Digital Signatures, Document Management, Esignatures, healthcare, Pharma, Security and Compliance

Gxp Compliance and Validation: How Going Paperless Saves Your Efforts

Paperless-GxP-Compliance

If you are running a business in life sciences or other regulated industries, you must be knowing what intensifying competition is. The shrinking margins, rapidly increasing product personalization and customization makes business processes even more complicated. Not only this, you must also be probably encountering the concept of GxP – one of the biggest concerns that pharma industry tries hard to address for ensuring the quality of their products. If implemented in the right manner, then delivering a safe and effective product is no more a challenging task.

So, Let’s Understand What Gxp is?

GxP is a general abbreviation for the “good practice” quality guidelines and regulations that were established in the U.S. by the Food and Drug Administration (FDA). The overall intent of these guidelines and requirements is to ensure that medicinal products, medical devices, biologics, and other food products are safe for consumption. In addition to this, there are regulations set to ensure the integrity of data used to make product-related safety decisions.

What Does “X” in GxP signify?

“X” is variable in the term GxP that defines a broad range of compliance-related practices such as:

  1. Good Laboratory Practices (GLP): It involves a set of standards for non-clinical laboratory tests and studies that are conducted for assessing the safety and efficacy of the product.
  2. Good Clinical Practices (GCP): A set of clinical trial regulations for the products that require testing on human subjects.
  3. Good Manufacturing Practices (GMP): A recommended set of practices by agencies for the authorization and control of the manufacturing of products.

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Each of these practices involves several product-specific requirements. It is mandatory for every pharma and life sciences organizations to implement these practices based on the

  • Type of products they make
  • The country in which their products are sold

 

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In addition to these good practices, there is another very important aspect of GxP, i.e. GxP Validation. Continue reading to get a detailed view of this aspect.

What is GxP Validation?

With technology and digital transformations, the manufacturers are rapidly optimizing medical devices and products manufacturing processes. They have stepped into the digital era in order to accelerate production and innovate new products. With this, the usage of computerized systems is on hike. These computerized systems need to undergo proper validation process. And under the Gxp regulatory compliance, this validation is referred to as GxP validation.

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While validating, there comes a major requirement of documenting each evidence that showcases that the system is operating as intended. This documentation is further classified into the following:

  1. Functional Requirements
  2. Traceability Matrices
  3. Operational Qualification (OQ)
  4. Functional Test Reports

All these are collectively referred to as “Validation Documents.” These documents, the scope of the testing, and the testing rationale need to be accomplished by every organization that comes under regulatory industries as these are crucial for passing any regulatory inspections.

The Traditional Way of Keeping Up with GxP Regulations!

The traditional way of meeting these regulations was by carrying out paper-based processes that, too, manually. This results in complicating new product introduction pipelines in the life sciences industries. Many companies are left behind the competition while continuously failing to deliver a safe and effective product.

However, there’s a simpler solution to optimize manufacturing processes: eliminate paper production records and digitize the process. Almost every organization is now undertaking such practices as these regulations hold the potential to make or break a business.

Challenges Organizations Face with GxP Regulations

GxP-Regulations

In order to ensure that the quality of the goods or services is consistently high, organizations need to focus on the following areas:

  • Traceability
  • Accountability
  • Integrity
  • Accuracy
  • Availability

You will get a detailed information on these areas and a right way to do it at link

How MSB Docs is an Ideal Solution?

MSB Docs – as a smart document solution, makes GxP compliance easier than ever. Most MSB clients are pharmaceutical giants and are regulated by FDA – 21 CFR Part 11. Be it manufacturing, testing, or validating processes, today they have gone paperless with MSB Docs. Its ability to generate accurate and complete copies of records in both human-readable and electronic form make it the perfect fit for fulfilling inspection, review, and copying requirements by the agencies.

Smart-Document-Solution

Apart from just offering electronic signatures, digital signatures, and online document transactions, the following MSB Docs features will help you understand what makes us stand out from the crowd:

  • MSB Docs offers server-based UTC time synchronization
  • There are customizable workflows to support business functions
  • There is built-in timestamp tagging in the platform
  • Each transaction records UTC time stamp even it is for creation, modifications or deletions
  • MSB Docs offers the ability to export Audit trail with UTC timestamp
  • All these documents stored in the cloud have a configurable retention period
  • Integration services to make MSB part of enterprise business process automation
  • Validation of user credentials before accessing the system or before signing the document.
  • Team Room facilitates a group of users to plan, track, and collaborate in a central and consolidated view.

The list of features does not end here as there are many more that you will identify once you get into the system. So, book a demo with us now!

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