Solutions for Life Sciences Product Development
Leading medical device, pharmaceutical, biotechnology, and clinical research organizations rely on Seapine Software to manage their core processes, drive innovation, and gain a competitive edge.
Life sciences organizations face constant challenges, including competitors, government regulations, and productivity and quality issues. To remain competitive, life sciences companies must reduce costs, streamline R&D processes, reduce compliance overhead, and accelerate time to market in a compliant manner.
Do your development teams struggle with:
- Swimming in documents
- Mitigating risk throughout the development process
- Creating repeatable processes to ensure quality
- Controlling and tracing all related development artifacts
- Delivering complex solutions on time while controlling costs
- Producing audit-ready reports for device verification and validation
- Complying with FDA and global regulations
It is not an easy task to satisfy all of these challenges and balance the project needs of the organization. Having the flexibility and agility to change or improve processes or methods use to take years to realize benefits. In today's world, organizations require seamless integrated tools to stay competitive.
Seapine solutions can be configured to meet regulatory compliance standards, such as EU, FDA, IEC, ISO, HIPAA, ISO, and Sarbanes-Oxley. This includes meeting or exceeding FDA regulations for 21 CFR Part 11, IEC 62304 & 60601, ISO 14971 & 13485, and cGMP, in addition to helping meet 21 CFR Part 820 QSR compliance and completing GxP assessments.
Beyond the obvious compliance benefits, product development should also expect:
- Streamlined design transfers
- Improved visibility and insight
- Integrated risk management
- Stronger analysis and reporting
- Better decision making
- Greater development agility
- Faster delivery with higher quality
- Increased productivity and morale
- Compliant security and auditing
- Leverage existing technology
Seapine Software's integrated life sciences solutions help companies manage regulatory compliance initiatives by tracking and linking product development artifacts, verification and validation artifacts, internal validated IT systems, and other mission-critical activities—all without interrupting daily activities.
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Break Down the Silos
Most product development teams work in individual silos with no visibility across disciplines. This creates 3 key challenges to delivering a competitive product to market, within time and budget constraints. Seapine product development solutions provide a single source of truth, solving these challenges.
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Solution Brief: Life Sciences Solution Brief
White Paper: How to Have a Painless FDA Audit
White Paper: Impact of 21 CFR Part 11 on Software Development
Customer Story: Ximedica Improves Compliance and Cuts Costs with Seapine
We don't have to fight with Microsoft products when we make changes. TestTrack is a perfect fit that allows us to bring everything together and fully document our design process.