Life sciences companies operate at an accelerated pace. Rapid growth is necessary for success, and organizations are tasked with expanding and innovating quickly while keeping costs down. Streamlining business processes is an efficient way to keep operations lean while focusing on company growth and long-term objectives.
There are a number of critical processes that exist behind the scenes that form the backbone of operations. Understanding the language and acronyms involved with those processes, and how they relate to life sciences operations, is important for any company interested in operating more efficiently.
Here are some of those acronyms that life science firms should know.
Also known as a laboratory information system (LIS) or laboratory management system (LMS), the LIMS is a software solution designed to support laboratory operations. It handles a variety of processes including tracking workflow and data from samples, instruments and experiments. It can also manage laboratory informatics, automate lab workflows and tabulate QA/QC results.
LIMS solutions aim to improve productivity and efficiency and are dynamic by nature to meet the evolving demands of different types of laboratories. Life sciences businesses frequently adopt a LIMS to automate their workflows, reduce costs and improve the transparency of lab work status.
At the moment, many life sciences companies around the globe are relying on a LIMS to help fight the COVID-19 pandemic.
A QMS represents a variety of business processes, all designed to help businesses meet customer requirements and improve satisfaction. It encompasses a company's goals, policies, processes and strategic direction along with the information and resources required to implement and maintain those directives.
In the life sciences field, quality control is directly tied to innovation and growth. A comprehensive QMS solution is critical for getting new products to market quickly and efficiently Ideally, a QMS is designed to automate quality throughout the entire lifecycle of a product, and that ultimately accelerates time to market.
Important features and their benefits include:
Most QMS offerings are available on the cloud, and they support automated compliance and management of the processes outlined above. Digitized quality data is easily collected and integrated with other back-end processes to help drive change and improvements across an entire product life cycle as well as fuel company growth.
The practices necessary to conform to licensing and manufacturing guidelines, known as GMP, are vital in the life sciences industry. In the pharmaceutical space, they are also referred to as CGMP, or current good manufacturing practices. The guidelines spell out the minimum manufacturing requirements needed to ensure products consistently meet certain quality standards. They are meant to protect consumers and ensure products are free from contamination.
GMP also covers the documentation and training components of a product's lifecycle, as well as quality control. A QMS system will handle these requirements, ensuring good manufacturing, clinical and laboratory practices are being adhered to.
In the U.S., GMP commonly refers to regulations set by the Food and Drug Administration (FDA). They cover the design, monitoring and control of manufacturing processes and facilities, including operations. Life sciences companies can adhere by maintaining robust operating procedures, checking product quality deviations and maintaining reliable testing laboratories.
In addition to implementing a strong QMS system, a good LIMS solution is beneficial for adhering to GMP guidelines.
The MES is a digital system used to track and document the transformation of raw materials to finished goods in manufacturing. It includes information about how current conditions and processes may be optimized to improve production output.
MES typically works in real-time to control inputs, personnel, machines and support services throughout the production process. It manages everything from resource scheduling to production analysis to downtime tracking. By creating an "as-built" record, MES offerings capture the data, processes and outcomes across an entire manufacturing process.
A critical tool for life sciences companies, which often require documentation and proof of processes throughout a product life cycle, MES can operate as a stand-alone product or as part of an enterprise resource planning (ERP) solution.
ERP solutions sometimes feature integrated MES capabilities designed to improve production planning, scheduling and warehouse efficiencies. These integrations support process manufacturing orchestration and execution, enterprise performance management and quality management and compliance.
An ERP solution is perhaps the most powerful tool a life sciences company can employ. Designed to integrate the management of a variety of business processes, ERP solutions offer automation and integration of a variety of data, workflows and processes necessary to optimize business operations.
In addition to handling manufacturing execution, ERP helps life sciences companies navigate through each stage of the business. They provide value from the pre-revenue capital intensive stage of development through to clinical trials and onward to the rapid growth stage.
It is an exciting time to be involved in the Life Sciences industry with innovation happening at a breakneck speed. This pace of innovation in the industry is providing Life Sciences companies with both opportunities and challenges The accelerated pace of the life sciences industry requires a powerful set of tools to manage back-end processes. By understanding the importance of those processes and finding the right tools to automate and streamline them, businesses can speed their path to rapid growth and monetization.
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