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What is SENDIG v3.1.1 from CDISC?

All pharmaceutical companies, biotechs and contract research organizations (CROs) are required to prepare data according to the CDISC formats. Sponsors will be required to use these formats by the FDA, and consequently, CROs are increasingly expected to provide study results in these formats. Working with commercial software vendors can help ease the burden of complying with evolving format standards, while also helping you leverage best practices in a GLP regulated environment. 
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The image shows a laboratory setting with various pieces of scientific glassware filled with a blue liquid on a metal countertop. In the background, three scientists are engaged in their work, with one peering through a microscope.

6 Considerations for Workforce Safety in Regulated Laboratories

Laboratories are full of hazardous materials such as precursors, lead, benzene, and other chemicals, indicating regulatory compliance is a must for all laboratories. Not only does compliance help to mitigate unnecessary risks of working in such an environment, but any violation can attract a fine of more than $30,000 per day per violation, along with criminal penalties.
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Maintaining Record Integrity Through ECM Migration

In today’s business environment, electronic records are produced every second. Understanding this basic fact has profound implications on your technology infrastructure, business processes, information security, and record retention policies. It is understood that electronic records produced during the normal course of business explicitly represent “corporate memory” for the organization.
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Proactive Audit Management – What You Should Know

Effectively managing audits is essential to any quality management program. Good audit management helps to proactively ensure quality by measuring and improving processes, procedures, and marketed services and products. In addition, supplied products and services can be audited to ensure quality adherence throughout the entire value chain.
Read More

Effective Process Change Control

The old adage that — the only thing constant is change — is true. Within organizations, changes are always occurring due to market drivers, staff changes, new regulations, resource availability, and technological changes. These changes can include changes in policies and procedures, processes, systems, staff, products, services, equipment, materials, emissions, etc.
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Corrective & Preventive Actions – Closing the Loop

Implementing effective and comprehensive CAPA in a timely manner continues to be a major problem among medical device, pharmaceutical, and biological companies. The lack of follow-up and close-out are frequently mentioned.
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What is SENDIG v3.1.1 from CDISC?

August 29, 2021

All pharmaceutical companies, biotechs and contract research organizations (CROs) are required to prepare data according to the CDISC formats. Sponsors will be required to use these formats by the FDA, and consequently, CROs are increasingly expected to provide study results in these formats. Working with commercial software vendors can help ease the burden of complying with evolving format standards, while also helping you leverage best practices in a GLP regulated environment. 

Read More »
The image shows a laboratory setting with various pieces of scientific glassware filled with a blue liquid on a metal countertop. In the background, three scientists are engaged in their work, with one peering through a microscope.

6 Considerations for Workforce Safety in Regulated Laboratories

July 20, 2021

Laboratories are full of hazardous materials such as precursors, lead, benzene, and other chemicals, indicating regulatory compliance is a must for all laboratories. Not only does compliance help to mitigate unnecessary risks of working in such an environment, but any violation can attract a fine of more than $30,000 per day per violation, along with criminal penalties.

Read More »

Maintaining Record Integrity Through ECM Migration

May 16, 2021

In today’s business environment, electronic records are produced every second. Understanding this basic fact has profound implications on your technology infrastructure, business processes, information security, and record retention policies. It is understood that electronic records produced during the normal course of business explicitly represent “corporate memory” for the organization.

Read More »

Proactive Audit Management – What You Should Know

May 16, 2021

Effectively managing audits is essential to any quality management program. Good audit management helps to proactively ensure quality by measuring and improving processes, procedures, and marketed services and products. In addition, supplied products and services can be audited to ensure quality adherence throughout the entire value chain.

Read More »

Effective Process Change Control

May 16, 2021

The old adage that — the only thing constant is change — is true. Within organizations, changes are always occurring due to market drivers, staff changes, new regulations, resource availability, and technological changes. These changes can include changes in policies and procedures, processes, systems, staff, products, services, equipment, materials, emissions, etc.

Read More »