- Registration is OPEN for the 7th Annual Sequence Charity Golf Tournament
Optimizing people, processes and timelines to deliver highly successful operations.
Optimizing people, processes and timelines to deliver highly successful operations.
Sequence provides comprehensive engineering consulting solutions for our life sciences clients to ensure that facilities and manufacturing processes are designed and tested to meet end user requirements. Leveraging deep process knowledge, our consultants provide valuable input to ensure compliance and efficiency from conceptual design through licensure to bring projects to life effectively and efficiently. Our expertise encompasses facilities, equipment, utilities, laboratory instrumentation, and computerized systems.
To help expedite your project timeline and get your facility production-ready, we offer a science- and risk-based CQV project plan, based on our industry knowledge that includes common project pitfalls and compliance best practices. Our proactive, hands-on approach allows us to anticipate issues before they arise, adjust quickly as project variables change and seamlessly adapt as projects become more complicated along the way. This results in a smoother overall project execution and reduced timeline to turn over a facility fit for intended use that is ready for inspection.
Our SMEs use a systematic approach of developing user- and functional- requirement specifications for facilities, utilities, processes, software and systems to ensure key components such as CQAs, CPPs, product knowledge, process knowledge and sequence of operations are defined to reflect desired functionality and intended use.
Whether you need support for an existing facility or a new one, our team of experts can develop and implement strategies to bring the full scope of your manufacturing and engineering project into a compliant state, by utilizing a science and risk-based approach (i.e. ASTM-e2500, ISPE Baseline Guidance, etc.) and quality-by-design concepts. Available strategies include:
Planning is critical when performing a risk-based CQV effort. Our team of experts will develop CQV plans (Site Validation Master Plan, Commissioning Plan, IT Validation, Lab Validation, Computer System Validation) based on industry standards and guidelines to cover the following components:
Sequence delivers comprehensive engineering solutions tailored to the unique needs of pharmaceutical manufacturers. We support our clients through every stage of facility start up and process development, ensuring compliance, efficiency, and innovation for highly regulated environments.
Our extensive knowledge and years of experience across the life sciences industry work as an insurance policy for your project execution. Whether you partner with us for your entire commissioning, qualification and validation project scope or require a more specialized solution, we offer proven strategies to help you achieve and maintain operational readiness that will bring your pharmaceutical products to market on time and on budget.
Sequence ensures that all computerized systems used in GMP-regulated processes are reliable, secure, and compliant with regulatory requirements like FDA 21 CFR Part 11. Our team understands how to ensure your data integrity, support product quality, and mitigate operational risks by verifying that systems function as intended.
Sequence offers comprehensive services to bridge the gap between business systems and manufacturing operations. These services are critical for deploying Manufacturing Execution Systems (MES), Management Information Systems (MIS), and Manufacturing Control Systems (MCS), enabling seamless data flow, improved compliance, and enhanced operational efficiency.
IT (Information Technology) is focused on business operations, data processing, and network infrastructure.
Sequence is uniquely qualified to support your project beyond startup, by bringing the ability to help ensure that all people, systems, processes, and facilities are fully prepared to begin safe, compliant, and efficient commercial operations.
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No Code App Development for Manufacturing Operations
Tulip creates user-friendly and functional apps that improve the productivity of operations, without writing any code. Users can start from scratch or customize an App Template to fit their needs.
Sequence partners with Tulip for implementation and validation of the Tulip platform as well as creation, configuration and validation of Tulip Applications that are hosted on the platform. Our application builds include Electronic Batch Records, Weigh and Dispense, Digital SOPs for training (with embedded videos) and more.
