The standard for regulatory excellence keeps rising, and the government is under increasing pressure to do more with less. Factors driving this trend include the rapid globalization of supply chains and the expansion of data sources. In addition, budget pressures have forced regulatory agencies to make more decisions with less resources.
While regulatory professionals are facing an increasingly complex landscape, they are not without solutions. The proliferation of information sources and heterogeneous data makes the task of obtaining and analyzing information difficult. Additionally, traditional information management approaches were not designed to cross organizational boundaries. For example, regulatory document creation is not a discrete activity, but rather must be viewed as an enterprise-wide process that benefits all departments.
Regulatory information management software can be a powerful tool in this context. It can streamline the compilation, routing, review, and approval of regulatory content. It can also centralize data and content, enabling the streamlined management of applications and regulatory processes. Regulatory operations software can also streamline collaboration and improve workflow efficiency.
The life sciences industry faces a myriad of challenges - declining blockbuster drugs, generic competition and global economic downturn. To combat these challenges, life sciences organizations must embrace OpEx (Operational Excellence). With this in mind, a Regulatory Information Management (RIM) system can help companies achieve operational excellence.
As a result, pharma companies are undergoing radical transformations to become more agile. Many are reengineering their key R&D processes and partnering with CDMO-CROs to outsource some key development activities. However, these transitions must not be hindered by the burden of complex regulatory information management paradigms.
Regulatory information management is an essential part of the quality management system. It must be managed across the organization and its partners, and processes must be in place for deviations, internal audits, and complaints. It can also help organizations automate workflows by creating interactive dashboards and reports. The data collected can be used for continuous improvement.
Regulatory information management is critical for a company's quality mission, but it can also be used as a strategic management tool. To be effective, regulatory information management should be aligned with other business objectives, such as the improvement of customer satisfaction and operational excellence. To do this, the company must invest in operational excellence initiatives that link quality systems across the supply chain. Once these initiatives are well-integrated into the quality function, executives will have a better line of sight and reduce the burden of regulatory inspections.
As a result of the new competitive landscape, regulatory organizations must also invest in talent management. Whether it is a government agency or private sector organization, it must be able to demonstrate a compelling value proposition to prospective employees. Effective talent management strategies will augment regulatory information management modernization efforts, retain the best employees, increase organizational agility and earn a higher ROI.
- Operational Excellence FAQ: Why should you modernize regulatory information management in life sciences organizations?
- Challenges in Modernizing Life Sciences Regulatory Information Management Systems
- USFDA Guidance on Life Sciences Regulatory Information Management
- Economic Impact of Life Sciences Regulatory Information Management
- What are the drawbacks if Regulatory Information Management (RIM) of life sciences organizations is not modernized?
- How to Overcome Challenges in Life Sciences Regulatory Information Management
- Benefits of modernizing life sciences Regulatory Information Management
- Transitioning from Computer Software Validation (CSV) to Computer Software Assurance (CSA)
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Categories: Life Sciences | Operational Excellence
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#RegulatoryInformationManagement #RIM #lifesciences #continuousimprovement #operationalexcellence #continuousimprovementforlifescienceindustry