🚀💻Future-proof your regulatory strategy with advanced Regulatory Information Management solution (RIMS) designed for the evolving pharma landscape. #regulatoryinformation #realtimecompliance #scriptalldna #pharma #pharmaindustry #pharmatech #manufacturingexcellence #scalability #customsoftware #softwareforpharma #pharmsoftware #bespokesoftware #softwareinnovation #techinpharma #manufacturingtech #dataintegration #datacompliance #compliancemanagement
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Do you know the difference between ISPE's maturity models and which one will work best for your pharma operation? Check out this article to get familiar with ISPE's Data Integrity Maturity Model and Pharma 4.0 Maturity Model. 👉 https://azzur.co/4bTh7vk #Pharma #DataIntegrity #Compliance
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Do you know the difference between ISPE's maturity models and which one will work best for your pharma operation? Check out this article to get familiar with ISPE's Data Integrity Maturity Model and Pharma 4.0 Maturity Model. 👉 https://azzur.co/4bTh7vk #Pharma #DataIntegrity #Compliance
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The FDA’s recently updated guidance on “Benefit-Risk Assessment for New Drug and Biological Products” represents a significant shift towards a more patient-centric approach. Staying ahead of regulatory changes like this one is crucial for success, which is why we've put together an article that explains: - What the guidance means for pharma companies - How to implement the guidance - Challenges and opportunities https://hubs.la/Q02N86d50 #FDA #Compliance
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Your regulatory department is only as effective as your Documentation Management. In the pharmaceutical industry, regulatory compliance hinges on effective documentation management. A regulatory department can only support buisness decisions effectively if they can quickly assess any change against the dossier. Key Points: Traceability and Transparency: Essential for audits and maintaining stakeholder trust. Documentation must be organized and accessible. Efficiency: Quick access to necessary documents speeds up business decisions. Document harmonisation allows easier change management. Risk Management: Proper documentation managment identifies and mitigates risks. Gaps in the data can be identified if the dossier can be viewed holistically. Knowledge Preservation: Captures crucial development insights, facilitating future innovation. Understanding the history of your dossier is essential for buisness continuity and change assessments. Learn from your past submissions. Investing in robust documentation management isn't just about meeting regulatory requirements; it's about leveraging information for competitive advantage and ensuring patient safety and product quality. #PharmaceuticalRegulation #DocumentationManagement #RegulatoryCompliance #regulatoryaffairs #pharmaceutical #gmp
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🌐 Join us for a virtual Pharma Regulatory roundtable 🗓 Date: Tuesday, 1 October 2024 🕟 Time: 4:30–5:30pm (CEST) The life sciences sector is rapidly evolving. Staying informed about regulatory changes is crucial. Our roundtable will help you navigate the regulatory landscape and seize strategic opportunities. 🔗 Register today and ensure you don’t miss out on this valuable opportunity! #Pharma #Regulatory #LifeSciences #VirtualRoundtable #IndustryInsights
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You can’t meet regulatory requirements in the pharmaceutical and healthcare industries without data integrity. Regulatory agencies set strict guidelines to ensure products meet the necessary standards for efficacy and safety. To meet compliance standards, data integrity requires: * Accurate Data Collection * Secure Data Storage * Audit Trails * Transparent Reporting Are you missing the target on data integrity? Find out here. https://cc94.co/3T6rYf6 #lifesciences #compliance #dataintegrity
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Director of Customer Relations @ CfPIE | Etiquette Consultant/Owner @ Social Graces of the Main Line
You can’t meet regulatory requirements in the pharmaceutical and healthcare industries without data integrity. Regulatory agencies set strict guidelines to ensure products meet the necessary standards for efficacy and safety. To meet compliance standards, data integrity requires: * Accurate Data Collection * Secure Data Storage * Audit Trails * Transparent Reporting Are you missing the target on data integrity? Find out here. https://cc94.co/3T6rYf6 #lifesciences #compliance #dataintegrity
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🌐 Join us for a virtual Pharma Regulatory roundtable 🗓 Date: Tuesday, 1 October 2024 🕟 Time: 4:30–5:30pm (CEST) The life sciences sector is rapidly evolving. Staying informed about regulatory changes is crucial. Our roundtable will help you navigate the regulatory landscape and seize strategic opportunities. 🔗 Register today and ensure you don’t miss out on this valuable opportunity! #Pharma #Regulatory #LifeSciences #VirtualRoundtable #IndustryInsights
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Thanks a lot for sharing your insights, Gareth M. and Paul Attridge! I had been a proponent of decentralised data entry for many years, but due to the complexity of entering and maintaining data in line with both system requirements and increasingly demanding regulatory requirements such as IDMP, I have seen that a decentralised approach often leads to a steady decline in data quality. Why? Because although your ‘local strategists’ know their data best, they might not be familiar with all the system and regulatory requirements necessary for correct data entry and maintenance. Yes, they can be trained. But keeping up with these ever-evolving requirements is time-consuming and can be frustrating for people already snowed under with their day-to-day activities such as preparing regulatory submissions and interacting with regulators. So, what often happens is that people start entering data inconsistently and not in line with the requirements, and data quality decreases steadily. Over time, users start getting frustrated with the system because they can no longer rely on it due to poor data quality. For example, reports are incomplete because people use different fields for the same data elements, and data submissions fail due to validation errors. I still believe that using a decentralised approach has many benefits, but it can only be successful if robust data quality controls are in place. Therefore, I really like the idea of a hybrid approach and would be interested in more information on how responsibilities are divided between your central team and local strategists.
Gareth M. from Jazz Pharmaceuticals shares insights and data models to optimize regulatory operations and manage submissions. Highlights include: • Balancing expertise and efficiency in regulatory data management • Embracing a data-centric, growth mindset for operational agility • Mitigating risk and increasing cost efficiency Read more: https://lnkd.in/enpAMvpq #IDMP #Regulatory #Pharma
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You can’t meet regulatory requirements in the pharmaceutical and healthcare industries without data integrity. Regulatory agencies set strict guidelines to ensure products meet the necessary standards for efficacy and safety. To meet compliance standards, data integrity requires: * Accurate Data Collection * Secure Data Storage * Audit Trails * Transparent Reporting Are you missing the target on data integrity? Find out here. https://cc94.co/3T6rYf6 #lifesciences #compliance #dataintegrity
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