Who We Are

Globiox is a different kind of life sciences consulting firm, focused on providing you innovation, efficiency and results. We do more than simply augment staff. We work with you to understand your system needs and business objectives, both now and for the future. The result is a solution designed for your business and services customized to meet your goals.

From the Blog

June 11, 2014

Frequently we get calls from medical device companies telling us that they need to validate their processes, either because a...

	GxP IT Quality</p>

GxP IT Quality

IT departments in FDA regulated companies have a special challenge when it comes to IT GxP. IT is a technical expert but they also need GxP experts on their team to lead the way through challenges like...



Quality Management Systems are required for all FDA regulated entities, whether GMP, GLP or GCP. Some parts of the QMS are fairly straightforward, easy to develop and implement, whilst some require deep expertise...

	Vendor/Supplier Management</p>

Vendor/Supplier Management

Since outsourcing is so popular, vendor and supplier management has become more resource intensive. To combat this, many companies now outsource vendor and supplier qualification and management...

	Risk Assessment and Management</p>

Risk Assessment and Management

Risk assessment and management requires special expertise and they are critical foundations to almost everything else that is done in a company. If a company assesses risk thoroughly and manages it continually there is a much higher probability of success...



Validation is critical to ensure data and process integrity. Validation should not be a paperwork exercise but should be carefully planned based on risk and statistically sound sampling plans...

	21 CFR Part 11</p>

21 CFR Part 11

Compliance with 21 CFR Part 11 is an important aspect of ensuring electronic data integrity. Starting with an audit or gap analysis, Globiox can develop strategies for compliance for electronic and hybrid systems...

	Deviations and CAPA</p>

Deviations and CAPA

With lean workforces, FDA-regulated companies may find themselves with a backlog of deviations to be investigated and CAPAs to be resolved. Faster resolution using outsourcing results in less business, technical, patient, and regulatory risk...



Electronic Quality Management Systems should be configured to fit a company’s needs and workflows, and validated to ensure the configuration meets the requirements. If a company is not satisfied with their eQMS, it is often due to poor configuration...