Process validation requires the collection and evaluation of data from the design stage to commercial production, thus establishing scientific evidence that proves your process is capable of consistently delivering a quality product. In the past, this has traditionally been managed using paper-based documentation.

Unfortunately, there are many challenges in using traditional paper-based process validation:

  • A silo approach where there is no integration between process design activities (Stage 1), process qualification (Stage 2), and continued process verification (Stage 3)
  • Risk assessment and mitigation activities for attributes, parameters, and process designs are maintained in basic spreadsheets and/or paper documents without an easily accessible audit trail
  • The current manual approach is prone to a lack of visibility, data integrity issues, and noncompliance incidents
  • Manual and time-consuming planning of control strategy and documentation
  • Manual batch number identification for performance qualification
  • Inefficiencies and longer cycle times lead to delayed production
  • Control charts and statistical reports for annual product reviews must be manually prepared
  • Islands of information are lost in a sea of paper documents, databases, and file folders
  • Lack of visibility when it comes to data and the qualification statuses of equipment
  • Delays and errors caused by paper-based validation documents and manual protocol execution
  • Knowledge resides with only one person/group, leading to organizational dependency on personnel instead of processes
  • Process validation stages are disconnected and difficult to enable knowledge management process

Automated Process Validation Lifecycle

The ValGenesis VLMS automates the validation lifecycle by integrating all stages of process validation, from process design to qualification and continuous/continued process verification.

  • Our Process Validation Master Plan drives all stages of process validation and enforces the required studies and deliverables at every stage, with required dependencies between the studies and deliverables
  • Using risk assessment models, our VLMS helps to conduct risk assessment and a mitigation plan for process design, parameters, and attributes
  • Decision trees aid the user in determining the product group based on bracketing, matrix, and family approaches
  • Framework tools will determine the best validation strategy based on the product group and enforce required studies and deliverables as per the approved process validation master plan
  • Risk assessment approach is used to identify the number of batches to be taken as part of process performance qualification (PPQ), with required justification and approvals
  • Validation deliverables are electronically created, reviewed, and approved, eliminating paper from the validation process
  • Our VLMS provides real-time information on the validation statuses of your products
  • Electronic execution of the Process Batch Record (as part of stages 2 and 3) helps to monitor processes in real time
  • Our VLMS dynamically collects the CPPs, as per the predefined schedules, and updates the batch records to eliminate human errors and provide a higher degree of data integrity
  • Electronically perform trend analysis as part of validation reports, annual product quality reports, and analysis of CpK and PpK

Process Validation

Advantages of Digitizing Your Process Validation:

Paper-based process validation is ineffective, inefficient, time consuming, and expensive. With the ValGenesis VLMS, however, your organization can experience the time- and cost-saving benefits of implementing a fully compliant automated Process Validation Lifecycle process.

  • 100% electronic approach to the process validation lifecycle, in compliance to 21 CFR Part 11, Annex 11 and data integrity requirements
  • Compliance with FDA guidance on ‘Process Validation: General Principles and Practices’ published on Jan 2011
  • Enables cGMP regulations for validating pharmaceutical (drug) manufacturing processes to meet all the attributes they are intended to possess (21 CFR 211.100(a) and 211.110(a))
  • Automates the process validation lifecycle by integrating all process validation stages
  • Process validation is driven by the Process Validation Master Plan, using application tools such as decision trees, frameworks, templates, electronic execution, and matrices
  • Enforcement of validation standards and policies according to an approved process validation Master Plan
  • Fully integrated process validation with analytical method validation, cleaning validation, and equipment qualification
  • Reduced process validation cycle time and costs
  • Improved consistency as well as increased levels of compliance and data integrity in process validation

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Leading Global R&D-Based Pharmaceutical Company Chooses ValGenesis’s VLMS to Manage Validation Process
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