spacer
home > > autumn 2017 > top tips for clinical quality
PUBLICATIONS


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.

 You must be a member of the site to make a comment.
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

Altasciences Acquires Sinclair Research and Continues to Expand Preclinical Platform

Laval, Quebec, January 4, 2022 – Altasciences, an integrated CRO/CDMO offering pharmaceutical and biotechnology companies a seamless solution to early-stage drug development from lead candidate selection to clinical proof of concept, announced today the completed acquisition of Sinclair Research, a preclinical CRO located in the Midwest. Complementing existing locations on the East and West Coast, the new site will facilitate even greater access to Altasciences’ preclinical services across the US.
More info >>

White Papers

Pharmaceuticals and Healthcare Products

Turkish Cargo

Pharmaceuticals are requiring safe and reliable transportation for being highly temperature sensitive products. Thosepharmaceuticals are; diagnostics, vaccines drugs, sera, plasma, protein clinical trials, biotechnological material, pills and all kind of medicines. Turkish Cargo transports all kind of pharmaceuticals, and has been carrying out its operations of transporting and storing drugs and temperature-sensitive medical supplies successfully and with the experience of 80 years; since 1936.
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement