Pharma IT Articles

At its August meeting, the BioPharma Operations Excellence Consortium focused o­n automation and IT solutions.

For full article Click Here

This installment of the o­ngoing series discusses performance qualification of software in regard to system requirements.



For full article click here

Generic LIMS rely o­n too much customization to meet the needs of today’s pharmaceutical research environment. Too often, companies believe they have to purchase a laboratory information management system (LIMS) from a selection of generic systems and then spend many years and significant additional money to install the system, customize it to address critical functions that are unique to their industry, and then validate the system.

For full article Click Here

The biotech industry, more than most others, depends o­n its IT systems’ stored data for survival. The vital research and test results stored in such systems must be 100% protected. At best, lost or corrupted data can be expensive — costing time, labor, income, and customers. At worst, damaged or lost data may be irreplaceable, threatening business survival. Biotech companies cannot afford to lose data that may have taken years to collect.

For full article Click Here

During the past several years,many pharmaceutical companies identified a need for an electronic tracking system that would help them meet FDA GxP requirements.Most of the companies beganto seek a configurable product that could be quickly and easily implemented.The authorsdescribe a quality-management system that draws o­n a Good Automated ManufacturingPractice Special Interest Group document to help users implement Part 11requirements.

For full article Click Here

An installment of the Focus o­n Quality column.


For full article click here

What issues does 21 CFR Part 11 present to the pharmaceutical industry? How will technologies such as enterprise content management, level-4 instrument control and open system technology assist in automating multi-vendor instrument data capture, long-term data archival and record retention processes?


For full article Click Here

Guest editor Mark Fish examines how the emerging technology of web services is structured, and details the potential benefits it offers to research and drug discovery laboratories.

For full article Click Here

FDA enforcement of a 1997 CGMP regulation 21 CFR Part 11 for electronic records andsignatures is imminent and anticipated to be extensive.The popular use of open architectures and commercial off-the-shelf software products for automated batch control and data management hasintroduced many challenges to compliance with this regulation. In addition, legacy systems are not exempt, and verification of data integrity compliance is expected to be retroactive.Batch SCADA systems have the proven ability to reduce costs and improve product consistency, and the industry is heavily dependent upon their continued application in the manufacturing environment. In this article, regulatory requirements are reviewed with real-world examples of assessment and compliance resolution for Batch SCADA systems. System functionality requirements are stressedwithout direct reference to product or service brand names.

FDA expands electronic data submission programs to improve regulatory operations and ensure appropriate and safe drug use.



For full article Click Here