Qualio’s Post

Regulations and ISO standards are a useful target for life science start-ups in their earliest days. But past a certain point, focusing on them too closely hinders rather than helps your business. It encourages line-by-line maintenance of the status quo, fixated on compliance rather than quality. Compliance is reactive, one-size-fits-all, and binary. Quality is proactive, unique to your business set-up, and a spectrum to move through. Compliance holds your business back to its bare minimum, stopping anything other than the foundations being built. Quality gives you the framework for continuous improvement and best practice to be pushed. It’s no surprise that the FDA found excessive focus on compliance to be a leading cause of drug shortages in the US. Make compliance your springboard, not your end goal.

Struggling to find life sciences professionals who grasp the intricacies of regulations and compliance Outsource SA is your gateway to expertise that goes beyond the surface. We identify visionaries who understand the regulatory landscape intricately. Our professionals are not just experts; they are the architects of your production excellence, optimizing manufacturing processes to meet the ever-evolving demands of the industry. Experience manufacturing excellence that aligns seamlessly with regulations! With Outsource SA, you'll have professionals who not only adhere to strict standards but also innovate and optimize, ensuring your production processes are at the forefront of industry demands. Optimize your manufacturing processes? Click the link below https://lnkd.in/dDJXvaWJ #OutsourceSA #LifeSciences #ManufacturingExcellence #RegulatoryCompliance #GMP #VisionaryLeaders #InnovateAndOptimize #ProductionExcellence

The High Costs of Quality Failures: A Cautionary Tale for Regulated Manufacturers I'll never forget the urgent recall from an auto client - lives at risk due to quality failure. We'd warned rushing innovative designs without rigorous validation would have consequences. Now those risks materialized into crisis. For over a decade, I've worked with regulated manufacturers to optimize quality protocols and cGMP standards - mandatory to prove safety and effectiveness. My specialty is finding root causes of issues and tailoring solutions to each environment. With the auto client, it took 2 years to transform their culture and processes to align with the highest standards. Significant investments to strengthen controls, retrain staff, upgrade analytics for real-time monitoring. Compliance became integral to all processes. Today, they have renewed consumer trust through perseverance. Though costs were severe, they learned and became leaders in safety. My proudest reward is knowing we helped save lives. It's never too late to course correct - we can guide any struggling manufacturer to cGMP excellence and sustainability.

3 training topics that should be part of every stage of drug development. 📒 Document management -Documents (whether electronic or manual) are the building blocks of every stage of development. Understanding the significance of these documents (SOPs, protocols, records, certificates, reports etc.)in regulatory approvals, compliance, consistency of operations, resolving conflict etc. is important for every individual in the organisation. 📊 Data management & Data integrity - Data is king in today's world. It's role and importance is only going to grow as the industry moves towards more & more digitalisation. To thrive in this data-centric environment, individuals must understand the intricacies of data types, controls & data process flows. They need to be aware of DI principles & how they impact approvals & continued compliance. Equip your teams with at least the basics of data integrity & good documentation practices. ⚡ Risk Management - Risks are part of every & any activity associated with drug development (some are direct risks to the product & some indirectly affect product quality/supply). Regulatory bodies globally are emphasisng the need for basing operational decisions on risk assessments. Training your staff on effective risk management is not just advisable but imperative. #qualitymanagement #compliance #training #gmp #drugdevelopment #pharmaceutical #lifesciences

