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 overarching 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

Biotec webinar - Are you ready for the Annex VI EU No 536/2014 labeling changes? Are you ready for the Annex VI EU No 536/2014 labeling changes? Posted in: Business Analysis, Clinical Trials, Increasing The Operational Efficiency, Information Technology, Operations & Labeling, Overcoming The Technical Challenges, Project Managers, Supply Chain, Webinar -

Are your current packaging and labeling processes preventing you from creating a faster, more flexible supply chain?

Are you struggling to implement an on-demand packaging model...

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EU MDR Infographic 10 Sticking points Infographic - Medical Device Label Before and After EU MDR – 10 Sticking Points Medical Device Label Before and After EU MDR – 10 Sticking Points Posted in: Achieving Regulatory Compliance, Business Analysis, Infographic Archives, Medical Device, Operations & Labeling, Project Managers, Regulatory & Compliance -

EU MDR introduces additional information that needs to be included on labels, forcing organizations to design new label templates that make room for data not previously part of the labeling system.

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