Professional Services

Paperless validation for Life Sciences projects

Pharmaceutical organizations in the life sciences industry face challenges in developing and maintaining data integrity due to complex validation documentation. Maintaining data consistency, accuracy, and integrity across many documents is challenging. The validation processes, which have been using paper-based systems, require a change that eliminates process inefficiency, waste of time and loss of data, or more time spent on seeking relevant data.

The following are some of the challenges with paper-based validation:

  1. Validation paper records: There can be thousands of pages of validation paper records, including objective evidence that need to be printed, reviewed by different departments, and physically signed with a date and time stamp.
  2. Document Management: Document storage and retrieval is a very challenging task. For example: test execution, objective evidence reviews, and approval processes consume more time.
  3. Reusability: Everything needs to be reproduced, there is no option to reuse in the manual way of executing validation projects.
  4. Traceability: Creating a Requirement Traceability Matrix (RTM) is not an easy task and consumes a lot of effort as linking URS / FRS / DS with other deliverables is completed in a manual way.
  5. Project execution: Sequential way of project execution. Adaption of agile parallel ways of execution and implementation is a challenging task.
  6. Human error: Paper-based validation may also be prone to human error. It may suppress innovation, increase compliance risk, and hinder time to market. These inefficiencies cost regulated companies tens of millions of dollars annually.

A solution to the paper-based validation is the Validation Lifecycle Management System (VLMS), which is designed to manage the entire validation lifecycle electronically and remove the inefficiencies that plague paper-based processes. This 100% paperless validation solution reduces the cost of validation by optimizing and stabilizing existing processes and procedures. Validation lifecycle processes have improved 40% or more simply by implementing the VLMS.

With an electronic validation lifecycle management system, the user can:

  1. Enforce standard validation processes through frameworks
  2. Ensure document consistency through template management
  3. Associate validation tasks with change requests and risk assessments
  4. Manage and assess risk at the system and functional level
  5. Generate ad hoc reports; build reports quickly and easily
  6. Access validation data in real-time
Validation Lifecycle Management System

VLMS – Capabilities and Modules

Features of Validation Lifecycle Management Systems:

Below are some of the general features of VLMS. All of these modules are defined as per applicable Clients Quality Manufacturing System (QMS) procedures, and procedures on computer system validation.

  1. Administration module allows an administrator to create role, department, title, user, set-up security profile, access control, and audit trail.
  2. System Manager module allows the set-up of user groups and users, define functional roles, and workflows.
  3. Creation of workflows define standard review and approval routing procedures. Workflows can be applied to one or more functions such as Risk Management, Test Management (Design & Execution), and document approval in the system.
  4. Assessment module allows users to conduct an assessment for an entity by grouping, framework (deliverables), entity and bind with an entity type.
  5. Validation framework and associated deliverable can be managed as per a RACI matrix and has the ability to assign development, review, approval, and execution activities.
  6. Project module allows users to define required validation deliverables that must be completed for any entity, and shall be considered as per the validation plan or procedure.
  7. Requirement module allows requirement creation, impact assessment, traceability model and review & approval.
  8. Content Manager module allows template creation, binding it to category, subcategory, entity, authoring task, document creation, development, mapping, review & approval.
  9. Execution Manager module allows execution task assignment, electronic execution, discrepancy creation, review & approval.

The following are some snapshots of key functionalities performed from a validation perspective:

  1. Administration:

2. Assessment: Perform Assessment

3. Content Manager: Initiate and Assign Document Authoring to Author

4. Execution Manager: Assign and Perform Electronic Test Execution

The benefits of “paperless” go beyond just paper—it is about digitization, collaboration, analysis, scalability, and total business performance:

  1. Less paper waste and less storage costs
  2. Increase in productivity
  3. Smarter change control and revision tracking
  4. Improved collaboration and communication
  5. Smarter task and team management
  6. Recyclable and reusable content
  7. Streamlined review and approval process
  8. Faster search and retrieval
  9. Pain-free inspection and audit
  10. Flexible system scalability

A Validation Lifecycle Management System serves as a key foundation for managing compliance-based validation activities and deliverables in life sciences and pharmaceutical companies. The solution is also compliant with U.S. FDA 21 CFR Part 11 and EU Annex 11 regulations.

The OpenText™ Professional Services team have years of experience working with Validation Lifecycle Management Systems and have performed validation activities successfully during the implementation of OpenText™ Documentum™ for Life Sciences for pharmaceutical organizations.  Contact us to speak to an expert.

Author: Elangovan Udayakumar – Elango is a Lead Consultant in OpenText Professional Services in APAC. He is a Computer System Validation professional, having a wealth of experience that spans across R&D IT, Manufacturing, S&M IT and Commercial IT work streams in the Life Sciences domain. He is an expert in managing, controlling, and implementing end-to-end software validation life cycles.

Professional Services - Industry

The Professional Services Verticals team focuses on specific industry processes, often within regulated industries e.g. Life Sciences, Government, Energy & Engineering. The team helps organizations within these industries find the best solution for them and consists of certified experts with many years of industry domain expertise. The team operates on a global basis leveraging predefined industry solutions based upon best practices.

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