2016 Life Sciences Product Development Report
Gain valuable insights into how organizations manage product development artifacts, compliance, and traceability in the R&D phase.
Life science organizations face constant challenges from competitors, government regulations, productivity and quality issues, and more. To remain competitive, organizations must reduce costs, streamline R&D processes, reduce compliance overhead, and accelerate time to market in a compliant manner.
Are your development teams struggling with:
- Manually managing documents?
- Mitigating risk throughout the development process?
- Creating repeatable processes to ensure quality?
- Controlling and tracing 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?
Overcoming these challenges, while balancing the project needs of the organization, is not easy. To stay competitive, you need seamlessly integrated tools, along with the flexibility and agility to change or improve processes and methods.
Seapine's integrated life science 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.
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, you can 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