Are you struggling with any of these common challenges? Solving them requires partnering with an experienced solution provider who has the knowledge, tools, and experience to help.

Product Complexity

Product complexity is on the rise and will likely continue due to ongoing changes in technology. Working with large volumes of product information, and how the information relates to your supply chain, can have a direct impact on your development efforts. Seapine solutions help simplify complex product information with organizational capabilities based on role. Life science companies are also realizing that they gain better control and security when working with other third-party manufactures and consultants on their projects.

Lack of Project Visibility

As a project- or product-driven organization, management needs insight into the status of their projects. Knowing when to make resource investments, or just managing problematic areas, is not easy without complete visibility and analysis of key development data metrics. Seapine solutions help solve these often disconnected activities for better decision-making.

Poor Decision-Making

Product development traceability should not be considered a one-time compliance exercise or a one-dimensional trace matrix. There are several daily efficiencies that product development traceability can deliver by improving visibility and decision-making. Seapine solutions offer end-to-end, automated traceability, while also streamlining transfers and making analysis a reality for your projects.

Integrating and Mitigating Risk

More and more life science companies are attempting to integrate risk management at the earliest stages of development, when hazards are first identified, largely driven by ISO 14971 and IEC 62304. Seapine solutions are helping life science companies realize the benefits of integrating hazard analysis all the way through to mitigation.

Long Development Cycles

Development methodologies are great ways to help change development team behavior and increase their productivity. Whether your organization has chosen Agile, Kanban, Scrum, Spiral, Waterfall, or a hybrid approach, Seapine provides solutions that are flexible to accommodate any methodology.

Communication Breakdown

While working as a team has its own challenges, working in a distributed model presents an even greater set of communication challenges. To get your team on the same page, you need a single source of truth-ensuring team members can easily work together to meet a common goal. Seapine solutions provide a collaborative framework that enables to can complete, transfer, review, comment, approve, record evidence, escalate, and view the information they need.

Ineffective Design Control

Design control, which is a requirement of most life science companies, can be hard to effectively manage on a daily basis. Seapine solutions have helped many life science companies achieve compliance and control and, more importantly, streamline and document design activities and work.

Manual, Document-Based Processes

A process doesn't need to be manual and document-centric to be repeatable. Seapine solutions provide a streamlined approach to following a compliant process with added benefits of automation, collaboration, organization-and yes, even documentation.

Siloed R&D Activities and Assets

Managing multiple tools and systems during the R&D phase is inefficient and drives up operational costs. The risk of duplication, communication breakdown, and control is very real. Most QMS, EDMS, PDM, and PLM systems lack the strong traceability needed to facilitate a more holistic approach to daily development work. Software tools designed for just requirements, risk, test, or issue management can have more value, but can become siloed if not properly integrated with daily activities. Seapine solutions support multiple engineering disciplines-all in a collaborative, integrated, and traceable framework.

Achieving 21 CFR Part 11 Compliance

The U.S. Food and Drug Administration (FDA) provides specific guidelines on how to control and audit electronic records and signatures. Seapine solutions are designed to support your process—not our interpretation of the FDA guidelines—and help you manage your electronic information. After all, all life science companies are not the same and do not have the same classification, so a solution that supports your processes and your intended use is a basic need.