Pharmaceuticals & Life Sciences
Industry Challenges
The advent of biologics, more widely distributed supply chains and the increasing complexity of industry regulations creates many challenges for modern Pharmaceuticals & Life Sciences manufacturers. Quality controls slow everything down. New drugs take longer to be developed, completed drugs take longer to get to patients and new technologies are much slower to be adopted. The focus on quality is expensive too, driving up costs for both manufacturers and patients. Operating within one of the most challenging and stringent regulatory environments of any industry, companies aiming to stay competitive and profitable must implement digital solutions that facilitate and quality-proof a meticulous adherence to quality standards and process controls.
Our Industry Solutions
1. Product Specification Management
Product Specification Management systems are designed to meet the unique data management needs of the life science industry's product design and manufacturing planning processes. Our Product Specification Management solutions cover all the processes used to develop, configure and manage product specifications, from raw materials to intermediate materials and all the way to the finished product and packaging. In addition, our solutions support formula management, a particularly critical process for pharmaceuticals, with features to create and configure formula variants, create and manage the workflows to make changes and manage labeling content.
- Product Specification Management
- Intellectual Property Management (Product & Methodology)
- Product Variation Management
- Formula & Recipe Management
- Laboratory Data Management
- Supplier & Internal Collaboration Tools
- Regulatory & Quality Data Management
2. Laboratory Information Management Systems (LIMS)
Our Laboratory Information Management System (LIMS) solutions enable companies to effectively manage laboratory and associated data in order to improve lab efficiency. An effective LIMS supports and drives a modern laboratory’s operations and enables Pharmaceuticals & Life Sciences leaders to automate workflows, integrate instruments and manage laboratory data and related information easily, quickly and reliably. Our LIMS solutions aim to make data and information easier to store, track and assess over time and across experiments, so that labs can continuously evaluate and improve their operational efficiency.
- Laboratory Sample Traceability & Management
- Laboratory Workflow Traceability & Management
- Laboratory Instrument & Application Integration
- Audit, Quality Assurance & Process Control
- Laboratory Document Management
- Laboratory Data Entry, Reporting & Management
- Cross-Department Electronic Data Exchange (Planning, Design, R&D, Manufacturing)
3. Manufacturing Execution Systems (MES)
Our end-to-end Manufacturing Execution System (MES) solutions manage and monitor all work-in-progress on a Pharmaceuticals & Life Sciences production floor, tracking all manufacturing information in real time, receiving up-to-the-minute data from robots, machine monitors and employees. Integrating top MES and Electronic Batch Recording (EBR) technologies to deliver cost-effective solutions designed for unique life science needs, our MES solutions maximize production capacity, optimize quality control processes and streamline operations across the production laboratory and even globally distributed sites.
- Production Order Management & Execution
- Detailed Production Scheduling & Planning
- Production Monitoring, Data Collection & Reporting
- Material Management & Genealogy (Tracking & Tracing)
- Quality Testing, Audit Trail & Electronic Signature
- Quality Management & Statistical Process Control (SPC)
- Integration to Third-Party Systems (LIMS, ERP, SPC, SCADA, etc.)
4. Electronic Batch Recording (EBR)
For each batch produced, Pharmaceuticals & Life Sciences companies are expected to document the entire process, from lab to label. In this way, they establish a Master Batch Record, or a trail of evidence showing that the process operated within pre-established parameters and that the product meets all specifications and quality attributes. Batch records are the foundation of quality control in life science and pharmaceutical manufacturing. The cost of compliance, the burden of paperwork and the risk of error can be reduced significantly with the use of Electronic Batch Recording (EBR) software.
- Electronic Batch Record Design & Execution
- Material & Lot Management
- Weighing & Dispensing Management
- Equipment Status Management
- Electronic Batch Review & Release by Exception
- Electronic Signature & Workflow Enforcement
- Alerts & Deviation Management
5. Digital Supply Chain (Tracking & Tracing)
Our Digital Supply Chain (Tracking & Tracing) solutions utilize integrated technologies to ensure the safety and quality of products that enter the market. These solutions enable enterprises to digitally serialize their products, then manage, access and exchange serialization data across the end-to-end supply chain with stakeholders and regulatory institutions. This means Pharmaceuticals & Life Sciences companies can monitor the flow of raw materials, components and final products as they progress through the supply chain and ultimately through distribution and into the hands of consumers.
- Item, Product & Batch Serialization / Aggregation
- Item, Product & Batch Tracing / Verification / Genealogy
- Real-Time Monitoring of Supply Chain Activities & Events
- Serialization Data Access, Management & Exchange
- Product Defect, Recall & Return Management
- Secure & Centralized Serialization Data Database
- Compliance Data Reporting to Government Systems
Engineering's Advantage
The Pharmaceuticals & Life Sciences industry has historically been characterized by a reluctance to change processes and adopt technology due to regulatory constraints and pressures. This approach has started to change in recent years, however, as the Food & Drug Administration (FDA) and international regulatory agencies have started to embrace innovation and increase data collection and reporting requirements. Engineering Industries eXcellence has been on the forefront of this transformation, guiding pharmaceutical and life science manufacturers and facilitating the adoption of digital technologies aimed at improving quality, reducing patient risk and increasing data transparency.
Fully Compliant Industry 4.0 Solutions:
- Government & Industry Regulations
- ISA-95
- GAMP 5
- GxP
- cGMP
- 21 CFR Part 11
- Annex 11, Volume 4, Eudralex
Interested in speaking to one of our Pharmaceuticals & Life Sciences experts? Contact us at info@indx.com.
