Enabling Efficiency, Cost Reduction and Compliance Using a Validation Lifecycle Management System
Validation is a critical regulatory requirement for the Pharmaceutical industry. Validation is an important element of the 3-stage lifecycle approach described in the FDA Process Validation guidance document published in January 2011. The 3-stage approach includes Stage I Process Design, Stage 2 Qualification and Stage 3 Continued Process Verification. The lifecycle approach promotes the integration of the 3-stages where information and data are readily available during the entire process. The data generated during the entire lifecycle can be ud to reduce the amount of validation and revalidation activities.
讲话紧张During the validation process companies generate a significant amount of data and information related to the lifecycle of GMP regulated systems. The traditional validation process is executed using paper-bad records such as Validation Plans, System Specifications, Risk Asssments, Protocols and Validation Summary Reports. During the lifecycle of GMP systems a significant amount of paper-bad records is generated that require storage and archival. Unfortunately, the cost of document storage and archival is very high during the entire lifecycle. The traditional validation process is quite inefficient and cost effective due the significant amount of inefficiencies related to manual activities such as printing, scanning, executing, and routing documents for review and approval.
This whitepaper summarizes the challenges found in the traditional validation process and the benefits achieved by implementing Validation Lifecycle Management Systems (VLMS).
What is Wrong with the Traditional Validation Process?
The traditional validation process has a significant amount of limitations, constraints and challenges and they include compliance and business risk. The compliance risk is related to the following challenges:
• Failure to follow approved procedures
• Difficult to enforce the approved validation procedures and validation master plan
• Lack of consistency
• Difficult to standardize and harmonize the validation process across sites
• Documentation issues
价格用英语怎么说• Lost and misplaced records
• Regulatory obrvations
In the traditional validation process companies rely on approved procedures and their associated controls with the intent to meet regulatory requirements and provide consistency. In a manual paper-bad process companies rely on the ability of the procedure to clearly and concily articulate the process requirements and instructions about how to meet required controls. Unfortunately, not all validation procedures are well written and often fail to clearly communicate the process requirements and how to execute and complete validation activities. Another challenge and risk are that companies rely on people making an accurate interpretation and their ability to follow approved validation procedure which can have a negative impact on compliance.
Paper-bad validation documents are often lost and misplaced during the lifecycle of GMP systems therefore creating a compliance risk. During the execution of validation activities in paper-bad documents issues related to Good Documentation Practices are very common due the significant amount of manual entries needed in protocols and attachments. The compliance challenges described above lead to issues during audits including obrvations from regulatory agencies.
In the traditional process it is very challenging to have a 3-stage lifecycle approach where validation i
s integrated with stage I & II. This is related to the inherit limitations of relying on a manual paper-bad lifecycle process where there is a lack of integration of data and information. This challenge has a negative impact on the ability to effectively u, access and manage critical lifecycle data.
In addition to the challenges described above the traditional validation process have a significant amount of business risk. The business risk is related to the significant amount of inefficiencies found in the traditional validation process. The inefficiencies are related to the manual activities performed in the traditional validation process such as printing, scanning, executing and archiving validation paper-bad records. The manual activities found in the traditional validation process have a negative impact on cost due inefficient cycle times. The document management cost is very high during the entire system lifecycle due to the amount of resources required to manage, store and archive validation paper-bad documents.
Due to the inefficiencies and inadequate cycle times found in the traditional validation process there is a significant amount of business risk which includes the following:
• Loss revenue
• Higher operational cost
• Higher expens (document storage, archiving, retrieval, resources)
• Inability to relea manufacturing equipment
• Delayed production schedules
什么是同等学历Electronic Document Management Systems — The Solution to the Inefficiencies Found in the Traditional Validation Process?
Electronic Document Management S ystems (EDMS) are widely ud in the pharmaceutical industry to manage the lifecycle of controlled documents such as procedures, product specifications, technical reports and sometimes validation documents. EDMS systems enable the ability to create automated workflows for the review and approval of controlled documents. The systems also provide the ability to nd electronic notifications to stakeholders involved in the review and approval of controlled documents. EDMS systems provide a significant amount of benefits against a paper-bad document management process.
