TwitterLinkedin

Contact Us

  • Biopharma Excellence
  • News & Events
    • Industry News Articles
    • Press Releases
    • Webinars
    • Events
    • Blog
    • Podcasts
  • Resource Library
    • Thought Leadership
    • Fact Flyers
    • Case Studies
    • White Papers
    • Webinars
    • Infographics
    • Video & Animation
  • Careers
    • Life at PharmaLex
    • Current Opportunities
  • Training
Top Bar
Search
PharmaLex Logo
MENUMENU
  • PharmaLex Logo
  • PharmaLex Logo
  • About UsAbout Us
    • About Us
    • Management Team
    • Corporate Social Responsibility
    • What Our Clients Say About Us
  • Our Services
    • Discovery / Non-clinical
          • Go to Discovery / Non-clinical section >>

          • Strategy and Consulting

            • Integrated Product Development
            • Market Access
            • Scientific Advice
            • Statistics and Data Sciences
            • Toxicology Services
    • Clinical Development
          • Go to Clinical Development section >>

          • Strategy and Consulting

            • Clinical Program Development
            • Scientific Advice
            • Statistics and Data Sciences
          • Regulatory Affairs

            • Clinical Trial Applications
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Regulatory Operations
          • Pharmacovigilance

            • Clinical Trial Safety Support
            • Pharmacovigilance Consulting
          • Quality

            • GxP Services
            • Interim / Contract QA
            • Quality Management Systems
            • Tech Transfer / Scale-up
    • Authorization / Approval
          • Go to Authorization / Approval section >>

          • Strategy and Consulting

            • Market Access
          • Regulatory Affairs

            • CMC Services
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Marketing and Labeling Activities
            • Regulatory Operations
            • Scientific, Regulatory and Technical Writing
            • Statistics and Data Sciences
          • Pharmacovigilance

            • EU QPPV / National QPPV
            • Pharmacovigilance Consulting
          • Quality

            • Commercialization Readiness
            • Commissioning, Qualification, and Validation (CQV)
            • GxP Services
            • Interim / Contract QA
            • PAI Readiness
    • Post-approval / Maintenance
          • Go to Post-approval / Maintenance section >>

          • Strategy and Consulting

            • Market Access
          • Regulatory Affairs

            • CMC Services
            • Global End-to-End Outsourcing
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Marketing and Labeling Activities
            • Mergers and Acquisitions (M&A) Transfers
            • Regulatory Operations
            • Toxicology Services
          • Pharmacovigilance

            • EU QPPV / National QPPV
            • ICSR (Individual Safety Case Report) Management
            • Literature Monitoring & Screening
            • Pharmacovigilance Quality & Compliance
            • Signal Management
          • Quality

            • Commissioning, Qualification, and Validation (CQV)
            • GxP Services
            • Interim / Contract QA
            • Quality Management Systems
          • Medical Affairs

            • Healthcare Compliance and Medical Approval
    • Program Management
          • Go to Program Management section >>

          • Program Management

            • Global End-to-End Outsourcing
            • Global Procedure Management
            • Integrated Product Development
            • Mergers and Acquisitions (M&A) Transfers
    • Featured Expertise
          • Industry Expertise

            • Biopharmaceuticals
            • MedTech Services
          • Service Expertise

            • ATMP / Cell and Gene Therapy
            • COVID-19 Support
            • GxP Services
            • Market Access
            • Pharmacovigilance Consulting
            • Post-Brexit Regulatory Support
            • Statistics and Data Sciences
            • SMARTPHLEX - technology-enabled services
  • Global ReachGlobal Reach
  • Contact usContact us
  • News & Events
    • Industry News Articles
    • Press Releases
    • Webinars
    • Events
    • Blog
    • Podcasts
  • Resource Library
    • Thought Leadership
    • Fact Flyers
    • Case Studies
    • White Papers
    • Webinars
    • Infographics
    • Video & Animation
  • Careers
    • Life at PharmaLex
    • Career Opportunities
  • Training
Home > SMARTPHLEX > SMARTRISK

SMARTRISK

Helping you reduce risk whilst maintaining compliance

SMARTRISK is a next generation risk assessment tool developed to assist companies with the correct implementation of the EU Guidelines of 19 March 2015 on the formalized risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use.

The intent of the tool is to assist MA Holders with the correct implementation and execution of a Formal Risk Assessment that is in compliance with the intent and purpose outlined in the EU guidance document.

This is the first Risk Assessment Tool (or module) that has been developed as part of SMARTRISK. Further tools have been developed and will be added as future available modules on the SMARTRISK platform.

To find out more or request a demonstration

CONTACT US

Features

  • Compliance: Ensures compliance awareness with the EU Guidance through incorporation of the guidelines into the structure of the Risk Assessment tool
  • Guidance: Ensures that the MAH performing the Excipient Risk Assessment assesses the GMP controls that they need for the excipient and then performs a gap analysis against their current or proposed suppliers
  • Security: Provides data security for the Excipient Risk Assessment through audit trail, controlled access and revision control
  • Risk Mitigation: Identifies level of risk  which enables the MAH to take action to control the level of risk where required to ensure mitigation of the risk and GMP compliance of their excipients
  • Objective Assessment: Standardizes the scoring applied to each parameter using clear and concise definitions to minimize subjective scoring, reducing bias and encouraging an objective assessment of risk
  • Reporting: Provides reporting by excipient or a summary of all excipients in the risk assessment

