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Posted on: March 26-2018 | By : Sourav Gupta | In: Industries,Life Sciences | No Comments

Recent posts

    The journey so far


    Year 2017 was a learning phase for the Medical Device industry. With the official launch of the European Medical Device Regulations (EU MDR 2017/745) and European In-Vitro Diagnostic Regulations (EU IVDR 2017/746), many medical device and in-vitro diagnostic companies faced uncertainty and confusion over the new requirements, as well as risks and challenges to their business.


    With few exceptions, I have seen most large manufacturers establish a program management (PMO) team and roping in top management consulting companies to help determine the impact on their business and revenues. Small and mid-size companies are working with regulatory consultants to understand the new requirements.


    The second half of the last year was mostly spent on awareness sessions, workshops, gap assessment pilots and budget planning. I have spoken to many program directors to understand their strategy, budget and plan for the next two to three years, and led or participated in many knowledge sessions and workgroups. I have learned a great deal so far, and hope to share some of that with you today.


    Key Lessons


    1. Simplify program management by creating a 360° view dashboard for each product family. This dashboard should include parameters like revenue, markets, risks, technical files, labels/IFUs, authorized representative, notified body, manufacturing sites, economic operators, QMS, etc., along with your key stakeholders from various functions.

    2. Remove redundancy and organize technical files and design dossiers for each product family in a centralized repository.

    3. Digitize high-value legacy records and technical documents for gap assessment, inspection readiness and easy availability.

    4. Plan ahead for your organization-wide implementation or upgrade to QMS ISO EN 13485:2016, MEDDEV 2.7.1 rev.4, UDI, eIFU Website (Content Management Framework).

    5. Prioritize the remediation of technical files for products with high business impact and complexity.

    6. Evaluate and onboard service providers early in the program to improve the success rate and on-time completion.

    7. Build an agile platform that enables internal and external stakeholders to engage and collaborate on a day-to-day basis.

    8. Implement tools and accelerators to improve visibility, tracking, quality and productivity across workstream projects and your overall program.


    Key Lessons


    While the industry is waiting for the re-designation of the Notified Bodies, most manufacturers have completed the impact and gap assessment of key technical files and are currently planning for technical file remediation. Keep in mind that if you have a high volume of technical documents, or they are complex, in legacy formats, or not well-controlled or documented under the same product family, remediation will require much more advance planning.


    Key considerations for technical file remediation


    Planning
    • Create/ update SOPs

    • Prepare quality plans for technical files and design history files (DHF)

    • Plan cross-functional work streams for document remediation

    • Identify critical success factors, risks and challenges

    • Develop a detailed checklist to review technical files

    Reformatting GHTF
    Summary Technical
    Documentation (STED)
    • Update formats (GHTF/SG1/N011:2008 for medical devices; GHTF/SG1/N063:2011 for in-vitro diagnostic devices) to align with the new requirements

    • Format documents into paginated and fully searchable PDF files

    • Devise a logical numbering for files (e.g. Part 1 of x, Part 2 of x… Part x of x)

    • Bookmark GHTF STED sections with clear document references

    • Write technical files in an official language of the member state where procedures are carried out, or the language accepted by the Notified Body. English is recommended for all audit-related documents.

    • Use digital signatures or scanned signature pages where signatures are required

    • Make the technical documentation a pointer document

    General Safety
    and Performance Requirements
    Checklist
    • Update the Essential Requirement Checklist (ERC) and map to the new requirements

    • Mention relevant standards “State of the Art” assessments (fully or partially applied)

    • Provide reference to harmonized standards and justification if not applicable

    • Look for objective evidence to support conformity, linking and bookmarks to relevant documents

    Declaration of Conformity
    • Ensure the product list in the technical documentation matches the DOC

    • Sign a new Declaration of Conformity


    Conclusion


    It requires extremely careful planning and monitoring of different workstreams to successfully remediate technical files. By identifying critical success factors, risks and challenges early on, your planning will be easier and the chances of a “first-time-right” remediation program improve dramatically. By setting-up a digital PMO dashboard, QC checklists, tools and accelerators, you can help ensure a much smoother transition to EU MDR/ IVDR compliance.