Unfortunately, EDMS systems are not an adequate solution to manage validation documents during the system lifecycle. Although EDMS systems provide the ability to automate the review and approva
l process of controlled documents they fail to provide the ability to execute electronically validation documents.
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EDMS systems also fail to provide the ability to generate a dynamic traceability matrix and to integrate all records and information generated during the system lifecycle. EDMS systems partially automate the lifecycle of validation documents and they lack the efficiencies found in Validation Lifecycle Management Systems. EDMS systems fail to provide full lifecycle management capabilities.
Due to the inability to provide electronic execution EDMS systems provide a hybrid solution which includes paper-bad and electronic records. The limited capabilities offered by EDMS systems create similar challenges as tho found in the traditional paper-bad validation process. Managing the validation process using EDMS system have the same business and compliance risk found in traditional paper-bad validation process. EDMS systems are inefficient and not an adequate solution due to the following issues:
• Need to print protocols for execution
• Scanning documents back in the system
• Routing the executed paper document and related data for final review
• Routing the executed paper document and related data for final approval
Ap p lication Lifecycle Management — The Solution to the Challenges Found in EMDS Systems?
成绩单英文
Application Lifecycle Management applications are t of software tools for application development and automated testing. It includes tools for requirements management, test planning and functional testing, performance testing, developer management and defect management. ALM is intended to provide Information Technology departments with a centralized application management platform for managing and automating within and across application teams and throughout the complete process of developing an application.
Application Lifecycle Management tools are designed to support the lifecycle of software applications. Unfortunately, the tools are not designed to manage the validation lifecycle of manufacturing process, product, cleaning, equipment, analytical methods and instruments. Application Lifecycle Management tools are unable to provide the benefits found in Validation Lifecycle Management Systems.
Enabling Efficiency and Cost Reduction with the Imp lementation of a Validation Lifecycle Management System
普林斯顿大学Validation Lifecycle Management Systems provide an electronic tool that is designed to manage and integrate all validation lifecycle activities. Validation Lifecycle Management Systems enable technology that reduces cycle time by eliminating the inefficiencies found in the traditional paper-bad and hybrid validation process. The technology enables the ability to eliminate the inefficient non-value activities found in more traditional validation process. The technology also enables full integration of the 3-stages of the lifecycle which enables data, information and knowledge to be readily available in the system.
Validation Lifecycle Management Systems provide a lot of benefits to the industry and they include the following:• Efficient cycle times
• Full lifecycle management
• Full integration of the 3-stage lifecycle approach
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• Reduced Validation effort while increasing compliance
• Electronic protocol execution
• Approvals are tracked and alerts through e-mail are nt out to approvers
• Single repository (instance) for all validations across multiple geographical locations
• Enables standardization and consistency across multiple geographical locations
• Enable real-time metrics at the system and ur level provides full visibility across the entire organization
Validation Lifecycle Management Systems enable efficiency and cost reduction by providing the following integrated functions not available in other systems:
• Requirements Management
• Dynamic Trace Matrices
• Risk Manager
天津二级建造师报名• Validation Plan
• Protocol Developer
• Test Executor
• Off-line Executionfon
smallint• Exception and Deviation Management
• Equipment Inventory
• Decommissioning/Retirement
Although Validation Lifecycle Management Systems provide a significant amount of benefits including cost reduction and efficiency improvements the pharmaceutical industry has been very slow in adopting and embracing this technology. Typically, companies are more interested in investing on more traditional technology like Electronic Document Management S ystems that are perceived to be capable to automate most of the validation process. Unfortunately, as described earlier in this document EDMS systems are unable to manage efficiency the validation lifecycle. Due to the high cost associated with traditional validation process recently the industry is showing a significant amount of interest in Validation Lifecycle Management Systems.
ValGenesis is the global leader in providing 100% paperless Electronic Validation Lifecycle Management System that help tracks status of activities and automates the entire validation process. ValGenesis expedites the validation lifecycle process and eliminates inefficiencies that plague paper-bad validation process. The ValGenesis system provides complete visibility of all GxP systems and process with real time validation status, instant access to validation data and documents, therefore improving efficiency and enhancing consistency throughout the validation lifecycle process. This results in a reduction of validation cycle time and validation costs by 50%.
Author: Ivan Soto, Director Client Engagement & Product Strategy, ValGenesis Systems
