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  1. How AstraZeneca Improved Validated Workflows In GMP API Manufacturing
    1/18/2017

    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 (active pharmaceutical ingredient) manufacture. Paper and its associated workflows were standard only because they were familiar and had been defined over time to meet the needs of scientists, process engineers and quality control and assurance staffs.

  2. Streamlining Change Control In Today’s Complex Life Sciences Organizations
    1/11/2017

    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.

  3. How Hollister Selected An Automated Solution For Tracking Product Registration And CAPA Management
    1/11/2017

    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.

  4. For Regulatory Retention Compliance In Life Science Industries And Clinical Trial Research
    1/11/2017

    “Digital born data” is found everywhere in regulated Good Practice environments for laboratory (GLP), clinical (GCP), and manufacturing (GMP) purposes, e.g., (GXP). Paper documents are also scanned into digital format (PDF) for storage and retention. This document explains the fallacy of thinking that system backup tapes suffice for electronic archive purposes. It then describes the characteristics of electronic archives and discusses the history and concepts supporting today’s practical experience with digital preservation for long term retention compliance in organizations subject to US FDA, EU EMEA, and other global authorities.

  5. True Scientific Knowledge Management In R&D: Electronic Laboratory Notebooks (ELNs)
    1/11/2017

    One tool holds a unique position among R&D informatics systems. Unlike other systems, electronic laboratory notebooks (ELNs) both produce data and consume information. An ELN’s ability to capture data, observations, experiences, and context is particularly powerful when combined with other data pipelining tools. The ability to link key pieces of data and mine experiments captured in the ELN for insights fuels true scientific knowledge management. This use case describes the broad organizational benefits that BIOVIA Workbook made possible for a global pharmaceutical company, highlighting how the system is supporting efforts to gain predictive control over key processes in Research and Development.

  6. 5 Reasons External Collaborations Fail In Drug Discovery
    1/11/2017

    In an effort to accelerate innovation, streamline the R&D process, satisfy healthcare expectations and improve the rate of return, pharmaceutical companies have come to embrace external collaborations and their outsourcing partners as an essential part of their discovery programs. This trend towards externalization is significant with roughly 90% of companies outsourcing some steps of drug discovery, and with half of all drugs now resulting from such partnerships. This white paper, discusses the different types of external collaborations research organizations engage in, the reasons that many of these partnerships fail to meet expectations, and an informatics solutions to overcome these issues.

  7. Biogen And Biovia: Answering Pharma Manufacturing’s Call
    1/11/2017

    Biogen’s Cambridge Manufacturing Facility leaders assessed their paper-based SOP delivery system. Their findings were that their procedures were inefficient and costly.

  8. Pharmaceutical Vial Capping Equipment
    12/16/2016

    Designed specifically for low to medium speed pharmaceutical, biotech and animal health capping applications.

  9. Pharmaceutical Vial Filling And Stoppering Equipment
    12/16/2016

    Designed specifically for low to medium speed pharmaceutical, biotech and animal health vial filling and rubber stopper inserting applications.

  10. PathGroup, CDC And The California Department Of Public Health Partner To Improve Cancer Care With Big Data
    11/29/2016

    PathGroup, one of the largest private providers of anatomic pathology and clinical lab services in the U.S., recently announced a new partnership with the Centers for Disease Control and Prevention (CDC) and the California Department of Public Health that standardizes nationwide state cancer registry data and reporting, enabling physicians, surgeons and researchers to make data-driven treatment decisions with real-time information and analyses