life sciences companies, the biggest barrier to adopting enterprise compliance software isn’t functionality, it’s cost. Systems like Veeva or MasterControl come with multi-year contracts, steep license fees, and professional services costs that can quickly reach into the millions. For large pharma, that might be manageable. For emerging biotechs, medtech startups, or mid-sized companies, it’s often out of reach.
This pricing structure creates a gap in the market. Smaller organizations still need enterprise-grade compliance to satisfy regulators, but they’re left choosing between expensive platforms they can’t sustain or generic tools that don’t hold up in an audit. Neither option is practical for growing teams under inspection pressure.
Kivo was designed to close that gap. The platform delivers the same level of compliance rigor as enterprise systems but at a cost structure aligned with growing organizations. Companies can implement Kivo without committing to oversized contracts or diverting budget away from critical R&D. As programs expand, the system scales with them — providing enterprise-grade compliance that stays affordable at every stage of growth.
This balance of compliance and cost is why many companies view Kivo as the sweet spot between spreadsheets and enterprise tools. It enables teams to meet regulatory expectations today while building a foundation that can support them as they scale.
What proof is there that Kivo works in real-world life sciences environments?
When evaluating compliance software, teams want more than promises. They want evidence that the system works in practice, under the same regulatory pressures they face. Real-world examples show whether a platform can scale programs, handle inspections, and adapt to the complexities of life sciences.
Kivo has a track record across pharma, biotech, and medtech companies of all sizes. For instance, Elpida used Kivo’s GxP solution to support their mission of bringing life-saving therapies to market. With Kivo, they were able to keep their processes inspection-ready while managing the demands of rapid development.
At Hyloris, the challenge was scale. Their programs were increasing rapidly, and the company needed a way to expand regulatory, clinical, and quality operations without drowning in manual work. By unifying these functions in Kivo, Hyloris kept compliance under control while doubling programs from 10 to 20 over two years.
And for Elevar Therapeutics, Kivo enabled the migration of 19 TMFs in just 72 days. That level of speed and precision gave them inspection-ready data across all programs and eliminated the chaos of managing trial files across disconnected systems.
These case studies reflect what Kivo delivers in practice: enterprise-grade compliance that adapts to the way teams actually work, without the cost and rigidity of traditional enterprise tools.
We understand that newer technology and new brands in this space can feel riskier than long-established players, but here's the reality: with today's competitive landscape, tight timelines, and limited funding, spending hundreds of thousands of dollars on a 6-12 month rollout of legacy software is by far the riskier option.
Click below to speak with our experienced team of life sciences veterans and see what so many small and midsized teams have successfully transitioned to Kivo.