    Author
    Sourav Gupta

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    Sourav Gupta
    Sourav Gupta has 14+ years of experience supporting the Life Sciences industry in the clinical,...

     
    Posted on: March 12-2018 | By : Imran Sheikh | In: Life Sciences | 1 Comment

    Recent posts

      Although high-profile data breaches grab the headlines, behind the scenes, life sciences is just as information sensitive as any industry. Any pharma company faces a major challenge when it comes to complying with the myriad regulatory requirements about how they create, handle and submit documentation about the products they manufacture.


      Even a minor slip up can have a serious financial impact in the form of fines, penalties, or delayed product launches. With so much at stake, document management is a critical process for any pharma companies.


      There are a number of widely-accepted best practices to ensure compliance with regulations, but many of these are extremely complex to implement, meaning that the industry has struggled for years to put them in place. These include:


      • Harmonizing and standardizing all global regulatory submission templates
      • Keeping on top of changing and emerging requirements and timelines
      • Implementing strong versioning and change management practices
      • Maintaining strong governance and process management controls
      • Capturing key performance metrics and feedback from regulatory authorities


      At Syntel, our prescription to these challenges is a suite of end-to-end regulatory services, driven by an intelligent regulatory services platform. We combine the power of automation and decades of business process expertise to implement standardized, trusted processes for regulatory operations and submissions to health authorities. We can deliver business outcomes such as:


      • 20% reduction in regulatory writing and submission publishing time
      • Dramatic improvements in submission quality
      • Consistent templates for all clinical documents
      • Easier document lifecycle management


      A huge added benefit to more structured and consistent document management is the ability to capture rich metrics at every step in the process. By making the document initiation, preparation and publication process more transparent, we can deliver deep insights into your operations and make continuous process improvement a reality.


      If you are ready to take the next step in your document management operations, visit us online at https://www.syntelinc.com/industries/life-sciences.


      Author
      Imran Sheikh

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      Imran Sheikh
      Imran Sheikh is Sr. Consultant, Regulatory Affairs at Syntel. He has over 10 years of rich...

       
      Posted on: January 03-2018 | By : Rahul Ganar | In: Industries,Life Sciences,Pharmaceuticals and Biotech,TMF Management | No Comments

      TMF practices have matured considerably, and are now recognized as a critical step in the drug development cycle. However, a number of challenges persist. One key issue facing the entire life sciences industry is the fact that sponsors, CROs and affiliates often maintain multiple TMF instances — which increases the manual work required and creates redundant practices and processes that increase the complexity of TMF management.


      Other challenges that the Life Sciences industry faces today include:


      • CRO coordination, to ensure the right documents are available during audits and inspections.In many cases, CROs manage their TMF system and sponsors manage their own. This makes it difficult to ensure the accuracy, completeness and timeliness of documents, as there is no clear ownership or accountability of TMF documents.
      • Governance, for better sponsor oversight and governance of CROs, affiliates and other functional service providers for TMF management. Document submission timeline is also an issue, as documents are often pushed on to the TMF system at the time of inspection, and not on a regular basis
      • Quality by Design, TMF operations for many life sciences organizations are combined with clinical trials and regulatory document management functions. This leads to quality issues, because there is not an exclusive focus on TMF documentation, which needs a more thorough and focused approach.


      Is your organization facing any of these challenges? Do you need help providing answers in advance of an audit or inspection? If so, we want to hear from you, learn about your challenges, and explore how we can work together to ensure that your organization is always audit and inspection ready.


      To start the conversation, reply or comment below, or reach out to us at LifeSciences@syntelinc.com


      Author
      Rahul Ganar

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      Rahul Ganar
      Rahul Ganar, Senior Business Analyst, Life Sciences, Syntel has more than 10 years of domain and IT...

