Assisting with Consolidation

ASSISTING WITH CONSOLIDATION

With mergers and acquisitions prevalent in the life sciences industry, many organizations seek to consolidate vendors, systems and processes to reduce risk and improve quality.

Multiple software systems and vendors can lead to confusion with change control, training and maintenance costs, a lack of consistency and interoperability between systems, as well as constraints on IT flexibility.

More significantly, these inconsistent systems and processes will invariably delay time-to-market for medical device or pharmaceutical products.

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How we helped one of our clients with this challenge:

  • Massachusetts, USA headquartered global organization
  • Operational challenges from legacy systems located across 24 sites. Huge cost and long delays bringing on new users, sites and third parties into the solution
  • Integrated five separate databases into a single, enterprise-wide labeling system for a single source of the truth
  • Consolidated into one centralized solution which assisted in change control and bringing in new/third party users
  • Estimated $10M per annum saved through prevention of recalls and able to go live globally within 6 months across all sites and users after OQ (Operational Qualifications).

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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ASSISTING WITH CONSOLIDATION LABELING RESOURCES

Aligning For Growth whitepaper 2 - Aligning For Growth: The Evolution Of Medical Device Labeling Aligning For Growth: The Evolution Of Medical Device Labeling Posted in: Assisting With The Consolidation, Business Analysis, Enabling the Expansion, Medical Device, Operations & Labeling, Supply Chain, Whitepaper -

The introduction of Unique Device Identification (UDI)regulations signals a seismic shift in the labeling of medical devices. Over the past twenty years, the development of labeling solutions for the highly regulated devices sector...

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