Digital Solutions: Our Services
For the last two decades, Sequence has provided critical expertise in configuration and compliance of digital systems to our clients.
Working with Sequence to Implement your Digital Solution
Digital solutions are transforming the pharmaceutical manufacturing industry at a faster rate than ever before. Newer solutions leverage data analytics, artificial intelligence (AI), machine learning (ML), Internet of Things (IoT), and other technologies to improve efficiency, quality, and safety in pharmaceutical manufacturing.
The adoption of these technologies is expected to continue to accelerate in the coming years as the industry seeks to increase efficiency, productivity, and agility. This makes it critical to choose a partner who is well-versed in the latest industry trends such as Pharma 4.0, digital twin, and Computer Software Assurance (CSA).
Our consultants take a lean, risk-based approach to ensure that your digital systems are qualified for intended use, by working with you to implement a compliant system that is easy to maintain, scale and integrate. Whether you need help with platform selection, creation of an Electronic Batch Record (EBR) or a Control Chart for Continued Process Verification (CPV), Sequence has you covered.
As technology continues to evolve, and regulatory agencies are continuously updating their guidance and regulations, we will guide you through system selection followed by implementation and integration of a digital solution that meets your business objectives in a compliant and secure manner.
Areas of Focus
- Cell & Gene Therapy
Manufacturing Execution System
Manage, optimize and control your manufacturing process with real-time monitoring and control of critical process parameters to improve your production process and ensure consistent product quality. This includes production scheduling and planning, recipe management, materials management, downtime management, and performance analysis and reporting.
Learn about the benefits of working with Sequence to implement your company’s Manufacturing Execution System (MES)
An MES can help streamline and automate your manufacturing process, reducing cycle times, and improving productivity. It can also eliminate manual data entry errors and improve data accuracy, reducing rework and waste.
An MES can help enforce process controls and reduce the risk of human error, improving product quality, and reducing the risk of quality incidents.
Better visibility and control
An MES provides real-time data and analytics, to allow for better decision-making and provides greater visibility into the manufacturing process. It also allows for better tracking and tracing of products, improving compliance with regulatory requirements.
An MES can help you quickly adapt to changing market conditions and production requirements, enabling you to respond faster to customer demands and market changes.
An MES can help improve collaboration and communication between different departments, such as manufacturing, quality, and supply chain, enabling better alignment and coordination.
Distributed Control System (DCS)
Control and monitor various manufacturing processes from a central location through a network of sensors, controllers, and actuators distributed throughout the production area, connected to a central control system. The DCS typically involves a network of interconnected devices, sensors, and controllers that work together to manage and optimize the manufacturing process and provides you with control and real-time monitoring of critical parameters such as temperature, pressure, flow rate, and pH, allowing operators to maintain governance of the manufacturing process and ensuring product quality and consistency.
Learn more about the benefits of working with Sequence to implement your Distributed Control System (DCS) for project success
Improved process control
A DCS provides real-time monitoring and control of critical process parameters, enabling you to maintain tight control over the production process and ensure product quality and consistency.
A DCS can help identify and respond to safety hazards quickly, reducing the risk of accidents and ensuring a safe working environment.
Increased control and efficiency
A DCS provides a graphical interface for ease of use that production teams can leverage outputs from to help automate and optimize the manufacturing processes, reducing cycle times, and improve overall productivity.
A DCS increases reliability and reduces installation costs by localizing control functions near the process plant, with remote monitoring and supervision.
Manufacturing Intelligence System (MIS)
Collect and analyze real-time production data for a centralized view of production performance that will enable you to make better-informed decisions about how to optimize production processes, improve quality control, and reduce costs. When implemented properly, the system will allow you to integrate data from a range of sources, including manufacturing equipment, distributed control systems (DCS), manufacturing execution systems (MES), enterprise resource planning (ERP) systems, historians and laboratory systems.
Learn more about the benefits of working with Sequence to implement your Manufacturing Intelligence System (MIS)
Manufacturing Intelligence systems can help to improve the efficiency of the production process by providing real-time data and analytics on production performance, so you can identify and resolve production bottlenecks and inefficiencies more quickly.
Better decision making
With access to real-time data and analytics on production performance, you’ll be able to make better-informed decisions about how to optimize production processes (golden batch), improve quality control, and reduce costs.
Manufacturing Intelligence systems provide a centralized view of production data, so you can monitor production processes in real-time, identify trends, and detect issues before they become problems.
Improved quality control
By providing real-time data and analytics on production performance, Manufacturing Intelligence Systems can help to improve quality control allowing you to identify and resolve production issues more quickly, reducing the risk of product defects and improving the overall quality of the products produced.
Access to real-time data and analytics on production processes can help to reduce downtime by enabling you to detect and resolve issues quickly, improving the overall efficiency of the production process.
In pharmaceutical manufacturing, data analytics can be leveraged to improve production processes, increase efficiency, and reduce costs. Data is typically collected from various sources, including manufacturing equipment, distributed control systems (DCS), manufacturing execution systems (MES), enterprise resource planning (ERP) systems, historians, laboratory systems, sensors, and quality control systems and uses advanced analytics tools to analyze this data in real-time.
Find out more about the benefits of working with Sequence to leverage data analytics as a part of your digital solutions
Data analytics can be used to predict equipment failures and schedule preventive maintenance, reducing downtime and increasing equipment reliability.
Data analytics can be used to monitor and control critical process parameters, enabling real-time quality control and reducing the risk of errors.
Data analytics can be used to analyze production performance data, identifying trends, and opportunities for improvement.
Supply chain optimization
Data analytics can be used to optimize supply chain processes, including inventory management and procurement, reducing costs and improving efficiency.
Data analytics can be used to generate compliance reports, ensuring that products meet regulatory requirements and quality standards.
The collective expertise of our team has allowed us to develop strategies for enterprise software solutions and planning for the development of custom digital solution services that are followed by successful project execution and FDA licensure. We work with some of the largest pharmaceutical corporations in the world. Let Sequence support your company’s project with meaningful digital solutions for your business success.
Frequently Asked Questions about our Digital Solutions
How is Pharma 4.0 changing the pharmaceutical industry?
Pharma 4.0 refers to the fourth industrial revolution in the pharmaceutical industry, characterized by the integration of advanced technologies such as artificial intelligence, the Internet of Things (IoT), and digitalization into the production and supply chain processes.
Pharma 4.0 is considered important to the future of the pharmaceutical industry because it has the potential to bring significant benefits to a company, including:
Increased efficiency and productivity: By integrating advanced technologies, Pharma 4.0 can help streamline production processes, reduce waste, and increase efficiency, leading to reduced costs and increased productivity.
Improved quality and patient outcomes: With the use of advanced technologies, such as predictive analytics and AI, Pharma 4.0 can improve the accuracy and efficiency of quality control processes, leading to higher-quality products and improved patient outcomes.
Enhanced supply chain management: By using IoT and digitalization, Pharma 4.0 can provide real-time visibility into the production and supply chain processes, allowing for more effective management and optimization of the supply chain.
Improved regulatory compliance: With the use of advanced technologies, Pharma 4.0 can help ensure regulatory compliance by automating documentation and record-keeping processes and providing real-time monitoring of production processes.
What are some of the latest digital solutions trends in the pharmaceutical industry?
Digital solutions in pharmaceutical manufacturing refer to the use of technology to optimize and automate various processes involved in drug development, production, and distribution. These solutions leverage data analytics, artificial intelligence (AI), machine learning (ML), Internet of Things (IoT), and other technologies to improve efficiency, quality, and safety in pharmaceutical manufacturing.