Benefits

  • User Friendly:  Interfaces with the company’s ERP system to upload existing excipients and formulations. It is user-friendly and requires no additional knowledge about IT systems
  • Stability:  Built on Microsoft’s Azure cloud platform, there is no dependency on third-party software thus reducing the risk of error with Microsoft’s high service level agreements (99.9% uptime guarantee)
  • Availability – Securely accessible from any internet enabled location / device without the need for any specific software
  • Usability – Redeveloped interface focused on performance and optimized user journeys, reducing effort required to enter, maintain and assess data, with all information about excipients and formulations captured in one database
  • Control – improved audit trail functionality and visibility

PharmaLex expert Kate Coleman explains what SMARTRISK actually is

Kate is a Quality professional with 18 years experience in the Pharmaceutical Industry across several platforms including Biologics, Sterile Fill Finish, High Potency oncology and Solid Oral Dose products. Kate is an SME in Quality Risk Management and works with her clients to deliver and remediate QRM programs providing efficiency and clarity across the product lifecycle.
In the video, Kate explains the most important information about SMARTRISK and gives  an impressive overview of the next generation risk assessment tool.

Related News

Gestion de l’information et mise en conformité règlementaire
Gestion de l’information et mise en conformité règlementaire
2nd August 2021
GET SMART: reliable analytical results & continuous regulatory compliance!
GET SMART: reliable analytical results & continuous regulatory compliance!
30th March 2021
SMARTRISK - risk assessment excipient tool
SMARTRISK - risk assessment excipient tool
12th January 2021

Related Resources

Thought Leadership

  • Together Beyond COVID-19 - A Look to the Future

Fact Flyers

  • SMARTVIGILIT - Flyer
  • SMARTVIGICONTRACT - Flyer
  • SMARTRISK - Flyer
  • SMARTVIGISCREEN - Flyer

Webinars

  • Excipient Risk Assessment as per the EU Guidance and SMARTRISK as a solution
  • Eudravigilance: overcoming challenges and gaining efficiencies with SMARTVIGISCREEN
  • Software Suite for the Life Cycle of Analytical Methods & Bioassays: Gain Trust in your Results

Video & Animation

  • SMARTRISK - Walkthrough the application
  • Using Technology-enabled Smart Services - what are the benefits?
  • SMARTPHLEX - Technology-enabled Smart Solutions
  • SMARTRISK - What is SMARTRISK

Related Services

  • Digital Health Teaser Tool
  • SMART MDR Teaser Tool
  • SMARTAUTOMATE
  • SMARTCHECK MDR
  • SMARTCHECK-MDR
  • SMARTDECISIONS
  • SMARTPHLEX
  • SMARTTRACE
  • SMARTVIGICONTRACT
  • SMARTVIGILIT
  • SMARTVIGISCREEN
Biopharma Excellence Website Image

PharmaLex Brings You Biopharma Excellence

Biopharma Excellence is a fusion of three scientific powerhouses, PharmaLex, ERA Consulting and Biopharma Excellence – all under the PharmaLex brand. This global team of scientific, regulatory and commercial professionals provide strategic product development and proactive regulatory services to developers of biopharmaceuticals, cell and gene therapies, monoclonal antibodies (MABs), vaccines and biosimilars.

Visit Website
USEFUL LINKS
  • Home
  • Contact us
  • Imprint
  • Data Protection
  • Terms and Conditions
RECENT TWEETS
PharmaLexGLOBALPharmaLex@PharmaLexGLOBAL·
24 Jun

Milena Shuytsova-Mircheva and Lisa Pascoe latest blog here https://www.pharmalex.com/sponsors-gear-up-for-a-smoother-process-with-ctis-but-must-first-overcome-key-hurdles/ discusses the benefit of the Clinical Trial Information System (CTIS).

💡 Interested in CTIS? Take the Phlexglobal survey to evaluate your preparation https://www.phlexglobal.com/ctis-survey

COVID-19 NEWSLETTER SIGN UP

SIGN UP NOW

WHAT OUR CLIENTS SAY
  • Our project team were very impressed with the quality of the research and the reports that you sent through. We didn’t need any convincing that your recommendations should be followed. It showed PharmaLex in a very positive light, and the Project Team are keen to work with you again.

    Leading European Specialist Pharma Company
    Head of Medical Writing and Publications
PharmaLex
©2022 PharmaLex GmbH. All rights reserved.

ISO9001:2015 LogoEnergie Audit LogoSGS Logo

Suspicious Emails

We are aware of a number of suspicious emails about recruitment in circulation purporting to be from PharmaLex. Emails sent by PharmaLex will originate from @pharmalex.com. Should you receive an email and are unsure as to its validity, please report it to contact@pharmalex.com.

Many thanks for your understanding.

The PharmaLex Team

    Please DO NOT send us event/conference information.
    We will not respond and these will be deleted immediately.






    Select your state:

    .
    If you do not wish to receive any communication from us, you may unsubscribe at any time.

    #AskTheExpert #TogetherBEYONDCOVID19





      Select your state:

      .
      You can unsubscribe at any time at data.protection@pharmalex.com

      If you do not wish to receive any communication from us, you can unsubscribe at any time at. Click here to view our Privacy Policy.

      #TogetherBEYONDCOVID19

      We closely monitor developments and updates surrounding the current outbreak of Coronavirus Disease 2019 (COVID-19) from official sources including the World Health Organisation and are following the guidance and direction of the governments and the local authorities. We are taking this situation very seriously and our number one priority is the safety and business continuity for our customers and colleagues. As ever, we will do everything we can to ensure that services are delivered within the required time and the trusted quality PharmaLex is known for