ValGenesis Inc.

ValGenesis Inc.
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ValGenesis Inc.

 •  October 17

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

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

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

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

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

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...

ValGenesis Inc.

 •  June 30

In the life science industry, all computer systems with GMP impact must be validated. Computer System Validation is intended to provide documented evidence that a computer system meets documented user requirements. User requirements need to be traceable to individual validation test using a traceability matrix. Unfortunately creating a...

ValGenesis Inc.

 •  June 29

In the life science industry, all computer systems with GMP impact must be validated. Computer System Validation is intended to provide documented evidence that a computer system meets documented user requirements. User requirements need to be traceable to individual validation test using a traceability matrix. Unfortunately creating a...

ValGenesis Inc.

 •  May 25

Leveraging Technology to Address the ALARP vs AFAP Challenge It is a regulatory requirement for Medical Device companies to perform Risk Management and provide documented evidence to demonstrate compliance with regulation and a company’s own Quality Management System (i.e., Policy & Standard Operating Procedures). Expectations are stipulated in...

ValGenesis Inc.

 •  May 5

In the pharmaceutical, biotechnology and medical device industry equipment validation traditionally is a manual inefficient paper-based process that is plagued with bottle necks and high cost. The inefficiencies found in traditional equipment validation are related to manual activities such as routing documents for review, approval, printing,...