Digital solutions are transforming the pharmaceutical manufacturing industry, improving efficiency, quality, and safety while reducing costs and cycle times. The adoption of these technologies is expected to continue to accelerate in the coming years as the industry seeks to increase efficiency, productivity, and agility. A creative digital solution for your business can include:
Electronic Batch Records (EBRs): EBRs digitize the batch records, eliminating the need for paper records, and providing real-time access to batch data to enable faster and more accurate decision-making.
Process Analytical Technology (PAT): PAT involves the use of sensors and data analytics to monitor and control the manufacturing process in real-time, ensuring product quality and consistency.
Digital Twin: Digital Twin involves the creation of a virtual replica of the manufacturing process, enabling the testing of various scenarios and the optimization of the process before actual production.
Supply Chain Management Solutions: These solutions use data analytics and IoT to track and monitor the supply chain, enabling better inventory management, demand forecasting, and supply chain optimization.
Quality Management Systems (QMS): QMS digitizes quality processes, such as deviation management, CAPA (Corrective and Preventive Action) management, and change control, improving compliance, and reducing the risk of quality incidents.
Virtual Reality (VR) and Augmented Reality (AR): These technologies are being used in training and development programs for operators and technicians, enabling them to learn and practice various procedures in a safe and controlled environment.
What is the difference between Computer Software Validation and Computer Software Assurance?
Computer Software Validation (CSV) and Computer Software Assurance (CSA) are two separate but related concepts used in the pharmaceutical industry to ensure the quality and reliability of computer software used in the production of pharmaceutical products.
The main difference between the two is:
Computer Software Validation (CSV): CSV is the process of demonstrating that computer software solutions meet their intended use and specification and are suitable for its intended purpose within a business. It involves testing the software to ensure that it operates as expected, and that it meets regulatory requirements such as 21 CFR Part 11.
Computer Software Assurance (CSA): CSA is a broader concept that encompasses all activities related to ensuring the quality and reliability of computer software. It includes not only validation activities, but also activities such as risk management, change control, and software maintenance.
What is the difference between a Distributed Control System and a Manufacturing Execution System?
A Distributed Control System (DCS) and a Manufacturing Execution System (MES) are two different types of systems used in the pharmaceutical industry to manage and control production processes.
The main difference between the two is their scope and focus:
Distributed Control System (DCS): A DCS is a centralized control system that oversees and manages all automated processes in a production facility, including process control, instrumentation, and machinery. It monitors and controls production processes in real-time and provides detailed performance data for analysis and decision-making.
Manufacturing Execution System (MES): An MES is a specialized system that focuses on managing and controlling the production processes of a specific product, from raw material to finished product. It provides real-time monitoring and control of the production process, enables the collection and analysis of production data, and supports compliance with regulatory requirements.
How does a Manufacturing Intelligence System differ from a Manufacturing Execution System?
A Manufacturing Intelligence System (MIS) and a Manufacturing Execution System (MES) are two different types of software systems used in the pharmaceutical industry. While both systems are used to manage and optimize production processes, they differ in their purpose and function.
A Manufacturing Execution System (MES) is a software system that is used to manage and control the day-to-day operations of a production process. MES provides real-time data and control over the production process, enabling companies to monitor production performance in real-time and make adjustments as needed. The primary focus of an MES is on the execution of production processes and ensuring that the production process runs smoothly and efficiently.
A Manufacturing Intelligence System (MIS), on the other hand, is a software system that is used to collect and analyze production data to provide organizations with a centralized view of production performance. The primary focus of an MIS is on providing data and analytics that can be used to make better-informed decisions about how to optimize production processes, improve quality control, and reduce costs. An MIS provides a higher level view of production performance, enabling organizations to monitor and analyze production trends and identify production inefficiencies.
In summary, a Manufacturing Execution System (MES) is a software system that is used to manage and control the day-to-day operations of a production process, while a Manufacturing Intelligence System (MIS) is a software system that is used to collect and analyze production data to provide organizations with a centralized view of production performance and make better-informed decisions.