spacer
home > pmps > autumn 2017 > redefining processes
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Redefining Processes

Over the past few years, track and trace and serialisation have gradually become buzz words in the pharmaceutical industry due to approaching regulatory deadlines such as the EU Falsified Medicines Directive. Despite the growing awareness, serialisation is still a relatively recent concept, creating new challenges and operational changes that can differ from company to company. As a result, the entire industry is grappling with a steep learning curve on how best to deploy new systems, software and processes for serialisation in a continuously evolving environment.

One of these critical processes is software validation, which ensures serialisation software meets specifications and fulfils its intended purpose. Traditionally, a company will dictate when they want to validate their software depending on scheduled upgrades. However, the conventional approach to validation is simply unsustainable at the rate of change that is being seen across the industry.

Companies vary considerably in how many trade partners they have, as well as how many global regulations they are required to comply with. The subsequent need for Compliance-as-a-Service (CaaS) is dictating a new model, Validation-as-a-Service (VaaS), through automated validation to keep serialisation solutions constantly validated while adapting to ongoing industry and internal changes.

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
Dan Walles is Vice President of Global Solutions at TraceLink where he brings to his role more than 20 years of experience in product management, solution consulting and service delivery. He has focused exclusively on the needs of the life sciences industry for the past 15 years. Since joining TraceLink in 2010, Dan has been instrumental in educating customers on the company’s life sciences cloud and partner ecosystem to enable compliance and added business value through supply chain visibility and improved patient outcomes. 

Lisa Reinhold is Vice President of Global Customer and Network Success at TraceLink. Throughout her career, she has demonstrated success in building exceptional global customer service and support organisations in highly competitive and emerging markets. At TraceLink, Lisa is responsible for understanding and advocating for the needs of customers to ensure both long-term customer success and on-going growth of the company’s network. In her role, she is passionate about fine-tuning solutions to customer expectations and building her team of skilled service professionals. 
spacer
Dan Walles
spacer
spacer
spacer
Lisa Reinhold
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

ICON Announces Executive Leadership Transition


More info >>

White Papers

How To Increase Efficiency, Customer Satisfaction and Reduce Cost

AC Labels

A customer of Riverside Medical had required a complex four-part 'piggy back' label. The labels needed to be specially constructed to facilitate removal in parts at various stages of its use for quality control traceability. This label needed to carry variable data elements of LOT numbers, batch numbers and product descriptions, and also a secondary gamma indicator label placed on each of its 4 sections to prove its sterility following sterilisation.
More info >>

 
Industry Events

3D Cell Culture 2018

21-22 February 2018, Holiday Inn Kensington Forum, London UK

Building on the sell-out success of the launch event, SMi Group is delighted to announce the return of 3D Cell Culture, taking place on 21st and 22nd of February 2018, in London UK.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement