What are the current trends in validation documentation and reporting?

Increased use of automated validation tools, adoption of risk-based approaches, and a shift towards electronic documentation and reporting are current trends in validation practices.

Risk-based approach ensures that resources are being effectively utilised. Risk-based approach ensures time is spent on higher risk items to ensure product quality and patient safety. If a risk is treated as lower risk, a justification or rationale is required. As explained in GAMP 5 version 2, Critical Thinking is required to adopt risk-based approach and to ensure effective utilisation of resources.

Application of Risk-based approach can help to narrow down the focus of the documentation. It starts with assessing the criticality and complexity of the system to be implemented. A standard heat sealer can have smaller validation package than a custom made packaging machine. Evaluating the functions helps to define what kind of evidence you need, where you can you simple checklist, statement or screenshots, system logs. Also helps to define how detailed/rigorous test scripts are needed.

The risk-based approach to validation of GxP systems, i.e. systems which are used for activities which are regulated under GxP (e.g. GLP, GMP, GCP, GDP, GPvP), is primarily about protection of the patient and product quality. Guidance on quality risk management is provided in ICH Q9. This requires "scientific knowledge" or in practical terms a good understanding of the process for which the system is to be used. It also recognises that activities should be scaled based on risk, including the risk assessment process itself. The risk-based approach to computer systems validation promotes more rigorous testing of systems/functionality with Direct impact on patient safety or product quality than those with Non-direct or little impact.

In my perspective, classifying risks is essential for effective resource allocation and prioritization. This approach guarantees that critical or high-risk areas receive the necessary focus and validation efforts. It's important to recognize that high and low-risk systems should not be treated the same way. Following the principles suggested by GAMP and CSA to perform risk-based validation makes sense. With a risk-based approach, we can channel our resources where they matter the most – high-risk areas. This not only optimizes resource utilization but also aligns with regulatory expectations. Regulators expect controls to be in line with the level of risk, and a risk-based approach is the means to meet these expectations.

On the last few projects I did as a CQV manager, I have implemented the Kneat software as the pilot for every separate customer. It is a database with records, that appears as (web)pages if you call them. Although in general that works great, the mistake has been made to connect/link the records: Requirements in the URS are linked to IQ or OQ tests, to check if they are fullfilled. The issue is that the link breaks if for example the URS is updated. It means you would then have to update the full train of a testpack. Sometimes that makes sense: It might be necessairy. But often an assesment clarifies it does not impact later protocols. With electronic linking you are still stuck with broken links..

One of the best improvements in the field of GxP computer system validation in recent years, is the recognition that the software tools used to help validate computer systems, don't generally need to be validated. They should be assessed for their adequacy and core functionality can be verified as working correctly in the environment where it is used. These commercially available systems can be used in place of paper based validation and validation records stored electronically. See GAMP 5 2nd Edition Appendix D9 - Software Tools for more details.

In my experinece paper based validation document will survive with the help of electronic signatures. EMDS systems also contributes to keeps alive the word documents. Their big advantage is their ability to share the validation documents within a company. This helps to share knowledge, best practice; can increase transparency and standardization. I am struggling to find the effective way to use a general AI for validation documentation purpose. It can be used to generate URS, test scripts etc.. but the output still needs to be reviewed. Also while you are struggling to create the test scripts, you learn a lot about the system. But automation is important if you use documents and spreadsheets. Use it to generate traceability, checklists etc.

While the article accurately highlights the benefits of automation and digitization in validation documentation, it's crucial to note that the use of AI and ML tools requires rigorous qualification to ensure their output is accurate and complete for any Computer Systems that leverage the output. This involves testing the algorithms used, the data input, and the output generated. It's also important to establish a robust system for monitoring and maintaining these tools to ensure ongoing compliance with regulatory standards such as 21 CFR §11 and GAMP5.

Automation and digitization are not just trends; they are essential components in modern Computer System Validation (CSV). I've seen firsthand how these tools can streamline validation processes. Electronic document management systems (EDMS) and validation lifecycle management software (VLMS) are critical in ensuring compliance with regulatory guidelines such as 21 CFR §11. Additionally, the use of AI can significantly enhance risk assessments and ensure a more robust validation process. It's important to leverage these technologies to maintain a competitive edge and ensure regulatory compliance.

