Factorytalk is pleased to join “ISPE Indonesia Annual Conference: Technology Innovation – Adhering to Ethical Behavior and Ensuring Patient Safety” on 6-7 June 2023. The conference gathered more than 100 participants from local and international experts, regulators, practitioners to discuss the topics and enjoy networking.
At the Factorytalk booth, we showcased our cutting-edge products and services with live demos to visitors. It was a pleasure discussing our offers with you and addressing any questions you may have had.
Factorytalk Speaking Sessions
The two days conference had our experts to have speaking sessions and share our insights as follows:
David Margetts
ISPE co-lead validation 4.0 and CEO/ co-founder of Factorytalk
Track 5: Pharmaceutical Miscellaneous Topics
Topic: Computer System Validation (CSV) – Good Practice Update – ISPE GAMP 5 Second Edition
Download a free copy of our presentation here:
Manuh Pitasari
Product Manager of Factorytalk
Track 2: Technology Innovation
Topic: Enabling Digitalisation in SEA Pharma Manufacturing
Download a free copy of our presentation here:
Q&A
Our speaking sessions received a lot of interest and active participation. Your thoughtful questions, insightful comments, and interactive contributions enriched the sessions.
Why Batchline:
- Build on the latest technology stack which allow more possibility for integrations
- Affordable and scallable compared to traditional MES: Client only pay what they need
- Fast Implementation
- Easy to use and self service model: it means client does not rely heavily on Factorytalk just to operate a system and make configuration changes
- Consulting and Implementation delivered and supported on timezone with local Indonesian resources with international Pharma IT & CSV experience 10 years + all over the world
- Factorytalk provide Client a one-stop-shop for digitisation with best in class solutions and services
There are several challenges in implementing an EBR system:
- Mindset shift: Moving from traditional paper-based record to an electronic system requires a change in mindset and work culture. Some employees may be resistant to change or may feel uncomfortable with new technology. Overcoming this challenge involves effectively communicating the benefits of EBR systems, addressing concerns, and providing adequate training and support to help employees adapt to the new system.
- Management buy-in: Convincing management about the benefits and value proposition of EBR systems is crucial for successful implementation. Management may have concerns about the initial investment, disruption to existing processes, or resistance from employees. To address these concerns, it is important to present a clear business case highlighting the potential return on investment, improved operational efficiency, regulatory compliance advantages, and long-term cost savings.
- Stakeholder alignment: Implementing an EBR system requires collaboration and alignment across multiple departments and stakeholders, including production, quality assurance, IT, and regulatory compliance. It can be a challenge to ensure that everyone is on the same page and understands the purpose and benefits of the EBR system. Effective communication, regular meetings, and involving stakeholders early in the process can help build consensus and facilitate smoother implementation.
Moving to an electronic batch record (EBR) system offers several benefits in terms of compliance and efficiency. From a quality perspective, eBR improves data integrity, compliance, and right-first-time rates, leading to increased productivity. The system automates control and checking processes, allowing employees to focus on problematic areas instead of reviewing records individually. The review-by-exception function is particularly useful, accelerating time to market.
CSV is a process to achieve and maintain compliance of computerized system with applicable GxP regulations and fitness for intended use by adopting the principles, approaches, and life cycle activities within the framework of validation plans and reports, and the application of appropriate operational controls throughout the life of the system.
GAMP5 2nd Edition does not prescribe any specific terms for the validation activities and deliverables, particularly in specification/testing. Different suppliers and regulated companies may use own/other terms and is often a source of confusion or overlap. The focus is on the goal of the CSV deliverable (accept and release the system for use), not what it is called. Supplier's existing terminology can be used and incorporate into CSV.
For example:
- IQ may be called IT/CSP : installation and configuration
- OQ may be called SAT : business process and ranges, with standard system can leverage Supplier qualification docs
- PQ may be called UAT : intended use and acceptance
To begin digitalization in a laboratory with multiple types and brands of instruments and tools, follow these steps. First, identify pain points and define clear goals and objectives for digitalization, focusing on areas which have most added value (usually begin with the area which the most pain points). Then, Assess the existing infrastructure and understand the capabilities and connectivity options of the instruments. Next, Research vendors that offer digitalization solutions compatible with the instruments in the lab, if needed, ensuring they provide connectivity and data integration. Evaluate the needs of integration options and plan a phased approach, starting with a pilot project, provide training and support to personnel, and continuously monitor and evaluate the digitalization process for optimization.
Initial impact assessment is necessary to determine the need of CSV for the equipments. Several factors can be considered during the assessment:
- Impact of the equipment on the product quality, patient safety, and data integrity
- Automation and software integration, whether the equipment includes automation or software components that control or monitor its operation.
- Whether the equipment generate, process, record, or store data, and whether the data is used for regulatory compliance, quality control, or GxP decision-making processes.
If the answer to the above questions are YES then CSV is required. Important to note for most equipment, CSV activities can be aligned/included in equipment qualification activities (DQ/IQ/OQ/PQ) as long as the CSV concerns are covered.
The overall approach and framework is the same as in the initial edition. GAMP5 2nd Edition is updated with a focus on:
- Critical thinking, whether the validation scope and effort make sense considering the role and use of the system and help improve and contribute to quality
- The move from customised software projects to standard configurable products
- The importance of IT service providers, particularly the increased role of software suppliers and implementation with Cloud Service Providers
- Addresses and incorporates modern software industry practices:
- Agile development approach (not only waterfall)
- Software tools and automation used for development, deployment and control
- Updated case studies for todays IT systems
- Initial guidance on emerging technologies (AI, Blockchain)
- Latest initiatives (knowledge management, Pharma 4.0)
Conducting a CSV (Computer System Validation) process in the pharma industry can be challenging for several reasons:
- Expertise and Resources: CSV requires specialized knowledge and expertise in validation principles, regulatory requirements, some IT/computerized system technical knowledge and industry best practices. In pharma company these knowledge are usually spread out across various team (QA, Validation, IT, Engineering, etc) and makes it difficult to coordinate to perform CSV
- Changing of Regulation: Regulatory requirements for CSV are subject to change. Staying updated with evolving regulations and ensuring compliance can be a significant burden for users who are not dedicated to monitoring regulatory changes.
- Technical Complexity: Computer systems used in the pharmaceutical industry can be complex, encompassing various software applications, hardware, and interfaces. Validating such systems requires in-depth technical knowledge and an understanding of the interactions between different components. It can be challenging to comprehensively validate all aspects of a system, especially when it involves integration with multiple instruments or custom-built software.
- Experiences and risk based approach: Setting up a CSV programme as well as performing CSV are not a routine activities in pharma companies (apart from periodic review).
Given these challenges, some pharma companies may find it difficult to start and perform CSV activities. Pharma companies may choose to outsource CSV activities to specialized validation service providers or consultants who has the knowledge, experience, and resources to conduct CSV efficiently. We always recommend to do "train the trainer" approach in which the CSV consultant will train and provide some practical examples or perform CSV for some system while the inhouse team observed. This will ensure transfer of CSV knowledge and experience to inhouse team which can then perform the remaining CSV activities, maintain CSV operational compliance and provide explanation during inspection.
Factorytalk is a well-known CSV Consulting Company with specialized expertise in the field with more than 15 years of experience globally.
