For pharma and medical device companies, “validation” of automated systems is typically expensive and cumbersome. And it’s a process that delays the implementation of new systems and processes.
Regulatory requirements require that organizations be able to demonstrate that their software systems are fit for their intended use, operate as expected, and meet regulatory standards. Traditionally, validation has been a labor-intensive process involving extensive documentation, repetitive testing, and manual verification. As I said, it is a process that takes a lot of time and resources, sometimes requiring as much time as the implementation process itself for a new software system.
What Drives the Need to Validate Processes?
The concept of validation dates back to the early days of computerized systems in regulated environments. The specific requirement for the validation of systems is tied directly to Regulatory Compliance. Agencies like the FDA and EMA have established clear expectations for validation and qualification. For example, here’s a comprehensive list of FDA guidance documents related to software, equipment, and analytical procedure validations:
- General Principles of Software Validation: Provides comprehensive principles for validating software used in medical devices or in the design, development, and manufacturing of medical devices.
- Computer Software Assurance for Production and Quality System Software: Introduces a risk-based approach to software validation for production and quality systems, emphasizing confidence in automation.
- Quality System Regulation (21 CFR Part 820): Includes requirements for validating software used in production and quality systems.
- Process Validation: General Principles and Practices: This covers the validation of equipment and processes, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
- Analytical Procedure Validation: Analytical Procedures and Methods Validation for Drugs and Biologics: Focuses on validating analytical methods to ensure accuracy, precision, and reliability in drug and biologic development. Access it here: Analytical Procedures and Methods Validation for Drugs and Biologics
- Q2(R1) Validation of Analytical Procedures: Text and Methodology: Combines Q2A and Q2B guidelines for validating analytical procedures, emphasizing methodology and characteristics.
- Q2A Text on Validation of Analytical Procedures: Discusses characteristics for consideration during validation of analytical procedures.
The EMA has a corresponding set of guidance documents requiring and specifying the validation of systems:
- EudraLex – Volume 4 – EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use – Annex 15: Qualification and Validation: This annex provides comprehensive principles for the qualification and validation of facilities, equipment, utilities, and processes, including automated systems.
- EudraLex – Volume 4 – EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use – Annex 11: Computerised Systems: This annex explicitly addresses the requirements for computerized systems used in medicinal product production and quality control.
- Guideline on process validation for finished products – information and data to be provided in regulatory submissions: This guideline provides guidance on the process validation information and data expected in regulatory submissions for finished drug products.
In addition to those specific guidelines, adherence to industry best practices as outlined in GAMP 5 (Good Automated Manufacturing Practice) provides a framework for a risk-based approach to computer system validation that aligns with these regulatory expectations.
From Paper to Automated Validation Systems
Initially, validation was a paper-based process, requiring physical documentation of test plans, test scripts, results, and approvals. This approach was time-consuming, prone to errors, and required a significant investment of resources. I have seen proposals where the cost of validation was as much as the cost of the initial installation and configuration of the system.
Of course, organizations use spreadsheets and document management systems to streamline validation efforts. While these tools improve organization and record-keeping, they do little to reduce the manual burden of testing and documentation. For some time, it has been clear that the industry has needed a paradigm shift—one that would reduce time, increase accuracy, and improve compliance.
In response to the market need and advances in software technology, automated validation platforms that replace manual processes with intelligent, software-driven testing and documentation have come onto the market. These solutions integrate with life sciences software systems, automating test execution, data capture, and reporting. Automated validation dramatically reduces the time and resources required for validation. What took weeks or months can now be completed in days or hours.
Beyond saving time and resources, automated validation systems deliver other significant benefits:
- Efficiency Gains – Automated validation dramatically reduces the time and resources required for validation.
- Improved Accuracy – Manual validation is prone to human error. Automation ensures that every test is executed consistently and that results are accurately recorded.
- Regulatory Compliance – Automated tools generate complete, audit-ready documentation, reducing compliance risks and ensuring alignment with regulatory standards.
- Cost Reduction – By streamlining validation, companies can reduce labor costs and reallocate resources to higher-value activities.
- Scalability – As companies implement more software solutions, automated validation ensures that compliance can keep pace without an exponential increase in workload.
At Scigeniq, We Embrace Automated Validation
At Scigeniq, we have long recognized the transformative impact of automated validation. That’s why we have a strategic partnership with ValGenesis, a leader in validation lifecycle management. ValGenesis’ Validation Lifecycle Management System (VLMS) digitizes the entire validation process, from installation qualification (IQ) to operational qualification (OQ) and performance qualification (PQ). By automating data collection, testing, and documentation, VLMS ensures efficiency and compliance at every stage.
In addition to recommending ValGenesis to our clients, we also rely on VLMS as our own internal validation system. This commitment ensures that our validation processes align with industry best practices, delivering regulatory confidence and operational excellence.
Automated validation platforms like ValGenesis VLMS are revolutionizing how companies approach compliance, making the process faster, more accurate, and less resource-intensive. At Scigeniq, automated validation tools and processes are just one example of our commitment to leveraging the best tools available—both for our clients and our own internal systems—to drive continuous efficiency improvements and ensure compliance with regulatory requirements.