       
      Posted on: December 01-2017 | By : Subhajit_D | In: Artificial Intelligence,Industries,Project Management | 8 Comments

      The 2001 French romantic comedy Amelie told the story of a shy waitress who decides to change the lives of those around her for the better, while struggling with her own isolation.

      The painting below captures one of the 222 moods that the main character depicted in the movie. It was drawn by an aspiring artist that claims the goal of the project was, “To be taken seriously — one day — as a creative artist in my own right.”

      Before we continue, see if you can answer the following two questions:

      1. Who is the painter?

      2. Why are we talking about a movie and a painting when this article is supposed to be about merchandizing and AI?

      To answer the first question, the name of the painter is The Painting Fool, an AI enabled computer program that skillfully simulates the painting process. However, the answer to the second question is much more interesting.

      Merchandising and the role of merchandiser has always been about creating a relationship between a brand and a consumer, to the extent that it evokes a strong emotion and a behavior. Merchandisers are the fuel that drives a store’s vision for inventory, tells a compelling story that influences customer desires, helps them relate that feeling to a product line, and triggers the sale.


      While there are more or less “scientific” merchandising principles, formulas and theories, the knowledge, experience and intuition of the retailer brings something indispensable to the table – the “art” of merchandising. This brings us squarely back to the answer to question #2 above.

      At Syntel, we always keep an eye on the horizon, and have been steadily investing in developing an ecosystem where designers, merchandisers and buyers will leverage AI to predict what customers want before they even know themselves.

      We believe that the future of Merchandising will capitalize on the inherent creativity of the human mind, backed by AI-driven creative algorithms. Clearly, merchandising design and planning requires a lot of creativity and prediction to succeed, and AI and ML will help lead the path forward.

      As a trusted technology partner, Syntel can help our clients harness AI and ML to progress in their Merchandising journey by focusing on:

      • Customer Experience AI: Assemble and recombine a series of components and thousands of potential configurations to identify factors that drive maximum impact and saleshe painter?

      • Managing Variations through Automation: Define and manage automation algorithms and large data sets that use continual iterative A/B testing to pick “winners” for customer latent needs

      • Mental and Data Models to Recommendation Engines: Use a data-driven approach to build inputs that run the recommendation engines

      • Capturing Nuanced Customer Triggers and Signals: Capture and identify the customer responses of and discover insights that define discovery of next generation traits

      If the pundits are right and AI truly does take off as predicted, this technology will have a role to play in virtually every aspect of our lives. If the work of The Painting Fool is any indication, even creative fields like Merchandising may experience a “bot” explosion. To capitalize on this wave of innovation, you need a partner that is well-versed in the latest technology but has a deeply-rooted understanding of your business.

      To find out how Syntel can help, please reach out to your Syntel Client Partner or learn more about our AI and Machine Learning solutions online at www.syntelinc.com

      Author
      Subhajit_D

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      Subhajit_D
      A graduate from IIM Calcutta with 10 years’ experience in the industry, Subhajit Dutta is a...

       
      Posted on: October 06-2017 | By : Prasanna Sukuru | In: Agile,Project Management | 1 Comment

      Recent posts

        We are all aware that in Scrum teams, a great deal of importance is put on team collaboration, positive team dynamics, face-to-face communication, responsiveness to change, early feedback to customers and ROI – all in a fast paced setting.

         

        That puts a great deal pressure on the teams, so it helps have an additional edge apart from the high technical competencies required. So, what kind of edge?

         

        For starters, I believe one way to get that edge is to embrace mindfulness, a spiritual concept which is defined as paying attention in a particular way: on purpose, in the present moment, and non-judgmentally.

         

        There would seem to be no apparent connection between the two concepts, since Scrum is a hard-boiled project management methodology, while mindfulness may have stronger associations with a Yoga studio than a Scrum room.

         

        However, mindfulness helps promote openness, reflection, discovery, flexibility, adaptability, focused evaluation, and pragmatic decision making. These in turn are closely linked to benefits like increased creativity, innovation, emotional intelligence, empathic interpersonal relationships and the flexibility to accept change — all of which are critical to success in Agile teams.

         

        Below, I have illustrated the close connection between Agile philosophy and the principles of mindfulness.

         

        Agile Philosophy Mindfulness Principles
        Individuals and interactions over processes and tools Empathy Awareness
        Working software over comprehensive documentation Focus Motivation
        Customer collaboration over contract negotiation Non-Judgement Empathy
        Responding to change over following a plan Awareness Empathy

        It would appear that there is some overlap between mindfulness and Agile, so let’s look at two such core principles that can contribute to higher productivity and greater success.

         

        People:

         

        Both Agile and mindfulness focus on the ability to listen, understand, and use skill to respond to the needs of others.

         

        By strengthening and leveraging emotional intelligence through mindfulness techniques, Agile teams can learn to listen better and establish better connections with both the customer and within the team itself, which in turn boosts quality and productivity.

         

        Simplicity:

         

        One of the twelve principles outlined in the Agile manifesto is simplicity. The focus is on high value yet simple processes and solutions that reduce waste and increase quality.

         

        Mindfulness helps people become aware of unnecessary mental clutter, and enhances the skill of making simple choices. Someone practising mindfulness can identify and let go of energy-draining thoughts like negativity and uncertainty before they become problematic.

         

        Similarly, Agile focuses on simple designs, short meetings, and avoiding long discussions. Activities are organized based on priority and efficiency, which requires teams to be extremely focused and driven. Mindfulness techniques like emotional de-cluttering can help teams focus better.

         

        How to Apply Mindfulness Techniques

         

        There is more than one way to practice mindfulness, but the goal of any mindfulness technique is to achieve a state of alert, focused relaxation. This is achieved by deliberately paying attention to your thoughts and sensations without judgment, and steering the mind into the present moment.

         

        There are many techniques that take very little effort and can be done practically anywhere, anytime, such as Meditation, Mindful Immersion, Mindful Observation, Mindful Appreciation, Mindful Breathing and others. Below are some pointers on two important techniques.

         

        Meditation

         

        Broadly speaking, all mindfulness techniques are a form of meditation. Meditation is about remaining calm and effortless in an uncertain world. The Agile/Scrum world is set-up to respond to unpredictability, whether it’s changing user requirements, deliverables, deadlines, or unforeseen glitches.

         

        Meditation does the same. You go with the flow of your feelings, whether pleasant or unpleasant, and never push or force your mind or thoughts.

         

        The benefits or meditation are well-recognized and quantifiable. In fact, one insurance company reported a decrease in healthcare costs and an increase in productivity among employees trained in mindfulness/meditation. Many Olympic athletes attribute their success to meditation practices, and Google even has a formal employee meditation program, whose motto is, “Greater complexity outside requires greater clarity inside.”

        Mindful Breathing

         

        Another important aspect is focus on the breath, which is closely linked to our emotions and sense of well-being. Breathing techniques, when practiced regularly, foster more positive emotions and help steer an anxious, angry or regretful mind back to the present moment.

         

        In the Agile world, being in the present moment is essential, especially during a Sprint. It won’t help if the team is bogged down by thoughts of past Sprints or future Sprints. In the moment, the Sprint must become like your own breath, and one of the best ways the team can get back on track is to make the sprint commitment the clear focus of attention for everyone.

         

        Still skeptical? The only way to prove me wrong is to try promoting mindfulness on your own team.

        There’s literally nothing to lose, yet you stand to gain a more positive environment, happier Scrum teams, increased productivity, greater flexibility and adaptability, better focus, and clear-headed, pragmatic decision making.

         

        Try it out and let me know how it works on your team. Or, comment below and share your own experience with mindfulness.

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        Prasanna Sukuru is a Principal Consultant and leads Syntel’s Agile Center of Excellence. She has...

         
         

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