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BioVoke Supports a Risk-Based Approach per ASTM E2500

By Scott Hamm, August 10, 2016

How does the BioVoke Product and Process Knowledge module support the specification, design and verification process using a science and risk-based approach per ASTM E2500?

BioVoke™ Product and Process Knowledge module helps you “listen to the voice of the product” – what does the product need from the process, the equipment, the facility – in order to be produced in a high quality, high yield, high reliability way with a low cost of goods manufactured?  With or without a defined product, all processes must have a process control strategy built into the specification and design:  one that minimizes costs, minimizes risks to quality, minimizes risks to project delivery, minimizes risks to manufacturing, and maximizes production reliability and robustness.

 

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How BioVoke can improve your bottom line?

By Scott Hamm, May 17, 2016

BioVoke is a next generation enterprise software solution designed to improve how you manage GMP information and project delivery in a paperless environment.  It was developed by seasoned CAI professionals that have a depth of knowledge and experience in this area.  BioVoke is a cloud-based product that supports a science and risk-based approach by managing project and life cycle activities based on QRM principles.  Our Product and Process Knowledge application, which allows for product and process definition, risk assessments and control strategy development, provides a scientific foundation for subsequent requirements definition, design review, planning and testing.  In addition, it includes necessary and efficient solutions for document management, discrepancy management and change management.

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20 Years of Meeting a Higher Standard

By Tim Howard, April 19, 2016

Commissioning Agents, Inc. (CAI) was founded with a mission to become the world wide leader of value-added commissioning services for Biopharm facilities and to be an agent for change in the industry.  On the occasion of our 20-year anniversary, we celebrate our past and provide a vision for the next 20 years.

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Help The OEM Help You. Better Designs From Suppliers With In Depth RFI

By Marie Getsug, April 15, 2016

Identifying Original Equipment Manufacturers (OEMs) with the capabilities and experience to design, build and deliver physical assets that perform beyond stakeholders’ expectations is an important initial step in delivering a successful project. Yet when tunnel vision sets in at this early phase of concept and design and firms begin focusing in on the traditional metrics of initial costs, scope and schedule to define a project, the opportunity to raise the bar on obtaining the lowest possible life cycle costs (LCC) through improved long-term performance is often lost before it’s even defined.

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Serialization: Are You Ready For Changing Regulations?

By John Hannon, April 12, 2016

If the pharmaceutical distribution network is at risk, so is patient safety. With counterfeit drugs on the rise, serialization programs are being implemented to safeguard the integrity of product reaching the market. Serialization also provides better controls to communicate recall information should it become necessary.

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Do You Have Rouging Problems?

By Nissan Cohen, April 10, 2016

Recently rouging of two process vessels at a blood fractionation facility shut down production. 

The tanks of concern were derouged and passivated just 10 days before the rouge was observed on product contact surfaces prompting great concern.

The tanks are configured with baffles and stirrers connected to a main shaft.  “Staining” was noticed by the operators on several of these product contact surfaces.

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How to Understand ASTM E2500