Event Recap: 2022 & Beyond – Serialization Requirements for Manufacturers

By |2022-11-14T11:53:27-05:0010/25/2022|

Event Recap: 2022 & Beyond - Serialization Requirements for Manufacturers To ensure product safety, the Drug Supply Chain Security Act (DSCSA) requires pharmaceutical trading partners to share data that tracks product movement and traceability through the supply chain. The sharing of data is dependent on the Electronic Product Code Information System (EPCIS). Although [...]

Info Sheet: Extending Your Quality Capabilities

By |2022-08-18T13:38:34-04:0008/18/2022|

PDF Available > Focusing on patients and improved outcomes in a rapidly evolving environment requires maintaining appropriate controls to ensure quality and compliance from early in the lifecycle. A well-designed and stage-appropriate Quality Management System (QMS) is essential to facilitate the development and commercialization of these advanced treatments. Converge Consulting understands the complexities and [...]

Transitioning to Computer Software Assurance from Computer Systems Validation

By |2022-03-29T09:57:35-04:0003/29/2022|

Transitioning to Computer Software Assurance from Computer Systems Validation Life science companies need to verify that GxP computer and software systems accurately support their intended business processes. The traditional approach for meeting this requirement is computer system validation (CSV). CSV emerged decades ago when computer systems were less reliable, and software was [...]

Event Recap: Building High-Touch Patient Supply Chains

By |2022-11-14T11:51:17-05:0003/18/2022|

Event Recap: Building High-Touch Patient Supply Chains Patient Outcomes: A Shift in Industry Focus The healthcare industry is increasing use of patient outcomes as a measure of quality and value. This drives biopharmaceutical companies to focus on patients in their commercial operations, technical operations, and supply chain. It was first prioritized [...]

2022 & Beyond: Serialization Requirements for Manufacturers

By |2023-01-03T15:22:15-05:0012/13/2021|

Life Sciences Supply Chain Working Group Webinar January 20, 2022 @ 12-1p ET 2022 & Beyond: Serialization Requirements for Manufacturers Read the Event Recap The Drug Supply Chain Security Act (DSCSA) requires pharmaceutical trading partners to share data that tracks products and provides traceability through the supply chain. The sharing [...]

Pushing “Fast Forward” on Serialization Requirements: What Manufacturers Need to Do for 2022

By |2021-12-07T12:19:34-05:0011/16/2021|

Pushing “Fast Forward” on Serialization Requirements: What Manufacturers Need to Do for 2022 Originally published as a MassBio Guest Blog Stephanie L Byrne is a senior supply chain consultant and serialization lead focusing on DSCSA project leadership. She has helped more than a dozen life sciences companies realize the greatest impact from [...]

Personal Information Protection: Broader than You Think

By |2021-11-02T10:12:07-04:0011/02/2021|

National and state governments are enacting laws to protect personal identifiable information (PII) from use without data subjects’ consent. Additionally, federal regulations are now in place to safeguard protected health information (PHI). A few examples of such laws active today are the General Data Protection Regulation by the European Union, the California Consumer Privacy [...]

Building Supply Chain Resilience: The Biden Administration’s 100-Day Supply Chain Review Findings on Pharmaceuticals and APIs

By |2022-05-10T10:55:54-04:0006/24/2021|

Building Supply Chain Resilience The Biden Administration’s 100-Day Supply Chain Review Findings on Pharmaceuticals and APIs On February 24, 2021, President Biden signed an Executive Order on America’s Supply Chains (EO) as a step toward building more secure, robust and resilient supply chains. The EO initiated a 100-Day Supply Chain Review, which detailed an assessment of the strengths and [...]

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