spacer
home > epc > autumn 2017 > top tips for clinical quality
PUBLICATIONS
European Pharmaceutical Contractor

Top Tips for Clinical Quality

Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) are fundamentally similar, in that the goal of each is to refine processes to ensure quality and facilitate conformance to regulatory guidelines. Both fall under the umbrella of good ‘execution’ practices (GxPs), which is intended to ensure consistency, data integrity, accountability, traceability and overall quality.

Understanding Operational Efficiencies

To see how GMP strategies can benefit the clinical world, it is necessary to thoroughly comprehend what a quality management system (QMS) is and what it is intended to do. A QMS is the collective set of policies, procedures, methods, resources, documentation and infrastructure required for the effective implementation of quality control and assurance in an organisation. The focus of these interrelated processes and activities is the achievement of quality objectives and policy that allow companies to execute measurable and repeatable procedures that meet regulatory requirements.

While some firms still rely on paper-based QMS operations, the use of a variety of hybrid paper-electronic systems or fully electronic QMSs is now more common. Historically, the QMS software solutions on the market have included modules for managing documents, training, quality events and reports/analytics. Automated QMS products currently on the market feature solutions specifically designed to manage other quality-related areas, such as audits and suppliers, under a single platform. While many enterprise QMS solutions are installed on premise, technological advances have spurred a trend of life sciences companies adopting cloud-based QMS solutions.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Patricia Santos-Serrao, RAC, is a life sciences professional with over two decades of experience in quality, regulatory and clinical business processes for the pharmaceutical and biotech industries. She worked for several Tier 1 companies, including Schering-Plough and Boehringer Ingelheim, prior to transitioning to various technology solutions and services providers for life sciences. Currently, Patricia is Director of Pharmaceutical and Biologics Solutions at MasterControl, developing solutions designed for the pharma industry with a focus on clinical operations, quality and regulatory affairs.
spacer
Patricia Santos-Serrao
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

GE Healthcare advances the delivery of cell therapies with new thawing technology


More info >>

White Papers

Data Technology as a Catalyst for Growth in the Life Sciences

AIGENPULSE

The life sciences industry is changing at a rapid pace. The need to develop the next blockbuster is pushing current technologies and methodologies to the limit. Scientific advancement over the last decades was embossed with giant leaps in knowledge, however, the new reality is that smaller incremental gains need to be carved out with ever increasing investments. In order to survive, progress and prosper in this new reality, a holistic approach to getting the most of research data is crucial. In fact, it will likely be the difference of being in existence in 5-10 years or not. For those bold enough to step into an area they are unfamiliar with, huge rewards are waiting.
More info >>

 
Industry Events

Pharmaceutical Microbiology East Coast

13-14 November 2017, Renaissance Woodbridge Hotel, New Jersey

Drawing on from the huge success of SMi’s Pharmaceutical Microbiology event series, SMi is delighted to announce the launch of Pharmaceutical Microbiology East Coast. Being the eighth in its series, this event will take place in New Jersey, USA, on November 13th and 14th 2017. Aimed at Microbiologists, Quality Control and Quality Assurance Managers, Pharmaceutical Microbiology East Coast 2017 will address the best practices for rapid microbial and sterility testing and tackle the challenges of contamination control.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement