ValGenesis Inc.

ValGenesis Inc.
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ValGenesis Inc.

 •  February 5

Data integrity is a critical regulatory requirement for the life science industry that is applicable to validation lifecycle. All information data and records generated during validation and the lifecycle of GMP systems is subject to data integrity regulatory requirements. Data integrity refers to the accuracy and consistency of stored data,...

ValGenesis Inc.

 •  January 17

Requirements Traceability Matrix is a regulatory requirement for the life science industry. The Requirements Traceability Matrix (RTM) is a document that links requirements throughout the validation process. The purpose of the Requirements Traceability Matrix is to ensure that all requirements defined for a system are tested in the test protocols....

ValGenesis Inc.

 •  November 20, 2017

Commissioning and Qualification is a critical regulatory requirement for the life sciences industry. The purpose of commissioning and qualification is to ensure and provide documented evidence that facilities and equipment are qualified based on their intended use. Commissioning and qualification typically. includes the following activities and...

ValGenesis Inc.

 •  November 10, 2017

How technology can ensure adherence to regulatory requirements Two worlds are colliding and it’s very exciting because they promise to give birth to a promising new future. The two worlds are Technology, with blockchain, and Regulatory, with data integrity. Combined the two appear to be the ingredients that, when combined, will solve many problems...

ValGenesis Inc.

 •  October 17, 2017

In 2011, FDA published a new guidance for the industry on Process Validation: General Principles and Practices. This guidance aligns process-validation activities with the product life-cycle concept which moves from the current 3 batch process to a 3-stage process requires significant changes with traditional validation process and approach....

ValGenesis Inc.

 •  September 28, 2017

During the operational phase of Clean In Place (CIP) cycles companies rely in manual methods to determine the success of routine cleaning process. Some of these manual methods to determine the success of the routine cleaning cycles rely on performing very inefficient activities that are very costly and don’t have adequate cycle times. Some of...

ValGenesis Inc.

 •  September 19, 2017

The partnership between ValGenesis and VTI creates a fully comprehensive and innovative approach towards providing validation services using an integrated paperless validation lifecycle management platform. Life science companies will benefit greatly from VTI’s validation expertise and their knowledge of the ValGenesis VLMS platform. “We are...

ValGenesis Inc.

 •  August 30, 2017

Validation is a global regulatory requirement in the life science industry. The purpose of validation is to establish evidence that systems and processes will consistently yield results that meet predetermined specifications. The goal of the validation process is to ensure that systems and processes work as intended and they meet user...

ValGenesis Inc.

 •  August 22, 2017

San Francisco, CA, August 22nd 2017, ValGenesis Inc., the global leader in Enterprise Validation Lifecycle Management Solutions (VLMS), is pleased to announce the issuance of a patent on paperless validation, #9,720,687. The patent granted by the U.S. Patent and Trademark Office (USPTO) focuses on ‘Validating and Maintaining Respective Validation...

ValGenesis Inc.

 •  August 11, 2017

Cleaning Validation is a critical regulatory requirement in the pharmaceutical, biotechnology and medical device industry. The purpose of cleaning validation is to establish evidence that the cleaning process will consistently yield results that meet predetermined specifications. The goal of the cleaning process is to remove the following: All...