GxP Compliance Software

If you work in a regulated industry, odds are you’ve heard the term “GxP.” GxP refers to good practice regulations and standards. GxP software systems help companies comply with these requirements.

GxPs are “good [variable] practices” determined by regulations and standards in different industries. Examples include good manufacturing practices (GMP), good clinical practices (GCP), and good laboratory practices (GLP). If you see a “C” thrown in front of these, it simply means that you’re talking about “current” GxPs. GxP software solutions help companies comply with all of these. If more than one group of practices applies to your company, you need software to match. The MasterControl Product Lifecycle Excellence Platform has solutions for GxPs in any industry. 

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What Is GxP?

GxP generally refers to GMP, GLP and GCP regulations and guidelines established by the U.S. Food and Drug Administration (FDA). Other organizations, such as ISO and ICH, have similar requirements. Many regulated companies utilize a GxP system, which typically consists of various processes designed for the purposes of GxP compliance.

What Are the 5 P’s of GxP?

GxPs tend to be based on similar principles and requirements. There are similarities in the gxp meanings among the guidelines and regulations that can be summarized as 5 P’s.

  • People

    Employees have to know their jobs, be trained on them, and follow procedures.

  • Procedures

    Procedures must be documented, clear and followed. Any deviations must be documented and investigated.

  • Products

    Specifications have to be clearly documented and followed. Standard methods for testing, labeling and packaging must be used.

  • Premises

    Facilities and equipment have to meet regulatory standards. There must be controls for cleanliness and avoiding cross contamination.

  • Process

    Processes must be clearly defined and documented. Change control procedures need to be robust and documented.

GxP Regulations

01

Good Manufacturing Practices

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GMPs aren’t exactly the same across industries. However, they basically come down to ensuring quality and safety in production. A quality management system (QMS) is essential to maintaining GMPs in any industry. A QMS that can integrate with manufacturing software is even better.

02

Good Clinical Practices

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GCPs are all about protecting patients and ensuring data integrity during a clinical trial. Regulations and standards worldwide are generally based on these concerns.

03

Good Laboratory Practices

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GLPs apply to nonclinical laboratory studies. The FDA enforces GLPs for studies that support products that it regulates. A different set of regulations apply to clinical laboratory diagnostic testing for humans.

Aligning GxP Compliance

Regulated companies have a plethora of regulations to meet. The FDA has 21 CFR and ISO has standards that touch almost every industry in some way. Trying to meet all regulations and guidelines, especially across borders, is a challenge. The best way to meet these requirements is with a platform of digital systems that works across multiple industries.

GxP Software Solutions

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Document Control

No GxP software is complete without good document control. MasterControl Documents automates routing, follow-up, escalation and approval of documents. 

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Training Management

Under GxPs, employees must be trained and companies must record that training. MasterControl Training automatically sends out training tasks and records training.

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Corrective and Preventive Action (CAPA)

The CAPA process is difficult to handle without GxP software. MasterControl CAPA lets you launch a CAPA form from any other form, such as complaints. This minimizes human error and data entry problems.

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Audit Management

GxP software doesn’t do much good if you can’t easily show an auditor what you’ve been doing. MasterControl Audit streamlines audits and all related tasks.

GxP FAQs

What is GxP compliance?

GxP compliance refers to meeting the regulatory requirements and guidelines for good manufacturing practices, good laboratory practices, good clinical practices, or any other relevant GxPs in your industry.

What is a GxP system?

A GxP system is how a company goes about ensuring GxP compliance. This could include how they manage their SOPs, complaints or change control.

What is the difference between GxP and non-GxP?

Non-GxP generally refers to something that isn’t compliant or wasn’t designed with compliance in mind. For example, a software system that isn’t designed for regulated industries would be considered non-GxP.

Automated GxP compliance.

MasterControl has solutions for all GxP regulations to automate your business processes and keep you compliant.

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