Our solutions help diverse groups of business and IT stakeholders around the globe easily collaborate to drive consensus and resolution as they innovate on large pharmaceutical industry initiatives. Discussions and comments are saved in a shared, centralized repository, so the organization can always reference why important decisions were made.
Compliance with regulations, like 21 CFR Part 11 and GMP Annex 11, FDA, ISO, Good Manufacturing Practices, policies, and best practices ensures quality, reduces risk, and prevents the costly consequences of non-compliance. Our solutions help you achieve it and maintain it as requirements change. Detailed traceability and reporting capabilities provide robust support for audits – even down to a very detailed level – so you can prove compliance when needed.
Blueprint provides end-to-end visibility of both Agile and traditional IT requirements in one place, so you can share information and corporate knowledge easily within your organization and with other pharmaceutical partners. Management analytics and reporting capabilities provide you with valuable insight to guide direction and pivot when needed.
With Blueprint, your pharmaceutical organization benefits from fewer defects, less rework, and improved speed through strong business and IT alignment. Everyone has a shared understanding and you know that requirements – whether Agile user stories or traditional requirements – align with corporate strategy.
Blueprint’s Content Accelerators speed delivery and improve quality for pharmaceutical organizations by providing easy access to predefined, validated, reusable sets of requirements information, including expert interpretations and requirements for many common industry regulations, like 21 CFR Part 11 and GMP Annex 11, addressing electronic records and electronic signatures. We also provide an industry-leading Non-Functional Content Accelerator, empowering teams with a library of categories and elicitation questions for common non-functional requirements, like those for performance, security, and compliance. Teams don’t start with a blank page, and they always know they have the most current regulatory information.Learn More
With precise traceability between requirements, tests, and supporting information, teams can easily navigate between related artifacts, like process models, user stories, and test results to ensure requirements and test case coverage. These connections also provide pharmaceutical organizations with the ability to confirm they have delivered what is needed to prove achieve, maintain, and prove compliance, an undeniably critical need for healthcare organizations today.Learn More
Blueprint’s powerful impact analysis capabilities enable teams to quickly see how a change to one artifact, for example a business objective, impacts others, like requirements, user stories, visual models, and tests. When change happens, Blueprint and Storyteller help you understand its impacts easily, reducing risk and rework.Learn More
Many requirements are common across an organization. Blueprint and Storyteller provide requirements reuse capabilities that enable pharmaceutical organizations to define these requirements once and use them across projects and teams to speed delivery, improve quality, and reduce risk.Learn More
Blueprint’s Agile requirements product, Storyteller, automatically generates user stories, acceptance criteria, and tests from collaboratively-defined process models, eliminating manual data entry, improving quality and consistency, and speeding delivery. It also synchronizes this information with other ALM solutions, including many of the leading Agile task management tools and the Blueprint QAS Solution for test management, seamlessly keeping development teams up-to-date.Learn More
Blueprint boosts adoption across your organization by supporting our enterprise-ready software platform with a Customer Success Manager, eLearning options, professional services, end user support, and a robust partner ecosystem to ensure success. We are here to help you succeed.Learn More