IT/Automation Articles - BioPharm International


IT/Automation Articles

A 25-Year Retrospective on Computer System Validation

December 1, 2012

This month, Sharon Strause, an industry consultant, provides a look back at "Computer System Validation Part I: Testing and Verification of Applications Software" by Leonard J. Goren.

Knowledge Management Implementation

April 1, 2012

The authors discuss the technology and guidance required to achieve good KM in a biopharmaceutical company.

Process Development: Maximizing Process Data from Development to Manufacturing

July 1, 2007

Process development and manufacturing for biopharmaceuticals are often disjointed activities. Disconnects among groups are aggravated by a lack of common terminology and poor data management practices. A UK biotech consortium has initiated a collaborative development effort to address data management issues. The proposed outcome is a data model, based on the ISA-88 Standard for Batch Control, to capture process and facility data throughout the product lifecycle. A data framework that follows the ISA-88 model can simplify process scale up and enable early views of project costs and facility fit.

ON-LINE PROCESS CONTROL: Automating the Control of Process-Scale Purification Columns Using On-Line Liquid Chromatography

February 2, 2007

This article discusses how on-line high-performance liquid chromatography (HPLC) can measure product purity in the column eluent stream in near–real time. These data can then enable the automation and control of a purification column operation, thus reducing product variability, shortening process cycle time, and increasing yield. An example application demonstrates how on-line HPLC is used as a process analytical technology to ensure the process can accommodate variability in the separation while ensuring the product meets its critical quality attributes.

Asset Management for Growing Biotech Companies

September 2, 2006

The challenge is to determine the optimal frequency for preventive maintenance and the optimal frequency and tolerances for calibration readings.

The Confusion Around COTS

September 1, 2006

Increasingly, pharmaceutical companies have recognized that software development is not their core competency.

Taking Control of Your Quality Control

July 1, 2006

Federal regulations are broad and open to interpretation. Most have not caught up with advancements in technology.

Operations Excellence: Perfecting IT Management SystemSelectionforBiopharmaceutical Organizations

June 1, 2006

The overhead expense that comes along with each new enterprise application adds up quickly, and can be somewhat invisible to owners of the system.

Filter Integrity Testing in the Pharmaceutical Process Environment

June 1, 2006

Air filtration also needs a filter integrity test method to guarantee the sterility of critical parameters.



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