Industry-wide initiatives, such as Continued Process Verification (CPV), Process Analytical Technology (PAT) and Quality by Design (QbD), are driving today’s pharmaceutical manufacturers to improve product and process quality and efficiency. From a high level, product and process understanding in manufacturing includes identifying and monitoring Critical Process Parameters (CPPs) and Key Performance Indicators (KPIs) for one site or across the extended manufacturing network comprised of geographically dispersed sites and contract manufacturing organizations. Analysis of process data helps improve understanding for better decision-making.
As the capabilities and functions inherent in Softwareas-a-Service (SaaS) solutions have matured and gained market acceptance, many vendors are offering SaaS versions of their software. SaaS solutions replace large upfront fees and costs with periodic payments at a fraction of the price, thus offering cost-effective alternatives to traditional packaged applications. This white paper explores best practices in SaaS selection and incorporation into laboratory practices that enable organizations to focus on their core competencies while utilizing best-of-breed software tools to achieve robust yet low-cost laboratory technology.
Conventional wisdom holds that biology is not just more complex to manage electronically, but actually more resistant than other areas of discovery to electronic systems such as electronic laboratory notebooks (ELNs). But Millennium, the Takeda Oncology Company, found that by clearly defining workflows and implementing a highly configurable notebook, it could begin moving its entire discovery organization—encompassing both chemists and biologists—to a single ELN system.
Improve data integrity and quality, ensure IP protection, increase efficiency, and collaboration and enable faster and better decision making.
Electronic Lab Notebooks are a key component of an electronic lab environment that helps scientists execute faster, more informed, high-quality science. It’s a vision scientists have talked about for decades.
The reality is that paper is more of a habit than a requirement. AstraZeneca discovered this when they aimed to introduce ELNs to improve the efficiency of their validated workflows for GMP API manufacture.
Change control is collaborative, iterative and labor-intensive. For any specific change event, multiple users are required to follow a prescribed set of tasks and processes, which need to be carried out in a defined sequence and are subject to multiple stages of review and approval. It’s very easy to lose track of where you are in the process, what actions need to be completed next, who owns them, and when they are due. Yet the consequences of such lapses can be very costly. This paper examines why it is absolutely vital for organizations to take a comprehensive, closed-loop approach to automating change management, spanning all areas of the organization and extending throughout the product lifecycle.
In 2008 Hollister did a thorough evaluation of available solutions to automate some key internal business processes including the tracking of product registrations and the management of CAPAs. Since Hollister has to track registrations for its products in many different countries, the Regulatory Affairs department needed an automated solution to track when a registration was coming due so they could submit a new packet to renew a registration. Additionally Hollister needed to upgrade its existing Corrective Actions and Preventative Actions (CAPA) management system that was built on a Lotus Notes platform that was going to be retired.
Ignyta, Inc., a biotechnology company focused on precision medicine in oncology, recently announced that it is exploring strategic options for taladegib and has entered into an amended and restated license, development and commercialization agreement with Eli Lilly and Company for the taladegib oncology program