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, scanning, storing and archiving paper-based equipment validation documents. There is a significant amount of challenges and compliance risk associated to paper-based equipment validation. The compliance risk related to paper-based equipment validation include the following:
Inability to enforce and follow approved procedures
Difficult to enforce and execute against the equipment validation master plan
Unable to enforce consistency
Challenges related to standardizing and harmonizing the validation process across sites
Good Documentation Practices issues
Lost and misplaced records
The inefficiencies and high cost associated with paper-based equipment validation is related to the following manual activities
Executing and scanning validation
Document control resources
The inefficiencies that negatively impact paper-based equipment validation processes also create business risk which includes the following
Paper-based equipment validation is very challenging because it is a very inefficient, time consuming process that requires a significant amount of resource commitment from the validation and document management teams. Paper-based equipment validation creates delays in releasing critical equipment for manufacturing operations. In paper-based equipment validation data and information is not readily available for review and assessments during the lifecycle because it resides in binders that fail to provide data integration and a centralized repository of equipment validation records
Validation Lifecycle Management Systems provide a solution to eliminate all the inefficiencies that plagued paper-based equipment validation processes. Validation Lifecycle Management Systems eliminate paper based equipment validation protocols and enable the ability to perform electronic executions, a centralized repository of data and information during the lifecycle of GMP equipment.
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.