UL can assist at different stages of your compliance, quality and performance growth.
Life Sciences companies can reduce the likelihood of product approval delays by becoming more knowledgeable about regulatory requirements and the impact to their operations. UL partners with clients to ensure that their quality management systems, technology platforms, people readiness and product submission will meet the rigor of the regulators.
Preparation is essential for any audit because of the escalating complexity and overlap of global quality regulations. Failure to meet audit requirements can severely impact the company, causing delays in product launch. UL partners with companies to develop an inspection infrastructure, processes for hosting and responding to inspections, and education for individuals on how to respond to an inspection.
Companies need to educate their GxP workforce on the latest regulations, so they can apply these requirements into their daily processes and procedures. UL provides educational solutions that enables companies to deliver GxP knowledge across multiple regions consistently and efficiently.
Maintain a high level of quality as you scale up your operations and expand your product strategy globally
Many companies struggle to validate installed and cloud-based GxP applications (ERP, DMS, LMS, SCMS, QMS, etc). Our experienced team helps make your validation activities more efficient, as we help with planning, documentation, change management, governance, test scripts, user requirements specifications and more.
Many companies are seeking proven systems governance models, as well as IT validation best practices, for their GxP applications. Trust UL expertise to help build a governance model and validate your critical systems.
Regulators globally have recognized the quality and compliance risks that are caused by a lack of data integrity. UL experts can assess your organization’s current data integrity practices and processes, identify risks, deliver targeted education, and help you build improved, sustainable data integrity processes.
UL partners with clients to provide dedicated resources to support periodic quality audits for manufacturers and their suppliers globally.
Many Life Sciences companies conduct a series of adhoc QMS audits before they discover that only a solid audit infrastructure will improve quality for the long term. UL’s QMS Audit solution helps companies establish a sustainable audit process that delivers a measurable impact on quality and compliance.
Companies partner with UL to add risk management principles so that high quality is assured consistently. Taking a risk-based approach also helps companies conduct a more accurate root cause analysis and prioritize resources appropriately. Our experts also help companies establish risk management offices within their organizations.
Achieve and sustain compliance as you expand product lines and build your workforce
For many global Life Sciences companies, fast growth has resulted in an expansion of learning management processes and systems, impacting new product lines and new teams of employees. As companies grow, there is an impetus to create a systematic approach to learning and development that includes strategy & governance models, and a holistic perspective of the learning management infrastructure. UL works with clients to optimize their learning management processes, practices, content and systems.
As companies mature, they can be challenged by collecting and sharing critical data in multiple systems. UL helps companies harmonize multiple systems so that companies can better automate their processes, reduce system overlap, conveniently share data across the enterprise and achieve better results from their big data efforts.
Many companies struggle to build a role-based training matrix that ensures the right knowledge is being targeted to the right job functions. UL partners with companies to align job qualifications and knowledge assets, to ensure this matrix meets regulatory expectations. We refine role-based plans right down to specific SOPs, classroom events and other learning activities, which improves worker productivity and eliminates qualification redundancies.
Many Life Sciences companies organizations are taking extra steps to define and assess the skills of those working in the aseptic manufacturing area. Our hands-on consulting experts work alongside your QA, Training, HR and Operations teams to build a sustainable operational excellence program that is grounded in real-world success.
Sponsors and even CROs struggle to capture capture certification and qualification from clinical site personnel. UL’s Clinical Site Qualification Solution ensures higher quality during the trial, and also reduces the time spent on site initiation and site certification, by delivering and capturing both protocol and non-protocol activities based on each person’s role in the study.
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