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    Frequently Asked Questions about Scilife’s Smart Quality Platform

    Scilife Frequently Asked Questions about the Smart Quality Management Software

    FAQs 

     

    Scilife is the first Smart Quality Platform for Life Sciences. We help people and organizations streamline quality management, automate processes, and transform quality into a company’s brightest asset. This moves quality beyond being a mere regulatory requirement and reframes it as a competitive advantage.

    By focusing on quality culture and capabilities, organizations can power rapid quality progress and ensure performance improvement. The ultimate impact? Improving patients’ lives.

    Find out why quality leaders rave about Scilife: Meet our customers!

    Scilife brings clarity to quality and compliance by fusing powerful quality management tools with advanced analytics, enhanced learning, and gamification. This comprehensive approach empowers you to…

    • Streamline Workflows: Immerse yourself in the seamless automation of quality processes such as CAPAs, change control, and document approvals. Reduce manual tasks, enhance efficiency throughout your organization, and transform quality management into a captivating journey for all team members.
    • Simplify Compliance: Achieve effortless adherence to industry standards and regulations with Scilife's bespoke features, meticulously engineered to simplify compliance processes and cater to your organization's unique needs.
    • Manage Risk: Identify, assess, and manage potential risks, ensuring that your organization is prepared to deal with any unexpected regulatory changes or non-compliance issues.
    • Continuous Improvement: Promote a culture of continuous improvement, helping your organization to not only maintain compliance but also to improve processes and products continuously.
    • Measure and Optimize: Harness the potential of comprehensive analytics and data-driven insights to identify areas of improvement, monitor emerging trends, and make well-informed decisions that drive quality enhancement throughout your organization.

    Intrigued? Access core features with the Scilife Free Plan.

    Smart Quality is a brand-new approach to traditional Quality. Its core aim is to empower everyone in the organization to take real ownership of quality, reduce compliance risk, and ultimately, achieve peak performance. 

    How? By implementing and combining improved quality tools with advanced data analytics, personalized continuous learning, and gamified methodologies. 

    Our Smart Quality vision is infused in each and every detail of the platform and has been carefully designed to help your organization reach Smart Quality as effortlessly as possible. 

    We’re here to be your true Life Science ally - helping you go paperless, engage everyone with Quality processes, get lean by improving your process workflows, and reduce costs while generating business value. 

    Scilife merges design-thinking, gamification, and continuous learning with dynamic quality management tools and insightful data, to help Life Sciences organizations accelerate time to market by more than 30 percent and reduce their total cost of quality assurance by up to 50 percent – thereby reducing the compliance burden and releasing key business resources to focus on higher-value tasks. 




    We’ll let the numbers speak for themselves…

     

    +50% 

    Improvement in quality metrics 

     

    +50-100%

    Increase in productivity and speed in quality control 

     

    +30% 

    Time to market improvement 

     

    +50% 

    Total cost of quality assurance reduction 

     

    -80% 

    Deviations and non-conformances reduction

    Smart Quality infuses Quality ownership into everyone’s daily tasks throughout the entire company. Rather than offloading Quality into a siloed QA department, it becomes all team members’ responsibility. Continuous improvement and massive value creation are the end result. 

    To help companies like yours achieve this, we´ve created three core pillars to promote quality: 

      • Insightful data

    Make sure you reach your business goals by making data-driven decisions. How? With Scilife Advanced Analytics. You’ll get the right information, at the right time, with custom reports, benchmark industry averages, and detailed visual data, so you can always see how you’re doing against your goals and where you need to take action. 

      • Enhanced learning

    Engaging other colleagues outside the QA department to get involved with Quality is not always easy. The Scilife Academy opens the door to both QA and non-QA roles to stay on the path of continuous improvement, with free access to video courses and certifications, to stay always up-to-date with Quality insights. 

      • Sustained motivation

    Struggling to encourage other departments to perform Quality tasks? Easily engage them with Scilife Gamified features: Scilife Scoring System, a more enriching training creation experience, weekly Quality Quizzes, the possibility to earn badges, and a leaderboard to keep track of personal and team performance. Everything you need to motivate all employees to complete trainings on time, deepen their quality knowledge, and take responsibility for their quality actions. 

    Scilife's Smart Quality Platform is designed specifically for Life Sciences industries, including pharmaceutical and biotech, medical devices, medicinal cannabis, CRO/CMOs, ATMPs companies, and other regulated organizations. Experience a solution tailored to your unique needs. 

    We’re ready to answer your questions, big or small: Get in touch!

    • Inefficient manual processes: Scilife automates quality management tasks, reducing the need for manual data entry and minimizing human errors. This leads to more efficient and accurate processes.
    • Inconsistent data: By centralizing all quality-related information, Scilife ensures that every stakeholder in the organization has access to consistent, up-to-date data, reducing the risk of miscommunication and errors.
    • Difficulty traceability and compliance: Scilife provides real-time visibility into your organization's compliance status, making it easier to monitor and maintain regulatory compliance.
    • Poor risk management: By helping you identify, assess, and manage potential risks, Scilife enables your organization to proactively address issues before they become serious problems.
    • Inadequate training management: Scilife streamlines the process of managing and tracking employee training, ensuring that your workforce is well-informed and up-to-date on compliance requirements.
    • Limited collaboration and silos: Scilife fosters collaboration and communication between departments, teams, and individual employees, ensuring that everyone is on the same page when it comes to quality management.

    Scilife is entirely cloud-based. It requires no hardware installation, physical storage space, or in-house maintenance. Your data is secure and backed up at all times by AWS cloud technology. Scilife also comes with out-of-the-box functionality that serves 80% of the Life Sciences industry’s needs. It’s a one-size-fits-all solution for Life Sciences companies of any size. 

     

    Ensures inspection readiness 

    In such a highly regulated environment, it’s vital to be ready for audits at all times. Risk assessment is infused into our platform, so you can rest assured knowing you’ll have a spotless audit trail at any time. From risk-proof design to effective implementation of CAPAs, to compliant e-signatures and approval workflows, to painless assignment and follow-up of compliance trainings. Everything is transparent and traceable, at all times. 

     

    Easy for everyone 

    Our Scilife user-centered interface is simple, intuitive, and browser-based.
    This makes the Scilife platform accessible from anywhere, by anyone, and really easy to learn. 

     

    Cultivate a Quality-Driven environment

    A robust, dynamic culture forms the foundation of any thriving organization. Our comprehensive approach centers on fostering a setting where quality is embraced, enabling teams to pursue excellence with confidence. 

    Hundreds of leading life sciences companies worldwide like Novartis, Biocartis, Yusen Logistics, Polpharma, Pendulum, and many more trust Scilife to manage their quality processes, empower employees to take quality ownership, enhance efficiency and transparency, and reduce compliance risk.




    At Scilife we offer different plans to cover every company’s needs according to the size and industry, whether you’re starting out small or operating at an enterprise level. 

     

    Smart Quality Management System: 
    • Document Control Management 
    • Record Management
    • Trainings Management 
    • Competences Management 
    • Quality Process Designer 
    • Quality Events Management 
    • CAPAs Management 
    • Change Control Management
    • Audits Management
    • Risk Management
    • Equipment Management
    • Advanced Analytics/KPIs 
    • Management Supplier Management
     
    Product & Process Development 
      • Design & Development (D&D) 
      • Quality by Design (QbD) 

    Controlled Print and Reconciliation 

    Scilife helps you stay fully compliant with all the required regulations: 

    Good Manufacturing Practice (GMP) 

    Good Distribution Practice (GDP) 

    Good Laboratory Practice (GLP) 

    Good Clinical Practice (GCP) 

    Good Tissue Practices (GTP) 

    GAMP 5

    FDA 21 CFR PART 11

    EU ANNEX 11 

    ISO 13485 ISO 14971 ISO 15189 

    ISO 17025 

    Scilife uses a system validation approach on the hosted platform, lifting 95% of the validation burden off the shoulders of our customers. 

    Scilife uses a GAMP5 validation approach for validating the system on the Amazon Web Services (AWS) platform. As part of the validation phase, the Scilife platform is validated for, e.g., standard functionality and workflows in an environment independent of customers. This validated environment for standard functionalities and workflows can be used as-is by our customers, if their business process is aligned with the Scilife platform default workflow. The validation package includes a drafted, executed, and signed-off validation documentation set that customers can use as the basis for the validation of Scilife on their end. All showcased options are risk-based approaches. This document effectively eliminates most of the costs and resources needed for validation by our customers.

