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Life Sciences

GxP Partners is a trusted technology partner within life sciences organizations, particularly in the quality assurance and manufacturing arenas. Many of our employees are pharmaceutical industry veterans with a thorough understanding of regulations and years of experience in computer software development, integration, validation, and training. Our experience in balancing stringent compliance requirements with the realities of doing business makes GxP Partners’ solutions ideal for both large- and mid-size companies.

We offer solutions for:

Pharmaceutical & Biotechnology Medical Device CROs / CMOs

Just a few examples of GxP Partners in action:

A global rollout of an innovative FDA-compliant quality management system, including all project management, implementation, validation, and training, within a leading medical device company. The system offers an integrated approach to managing all worldwide compliance and quality operations – from CAPA, complaints, audits, document control, and SOP enforcement through to employee certification and training and supplier quality management.

A batch release system, compliant with 21 CFR Part 11, for a leading global pharmaceutical company. The system gathers data from a front-end MRP system as manufacturing orders are created. A separate interface allows production managers to review and update jobs, with required electronic signatures. An automated polling interface monitors the printing job database and, if all audit checks pass, the system assembles the order package. The package – including all documents, forms, and product labels required to complete the order – is converted to a single PDF that’s automatically saved to the DM system and printed where needed.

A global rollout of an innovative FDA-compliant learning management system within a leading pharmaceutical company. The implementation includes all validation and training.

Assisted multiple clients in complying with 483 and consent decree requirements related to quality management, employee training, and system validation.

 

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