Document Migration

WHITE PAPERS AND CASE STUDIES

• The Regulatory Evolution And Data Revolution In Medical Device Development

  The Life Sciences and Healthcare industries are among the most heavily regulated industries in the world. This paper looks at the current, dynamic regulatory landscape within the medical devices sector and some of the current and future changes medical device organizations will need to adhere to. The in-vitro diagnostics (IVD) sector is also going through regulatory change - a topic that is out of scope for this paper.

• Power Loading Reduction

  In the power utility industry, independent system operators (ISOs) are quasi-governmental organizations that serve as neutral market-makers between power generation companies and consumers to help ensure the power grid performs at maximum efficiency and reliability. While they don’t own generation, transmission, or distribution assets, nine ISOs play an important role to balance the supply and demand for power in North America.

• Clinical Supply Optimization: Process Improvement Accelerates Clinical Trial Deliverables And Execution

  A biopharmaceutical sponsor required the study startup phase to be reduced to 91 days, involving comparator sourcing and blinding, kitting, packaging, labelling and distribution to the sites.

• Leader In Restorative Cell Therapies Embeds Skyland PIMS® As Process Knowledge Base From Clinical To Commercial Manufacturing

  A leader in the development of restorative cell therapies has a pipeline of products that may offer rapid-onset pain relief and restored function for orthopedic use. By implementing Skyland PIMS into their manufacturing plan, the drug developer is able to securely manage critical data in a collaborative, cloud-based, 21 CFR Part 11 compliant workspace.

• From Liability To Asset: A TMF Rescue

  The company had acquired a promising compound with data from 14 clinical trials, including a critical phase III study. During NDA preparations, they discovered that the Trial Master File for these studies was scattered across hundreds of boxes of paper and several hard drives. The document experts at Phlexglobal quickly scoped the project and were convinced they could deliver an inspection-ready TMF in the time allowed – which was fast running out.

• Pharmaceutical Company Quickly Transitions 28 SKUs To Comply With New Labeling Requirements

  A large multi-national pharmaceutical company needed assistance in complying with new Health Canada regulatory requirements for labeling over-the-counter (OTC) products. The project scope required bringing 28 SKUs that varied by dosage form, quantity, primary and secondary packaging, as well as therapeutic area – and each SKU had its own unique packaging demands and timeline to maintain an unaffected retail shelf presence - into compliance with PLL. Read how all 28 SKUs were delivered in accordance with the forecast timelines and the overall project was completed early.

• Automating Backup: Opportunities & Best Practices

  You already know that backing up your organization’s data isn’t a nice-to-have, it’s a need-to-have. The external threats alone warrant this. You could be one of the 50% of all organizations operating a data center that can’t withstand, or is unable to operate after, a natural disaster. Or, you could be one of the 39% of global organizations that experienced a ransomware attack in recent months.

• Drone Standards And Best Practices

  Learn intelligence business practices and guidelines for implementing drone operations or hiring professional service providers in the U.S.

• Gas Utility Reduces Inspection Times By 50% Using Mobile App

  Challenged to meet regulatory requirements, a natural gas distribution utility was able to replace slow and unreliable paper data collection processes with a mobile data collection app. The new digital workflow included data capture via bar code saved significant time in getting accurate data into the utility’s digital network as-builting process.

• The Integrated Pharmaceutical Development Platform: Transform The Commercialization Of Innovative Therapeutics

  This whitepaper introduces the concept of the electronic Development Record (eDR) and how a holistic, platform approach to the capture, management and re-use of product and process data can propel the development process forwards, reduce costs, improve quality and enhance corporate image.

• Faster R&D Of Pharma Production Lines

  This use case demonstrates a solution that empowers users by connecting to all relevant data sources to visually represent batches and perform analytics with process data.

• Understanding CDMO Selections: A Case Study Of Getting It Right

  Identifying key decision-makers and exploring how they reach determinations allows CDMOs to reshape imprecise product based marketing into messaging that addresses specific customer concerns.