It's fair to say that regulatory compliance poses one of the greatest challenges or pitfalls for manufacturers in the Software in Medical Devices (SiMD) supply chain. Compliance with regulations such as FDA guidelines can be intricate and demanding, requiring meticulous adherence throughout the supply chain process. Failure to comply can result in severe consequences, including regulatory penalties, product recalls, damage to reputation, and legal liabilities. Therefore, ensuring regulatory compliance is paramount for manufacturers operating in this space. Ensuring regulatory compliance in the Software in Medical Devices (SiMD) supply chain is complex due to stringent FDA requirements. Key challenges include: Regulatory Complexity: Navigating FDA guidelines like 21 CFR Part 820 and Part 11 requires continuous monitoring and understanding. Documentation and Traceability: Maintaining accurate documentation amidst global supply chains poses challenges in demonstrating compliance. Compliance Verification: Ensuring suppliers, components, and processes adhere to regulations demands robust verification and transparency. Change Management: Managing changes while maintaining compliance necessitates careful planning and validation to avoid disruptions. Regulatory Updates: Staying updated with evolving regulations and standards demands proactive engagement. To mitigate these challenges: Regulatory Intelligence Gathering: Establish mechanisms to monitor regulatory updates and engage with relevant authorities and forums. Comprehensive Documentation Management: Implement robust document control systems and electronic solutions for streamlined processes. Supplier Compliance Assurance: Develop auditing programs for supplier compliance and prompt resolution of non-conformities. Change Control Processes: Formalize change control procedures with risk assessments and approvals. Continuous Training: Provide ongoing training on regulatory requirements and best practices. Regulatory Liaison: Foster relationships with regulatory bodies to influence policy and stay informed. Internal Audit and Monitoring: Conduct regular audits and implement surveillance systems for compliance detection. Risk-Based Compliance Management: Prioritize efforts based on risk assessments to mitigate vulnerabilities effectively.

Regulation is critical to governing manufacturing processes and ensures the safety of products. While no one would deny the importance of regulations, they can make it difficult to adjust to an ever-changing business environment. This article explores how businesses can balance the need to maintain regulatory compliance while maintaining the ability to adapt to challenges.

Struggling to balance accuracy with #compliance? #WDMS from #ProcessXE offers a seamless solution that integrates precision #weighing with robust #regulatory adherence. #SarjenSystems #PharmaManufacturing #Manufacturing

𝗥𝗲𝗮𝘀𝗼𝗻 #𝟯𝟳 𝗪𝗵𝘆 𝗙𝗿𝗮𝗰𝘁𝗶𝗼𝗻𝗮𝗹 𝗤𝗔 𝗦𝗲𝗿𝘃𝗶𝗰𝗲𝘀 𝗠𝗮𝗸𝗲𝘀 𝗦𝗲𝗻𝘀𝗲: Upon its long-awaited launch, QMSR addressed many questions that had plagued industry for years. It also left some questions unanswered and raised new questions as to how future revisions to ISO 13485 will affect QMSR. So as manufacturers grapple with interpreting the new regulation, industry expects to see a huge upswing in the number of regulatory consultants needed to manage compliance. QMSR did close the gap on quite a few discrepancies between QSR and ISO 13485, but when ISO changes again - and it will - manufacturers will still have to juggle compliance between TWO standards. Which is the very thing this QMSR was designed to eliminate. Flipping back and forth between13485 and QMSR to find the the differences and the similarities can be time consuming and headache-inducing. So hiring someone who speaks fluent QMSR - even for the short term - can reduce your stress levels and streamline your quality processes. So give us a call. Life's too short to struggle unnecessarily. ------------------------------------------------------------------------------------ Hi - I'm Michelle, and I believe that a strong regulatory strategy can be a huge competitive advantage – and quite possibly fun to develop.  So if you're tired of dealing with regulatory submissions, audit preparation and remediation, due diligence, quality systems, and more, break out the tequila and give me a call! 🍸  #medicaldevices #regulatoryaffairs #compliance #FDA #startups #510k #medtech #biotech #submissions #qualitymanagement

Navigating the complexities of compliance in the #pharma industry can be challenging. But what if you had a partner with over two decades of experience, ensuring your systems meet all regulatory requirements seamlessly?     With our expertise, we offer more than just compliance – we offer peace of mind.      Imagine derisking your operations, eliminating any business disruption due to quality issues. Picture yourself focusing your time and effort on what truly matters, knowing that your systems are in safe hands.     So, why leave compliance to chance? Let us be your trusted partner in ensuring your systems are fully compliant, every step of the way. Check out our solutions page for more insights on how we can help you achieve regulatory excellence.  🤝    Link in the comments 🔗    #DigitalHealth #QualityEngineering #QualityAssurance