Newsletter | June 24, 2021

06.24.21 -- Transform Your Manufacturing Process Data Management

Best Practices: Improve Process Data Exchange In Sponsor/CMO Networks

In this webinar, industry leaders identify novel ways to collaborate and improve adherence to cGMP requirements and ensure compliant quality production. Learn how you can establish reasonable expectations for data visibility and sharing in sponsor/CMO relationships to ensure effective data management across the supply chain.

Suffering From Spreadsheet Fatigue? Transition To A Centralized, Compliant Data Management And Analytics Platform

The use of spreadsheets in life sciences manufacturing carries high tangible costs that may not be so obvious: manual data entry, competing data sets entered by different users, version control, security, and delayed data migration to Part 11 compliant systems. Learn how to avoid the time, cost, and risks of spreadsheets with a process information management system to improve data integrity, remain compliant, and make better, faster process decisions with confidence.

Drive A Successful CPV Program With Purpose-Built Software

An area of life sciences that has recently received significant attention around data, its integrity, and its management processes, is manufacturing. This article covers biopharma manufacturing process information management systems, with insights on how purpose-built systems incorporated into your continued process verification (CPV) program help meet FDA requirements and protect your business.

Key Factors For Successful Technology Transfer

Successful technology transfer is reliant on a few key variables, including robust process characterization and communication and collaboration among multiple teams and sites. The key determinant to achieving success is the exchange of accurate, compliant data in a relevant time frame.

Spotlight: How A Leader In CGT Transformed Batch Data Management And Approvals

A cell therapy developer has an extensive pipeline of CAR-T treatments with its lead program recently entering pivotal trials. It wanted to move away from Excel-based batch data management to a centralized database to accelerate process verification with workflows and a single version of the truth. Implementing Skyland PIMS® allowed them to tightly control batch data review and build a clear audit trail.

Insights From Industry Experts On Ensuring Process Data Integrity Through The Supply Chain

In this webinar, a panel of experts discuss how now, more than ever, the bio/pharma industry needs to adopt strategies to improve the gathering, analysis, reporting, and sharing of process data to establish indisputable integrity and improve decision-making.