    Scilife has implemented a complete validation for the SaaS platform on the AWS platform. The platform has been developed following regulatory requirements, being fully validated by us according to GAMP/21CFR11. 

    Check this article for more information about Scilife validation process. 

    Integrations like MS Active Directory or AzureAD are not a problem at all. Besides that, Scilife is API-driven. Its RESTful API makes it very easy to integrate with other systems.

    No. As a cloud based solution it is impossible to have Scilife managed anywhere other than the cloud data centre. If you wish to have data on site, you can avail of our 'Read Only' data access, whereby you will be able to access your data in the cloud, download it and keep these records at your physical location.

    Yes - it is! Scilife is cloud-hosted by Amazon Web Services (AWS), unsurpassed on the market for compliance and security. AWS is the best on the market, as per Gartner, holding this prized top spot for over a decade. Since we operate in a tightly regulated space, compliance is of prime importance. AWS meets all the essential compliance standards required in the Life Sciences industry.

    For more information see here.

    Scilife carries out annually it’s own Supplier Qualification Procedure on all of our suppliers, including AWS on an annual basis.

    Your data is fully encrypted, private and backed up. We use the Amazon S3 service for storing documents. This service replicates a file in three separate global locations as soon as it is uploaded, ensuring a robust data backup strategy. 

    Scilife is run on virtual application servers in the cloud, allowing it to scale out and scale down automatically depending on the usage demand at any particular moment. This saves costs on infrastructure, which translates into a highly cost-effective solution for you. It also protects against server failure, as new servers are activated automatically in minutes if hardware failures are detected. To safeguard database data, a snapshot is taken every 5 minutes as a data backup policy, and the backup is kept for 30 days. 

    We've got you covered! We understand that importing large amounts of documentation or records can be a daunting task. That's why we'll help you create a seamless transition plan for your documentation.

    Our team will guide you in analyzing your quality system and making the right choices. Once everything is clear, you can provide us with the data, and rest assured that no matter the volume of information, we will take care of the importing process for you in no time! After the data import has finished, we will ask you to verify and confirm that the data has been imported correctly. 

    Curious about Scilife's software licensing and installation? Like many SaaS platforms, Scilife is a cloud-based software with an annual subscription. Access is easy—just use your favorite web browser!

    Onboarding in a flash! We have a very systematic approach to onboarding new clients. Every customer is teamed up with a dedicated industry expert for a smooth onboarding experience. We hold weekly meetings on the progress of the project to completion. The goal is to get you trained, validated, and to go live with your data in production in the least amount of time. 

    Your onboarding timeline depends on your initial focus area, but you'll start seeing value within four to eight weeks. 

    We'll by your side every step of the way to help you:

    • Painlessly transition from your previous system
    • Migrate and import existing data
    • Set up integrations with your favorite tools
    • Settle in and train your team
    • Optimize the platform to fit your needs
    • Resolve any issues and remove roadblocks
    • Sort out validation if needed

    Yes, we offer additional onboarding services. If you need extra assistance or training beyond our standard offering, we'll tailor an onboarding plan to reach specific milestones in your quality transformation journey.

    With Scilife's cloud-based, modern technology stack, you'll enjoy regular enhancements and features tailored for your company - without the extra cost! 

    With each upgrade, we provide an updated validation package, which includes a change list containing information on the improvements that have been made. The updated validation documentation package is provided 60 days before each new version release. 

    During this time, you’ll already haveaccess to the new version in your Validation environment. All our customers have a 60-day time window to review, perform selected tests, and sign off on validation documentation on their end. Depending on the nature of the change, a medium or major version increase is assigned to the upgraded feature.

    Thinking globally? Scilife Platform works wonders for international organizations. We proudly serve companies in over x countries across 5 continents. No matter where you're located or which markets you're targeting, Scilife streamlines quality management for your team. Our software navigates international regulatory pathways and quality system requirements, so you can scale without breaking a sweat.




    Yes! In line with our continuous expansion efforts, Scilife has established a new subsidiary in the United States. This development allows us to better serve our US-based clients and strengthen our presence in the dynamic and innovative life sciences market. By having a local presence, we can provide more effective support and foster closer relationships with our customers, ensuring their success with our platform and services.