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Validation Life Cycle Management Systems (VLMS) in the Pharmaceutical and Biotechnology Industry

The pharmaceutical and biotechnology industry has been in need of a technological solution to fully automate the paper-based manual validation process. Unfortunately, the pharmaceutical and biotech industry has been slow to adopt and implement validation lifecycle management systems. This article will discuss the challenges related to manual validation and the technological solutions available to the pharmaceutical and biotech industry.

Paper-based validation processes do not provide the pharmaceutical and biotech industry with a cost-effective and cost-effective solution to manage qualification data and information during the validation life cycle. Paper validation documents such as plans, qualification protocols (IQ, OQ, PQ) and summary reports are typically stored in folders in a secure document archive. Binders do not provide a holistic and integrated view of data and information during the validation life cycle. During periodic review and revalidation activities, companies must be able to review and perform an objective and conclusive assessment of the validated state of the system. Paper documents and folders do not provide the ability to perform a built-in objective assessment of the validated state of the system because the data and lifecycle information reside on disparate systems such as folders, file folders, and databases.

During the execution of the validation protocols, the validation engineers have to perform a lot of inefficient manual activities, such as printing, dating and initializing all the attachments included in the executed protocol. These manual activities increase the compliance risk associated with Good Documentation Practice issues, data integrity, misplaced lost documents.

In post-execution processes, the validation protocol owner must walk through the facility routing the executed protocol for review and approval. All reviewers and approvers should review every page of the paper run protocol, including attachments and associated data, including calculated values. The post-protocol execution process is riddled with waste and inefficiencies related to the wait time associated with routing and reviewing protocols executed on paper. Executed protocols have many inefficiencies and waste, including the process of archiving folders and documents created and executed during the validation life cycle. The process of archiving validation documents is not cost-effective due to the cost associated with document control facilities that must manually store and search for validation executed in the archive.

In validation processes, creating a traceability matrix is ​​very challenging and time-consuming. Creating a paper-based traceability matrix requires validation resources to spend a significant amount of time tracking the system specification and the results of validation tests. Validation processes do not provide the ability to create a dynamic electronic lifecycle traceability matrix.

Data integrity is another challenge with paper-based validation processes. Paper validation documents are often misplaced and lost during the validation life cycle. Data integrity challenges with paper-based validation processes also include falsification and manipulation of information without any traceability or audit trail of data entry and changes.

Paper-based validation does not provide the ability to integrate change management with the process. The inability to integrate changes and validation activities during the life cycle is a major challenge of paper-based validation processes due to the inability to assess the impact of changes during the life cycle.

Validation lifecycle management systems eliminate all the challenges and inefficiencies found in validation processes. Validation lifecycle management systems eliminate and automate all manual validation activities, including the creation, review, approval, and execution of validation protocols.

Validation lifecycle management systems allow the ability to create a dynamic traceability matrix that fully automates this manual, inefficient, and time-consuming process. These systems eliminate the need to initialize, date, and seal all protocol attachments, significantly reducing cycle time and cost.

Lifecycle management systems address data integrity risk by providing fully traceable transactions that are audited across the system, including changes to expected results during electronic protocol execution.

In short, validation lifecycle management systems are a suitable, efficient, and cost-effective solution. VLMS provides an automated end-to-end for the industry. Validation Lifecycle Management Systems fully automates the validation lifecycle process for cleaning, processes, IT systems, and equipment validations. Paperless validation technology eliminates the challenges and inefficiencies found in paper-based validation processes.

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