Successful IT carve-out of CordenPharma using Rescop RC-SLM Software for ensure the GxP compliancy and paperless validation/qualification

Successful IT carve-out of CordenPharma using Rescop RC-SLM Software for ensure the GxP compliancy and paperless validation/qualification

 

In the ever-changing world of pharmaceutical development and manufacturing, achieving GxP compliance (Good Practice) is crucial. For Contract Development and Manufacturing Organizations (CDMOs) like CordenPharma, maintaining compliance while undergoing a complex carve-out process presents a unique challenge. This article explores how CordenPharma achieved a successful IT carve-out from its previous owner, ensuring seamless operations and paperless validation through a strategic partnership with Rescop and its innovative regulatory compliance software.

 

Company Profile: CordenPharma

CordenPharma has established itself as a leading force in the pharmaceutical industry, boasting a network of 12 sites across Europe and the USA. With a workforce exceeding 3,000 and generating revenues of 870 million Euros in 2022, the company stands as a titan in contract development and manufacturing. The acquisition of CordenPharma by Astorg in August 2022 marked a new chapter, paving the way for its transformation into an independent entity. This ambitious goal necessitated meticulous planning and innovative technology to ensure a smooth transition within the agreed-upon time limit.

 

The GxP Compliance Challenge

Among the hurdles faced during the carve-out, ensuring compliance with GxP regulations and implementing paperless validation/qualification processes were paramount. GxP compliance is an essential requirement for CDMOs like CordenPharma, as it guarantees the safety, quality, and efficacy of biopharmaceutical products. Maintaining compliance during a carve-out can be particularly complex, requiring meticulous attention to detail.

 

Rescop's RC-SLM: The future of compliance and validation technology

CordenPharma partnered with Rescop, a company specializing in regulatory compliance solutions for the pharmaceutical and biotechnology industries. Rescop's RC-SLM (Regulatory Compliance Software Lifecycle Management) software emerged as the linchpin in CordenPharma's strategy for achieving GxP compliance and paperless validation/qualification. This software is specifically designed to address the intricate needs of the industry, streamlining the entire lifecycle of regulatory compliance activities. RC-SLM facilitates efficient and fully compliant paperless validation and qualification processes.

 

Successful Implementation and Benefits

By implementing Rescop's RC-SLM software, CordenPharma successfully navigated the complexities of ensuring GxP compliance across all its sites for its infrastructure and global ERP and non-ERP applications. The software also empowered the company to transition towards a more sustainable, paperless operation. This shift played a vital role in the successful IT carve-out of CordenPharma, enabling it to become a standalone entity ahead of schedule and achieve significant cost savings.

 

Collaboration and Innovation

The success story of CordenPharma's carve-out is a testament to the power of collaboration. By leveraging Rescop's expertise in regulatory compliance and IT solutions, CordenPharma achieved a smoother transition and established a new standard for operational excellence. Rescop RC-SLM software not only aided the carve-out process but also set a benchmark for efficient and compliant operations within CordenPharma.

 

A Model for the Future

CordenPharma's journey exemplifies the future direction of the pharmaceutical industry, where technology and strategic partnerships revolutionize compliance and operational processes. The integration of RC-SLM software into CordenPharma's operations marks a significant milestone, underscoring the company's commitment to innovation, efficiency, and, most importantly, the development and manufacturing of safe and effective pharmaceutical products.

 

In conclusion, the successful IT carve-out of CordenPharma, powered by Rescop's RC-SLM software, is a clear indicator of the pharmaceutical industry's future direction. It serves as a shining example of how technology and strategic partnerships can revolutionize compliance and operational processes, setting a new benchmark for the industry at large.

 

For more details about how our software can transform your compliance and validation processes, or to contact us directly for a free demo, please visit our website: rescop.com.

Discover the power of Rescop's RC-SLM Software and take the first step towards enhancing your operational efficiency and compliance today.

 

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