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Life Science organisations are facing pressure to produce faster, while maximising quality in adherence to regulations. And R&D laboratories aim to optimise operations by improving efficiency through automation and collaborative advancement.
There are many regulatory bottlenecks slowing the process, but a Product Lifecycle Management (PLM) solution can help to overcome these specific pains. A collaborative platform for pushing ideas through optimises product development to launch successful products in a swift, streamlined manner. The application of agile methodologies streamline the entire R&D process and allows scientists to concentrate on their core work, the research.
Creation of potential errors and delays in the overall project time
Laboratory test data is used to build technical reports and stored within a document management system. But before conclusion-building can begin, collaboration tools enable users to distribute and collate the data. Next, this information is manually re-written and transferred to manufacturing and the supply chain.
The process of information management involves a lot of clerical work, which adds the risk of human error. And, as the information already exists, this doubles down on unproductive time.
PLM provides a single database to store data as a single source of truth and a common platform to access the data. It also provides enhanced search capabilities to find historical and older data so not data is lost.
Controlled, multi-user, secured access, updated with electronic signatures
You may previously have re-run costly experiments because of missing benchmark result data. And when data gets lost in expansive file-based storage systems, it can be almost impossible to locate.
The document-centric approach, which involves a lot of manual rework to maintain multiple versions of the same data, makes it impossible for global teams to reuse information and collaborate on product development.
PLM provides an organisational system with access at any time, for anyone in the organisation, along with a platform that enhances collaboration among teams and third parties to work seamlessly on real-time data.
Enable workflow and process management for communicating and approving changes
In Pharmaceutical compounds, a change in properties of one substance can impact multiple compositions. But in most cases, they only share this information through emails to a closed group of people. There are also no systematic processes set to review, approve, and communicate any changes throughout the company.
The lack of integrated workflow between multiple teams can cause flawed information spreading freely. PLM allows you to establish robust processes, approvals and standard operating procedures integrating all the departments and people in an organisation and adhering to set standards along with a platform supporting real time discussions and reviews.
Define item-focused task assignments through the creation of projects
When there’s no proper system in place to store the data systematically, project managers can lose track of the real time status of a project. And sites of a company are only up-to-date on the status of the project that is being carried out at the respective site.
Inadequate data availability gives managers poor visibility of their projects and prevents them from making prompt, informed decisions. PLM provides intuitive, real time dashboards for effective project tracking, calendars, schedule and deliveries management and improved decision making.
Identify materials content for environmental and other regulatory compliance
Pharmaceutical products, research, development and manufacturing processes must comply with multiple global and local regulations to reach the end user market. Pharma companies ensure that their products consistently comply with many regulations at the same time.
PLM allows organisations to track product compliance for different regulations simultaneously throughout entire product lifecycles and structure documents in adherence to regulatory compliances.
Work efficiently with Pharma-focused capabilities
Pharmaceutical products require focused data management and easy submission of documents to regulatory authorities to reduce the time to market, obtain authorisations and manage renewals or variations.
PLM provides organisations with pharma-focused capabilities to support clinical trials, storage and indications, medical dictionaries and definitions to expedite submissions and authorisations.
Adopting best PLM practises from other industries
Pharmaceutical companies are discovering the need to develop tools and processes for effective data management and collaboration. They require tools which can help them integrate products, processes and people seamlessly. And in the last few weeks we’ve seen cross-industry collaboration prove its effectiveness.
Many are choosing PLM tools to address their unique challenges. And these organisations are now more effective in the tracking of their organisational processes via a complete, accurate, up-to-the-minute dashboard of their organisation’s activities.
Dassault Systèmes have spent thirty years digitising objects and propose to digitise the health industry over the next twenty years.