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 |2022-03-18T10:36:32-04:0003/18/2022|

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 [...]

Advanced Planning: Developing Supply Risk Mitigation Strategies

By |2022-05-20T15:00:55-04:0002/09/2022|

Advanced Planning: Developing Supply Risk Mitigation Strategies Download the PDF Converge conducts a Manufacturing Supplier Risk Assessment and uses the results to build a Supplier Risk Management Plan. A commercial biopharmaceutical company was preparing for their second product launch when senior leadership acknowledged the need to prioritize the supply chain and manufacturing [...]

Benefits of Using Foreign Trade Zones for Emerging Biotech Companies

By |2021-12-07T11:14:42-05:0012/07/2021|

Benefits of Using Foreign Trade Zones for Emerging Biotech Companies We often see clients incurring high duties on importing key starting materials into the US. For emerging companies conducting R&D, paying duty on each import can significantly impact cashflow, sometimes measuring in the hundreds of thousands of dollars. This impact is amplified [...]

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 [...]

2022 Industry Serialization Requirements: Assessing 3PL Options for Sending EPCIS Data to Distributors

By |2021-11-16T08:50:29-05:0011/16/2021|

2022 Industry Serialization Requirements: Assessing 3PL Options for Sending EPCIS Data to Distributors Pharmaceutical manufacturers currently share transaction data with their trading partners at the lot level. The Drug Supply Chain Security Act (DSCSA) mandates package level traceability by November 2023. Cardinal Health and McKesson are requiring that manufacturers provide fully aggregated [...]

Manufacturers Need to Start Now to Prepare for 2022 Serialization Requirements

By |2021-11-08T17:08:01-05:0011/08/2021|

Manufacturers Need to Start Now to Prepare for 2022 Serialization Requirements While the Drug Supply Chain Security Act (DSCSA) does not require manufacturers to send package-level serialization data downstream until November 27, 2023, the Big 3 distributors are accelerating this timeline and requiring that data by November 2022. Cardinal Health and McKesson [...]

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 [...]

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