Business Analysis

IS YOUR ROLE BUSINESS ANALYSIS?

As a Business Analyst, you are critical in choosing the right labeling solution. You are in a unique position of researching, understanding and recommending the overarch infrastructure of the required solution, along with its challenges and opportunities.

It is your responsibility to convey these findings to key stakeholders.

We provide not only a configurable labeling solution that enables you to meet all the requirements of the project, but we also have our internal experts ready to discuss any specific needs. Our in-house teams can support you with validation and compliance through project planning, risk assessment, testing implementations and supply full documentation.

“We knew what level of quality we required and the PRISYM system not only delivered, but exceeded our expectations. Unlike PRISYM, many of the other systems we considered did not provide the correct level of service and security, which is an especially important factor in our industry. Plus, the PRISYM ID’s labeling software is user-friendly and has a very useful reminder mechanism.”

CHOSEN BY THESE CUSTOMERS...

OFFERING THESE PRODUCTS AND SERVICES...

PRISYM 360

This solution provides organizations with complete label integrity to meet the strictest compliance requirements for FDA & EU regulations, specifically FDA 21 CFR Parts 11, 810, and 820.

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PRISYM SaaS

This solution enables organizations to address the challenges of complying with FDA and other regulations by delivering access to a compliance ready platform in the Cloud.

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SERVICES

Our team of in-house compliance and validation subject matter experts and professional services and support teams can support you from implementation through beyond delivery.

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BUSINESS ANALYSIS LABELING RESOURCES

EU MDR Labeling – ‘Touch Your Label Once’ Strategy EU MDR Labeling – ‘Touch Your Label Once’ Strategy Posted in: Achieving Regulatory Compliance, Assisting with Consolidation, Business Analysis, Increasing Operational Efficiency, Information Technology, Medical Device, Operations & Labeling, Overcoming Technical Challenges, Project Managers, Reducing Risks, Regulatory & Compliance, Supply Chain, Webinar -

Join PRISYM ID for this free webinar to learn how an effective “touch your label once” strategy for EU MDR labeling can streamline processes and reduce the cost of a global label change.

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PRISYM ID 10 Steps to EU MDR Labeling Implementation Guide 10 Steps to EU MDR Labeling Implementation Posted in: Achieving Regulatory Compliance, Business Analysis, Increasing Operational Efficiency, Medical Device, Operations & Labeling, Project Managers, Regulatory & Compliance, Whitepaper -

Whether you’re producing medical devices within Europe or supplying to Europe, as a manufacturer or supplier, you will need to adhere to the new EU MDR.

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