Agile and lean methodologies support the ability to adapt quickly to changing regulations or compliance standards. Teams can incorporate new or missed requirements into validation documentation efficiently.

As per my experience, implementing Agile in GxP requires adapting Agile practices to meet regulatory demands. Key steps include defining clear documentation requirements, conducting frequent validation and testing, integrating rigorous change control, risk management, and cross-functional collaboration are important. Team training in GxP standards is essential, and alignment with regulatory compliance is non-negotiable. Seeking expert guidance for the integration of Agile practices in a GxP environment is advisable to ensure product quality and regulatory adherence.

Incorporating agile and lean methods in computer system validation (CSV) aligns with the dynamic nature of the pharmaceutical and biotechnology industries. I can attest that these methods enhance efficiency by enabling a more flexible approach to validation. Iterative development allows for continuous integration and testing, which is crucial for systems that must adhere to strict regulatory standards. Additionally, by prioritizing customer feedback and value stream optimization, agile and lean methods ensure that the validation process remains focused on delivering high-quality, compliant systems that meet end-user needs. But bear in mind that Release Management and Reliability Engineering can be tricky in DevOps and Agile SDLC processes.

Incorporating agile and lean methods in computer system validation (CSV) is a forward-thinking approach that aligns with the dynamic nature of the pharmaceutical and biotechnology industries. I've seen how iterative development and continuous improvement can significantly streamline validation processes. By focusing on customer feedback and value stream optimization, we can ensure that validation activities are not only compliant with regulatory guidelines like 21 CFR §11 and GAMP5 but also efficient and cost-effective. This approach is particularly beneficial when validating complex systems such as clinical trial management systems or bespoke computer systems.

This is of paramount importance though not seen by many in the grand scheme of achieving computer system validation. Better environment to communicate, share ideas, brainstorm are vital for a happy outcome for validation.

In the context of Computer System Validation (CSV), effective collaboration and communication are crucial not only for the quality of validation documentation but also for regulatory compliance. Inaccurate or incomplete validation documents can lead to non-compliance during FDA inspections and Sponsor audits. Therefore, a robust communication strategy can help to ensure that all requirements are accurately captured and documented, mitigating the risk of non-compliance. Furthermore, it can foster a culture of accountability, promoting adherence to regulatory guidelines such as 21 CFR §11, FDA/EMA regulations, ICH-GCP, and Eudralex.

Incorporating standards and best practices in validation documentation and reporting is crucial for ensuring compliance with regulatory requirements. As an experienced professional in the pharmaceutical and biotechnology industry, I can attest to the importance of adhering to standards such as ASTM E2500 and IEEE 1012, which provide a structured approach to validation activities. These standards, along with FDA and EMA guidelines, help organizations maintain a high level of quality assurance and meet the stringent demands of regulatory inspections.

I can attest to the importance of leveraging risk-based approaches and automation to enhance the efficiency and accuracy of validation processes. Agile and lean methods, coupled with effective collaboration and communication, are key to adapting to changes swiftly. As technologies evolve, e.g., AI/ML, Cloud, DevOps, and guidelines update to include them, firms must be continuously learning, attending conferences, collaborating with their Regulatory groups, and updating SDLCs and templates to ensure validation teams are well-equipped to handle sponsor audits, regulatory inspections, and the complexities of computer system validation.

The current trends in validation documentation and reporting are moving towards a more risk-based approach, with an emphasis on automation and digitization. This is largely driven by the CSA (Computer Software Assurance) approach, which focuses on ensuring the reliability of software without necessarily testing every single function. It's a shift from the traditional validation approach, which can be time-consuming and resource-intensive. The CSA approach, when combined with agile and lean methods, can significantly improve efficiency and effectiveness in validation processes. Furthermore, the use of standards and best practices, continuous improvement, and learning are also key in ensuring the robustness of the validation process.

The recent trends in the validation documentation in the GMP environment are lean, agile, automated and standardised via different tools. Organisations are using the automated tools offerred via different companies for generation of validation documentation. There have been focused towards the availability of lean, simplified and standardised templates of validation documentation.