Pharmaceutical Technology - October 2020

PharmTech - Regulatory Sourcebook - October

Issue link:

Contents of this Issue


Page 44 of 75

November 2020 S olutions promoting compli- ance focus on application soft- ware and IT/OT infrastruc- ture. Application software should support 21 CFR Part 11 through an HMI with electronic signature access; a tamper-proof audit trail recording alarms, events, invalid test runs and log-in attempts; and integration of single sign on, access permission, and role definitions across the entire automation infra- structure. Additionally, all applica- tion software should have version control for change management. Modern IT and OT infrastruc- ture should include a process histo- rian with data retention capability a nd prov ision for a n orchestra- tion layer to generate electronic reports. This ensures consistency and avoids human error often due to paper reporting. An automation system shou ld suppor t business continuity and prevent data loss through backup and restore pro- visions, end-point security, patch tracking and management, and the latest operating system. Once a basic system is in place, it w i l l b e i mp or t a nt to ma i n- tain data integrity for the next 20 years. Visua lization technolog y supporting streamlined operational workf low will improve quality and consistency throughout the life of your facility. Providing operations with a holistic view that allows for proper work planning provides in- sights into upcoming events and makes it easier to take appropriate ac- tions sooner to preserve the quality of each batch. Combining visualization with orchestration can provide com- pliance to legacy equipment. Advanced data analysis platforms that consolidate business-wide data provide real-time visibility and pre- dictive insights. This minimizes regulatory risk by providing a view of compliance across the enterprise and supporting paperless digital transformation. It also allows com- parison to a golden batch, and in- sights allowing improvements in quality and reduced waste. Finally, safet y and securit y in the life sciences industry is espe- cially critical; in addition to pro- tecting workers and facilities, it is important to be confident in the integrity and safety of your final product. Wit h recent repor ts of cybersecurity threats in life sciences companies, how can you improve OT cybersecurity in your facility to protect your data, process, and ultimately the patients that depend on your product? Whether you are looking to build an OT cybersecurity program at your facility or across multiple sites in your enterprise, you need to fol- low best practices to improve your cybersecurity posture. To learn more about embedding data integrit y into your produc- tion automation and control pro- cesses, v isit our Webinar Series page for on-demand webinars on audit readiness, improving cyber- security, batch visualization and workf lows, orchestration, and op- erational intelligence. ◆ Planning Audit-Ready Production Automation Amit Samel and Tiffany Barnes In today's environment of increasing regulatory concerns, it is becoming more important to plan automation of life sciences production around compliance and audit readiness. Embedding data integrity and quality support into automation from the start enables improved visibility and compliance across your operations. Amit Samel is a Technical Solutions Consultant with Honeywell's Life Sciences initiative. Amit has been working in the Life Science domain for the last 20 years and has led the design, commissioning and qualification of various Life Sciences Manufacturing facilities. Tiffany Barnes is a Technical Solutions Consultant on the Honeywell Life Sciences team, and has over 10 years of experience working on projects implementing controls, procedural operations and HMI across various industries. SPONSOR ED CON TEN T

Articles in this issue

Links on this page

Archives of this issue

view archives of Pharmaceutical Technology - October 2020 - PharmTech - Regulatory Sourcebook - October