|
|
|
| home > white papers > PhlexEview: Transforming Costly Paper Processes into Value Driven Compliance - Phlexglobal Ltd |
|
|
 WHITE PAPERS |
|
Phlexglobal Ltd
|
|
PhlexEview: Transforming Costly Paper Processes into Value Driven Compliance
|
|
Phlexglobal, the TMF experts, have developed PhlexEview, its best of breed electronic Trial Master File (eTMF) system that supports efficient management and tracking of TMF content throughout the lifecycle of a clinical trial. PhlexEview transforms costly, stagnant, paper-based processes into dynamic, value driven compliance programs by capturing, tracking and managing global TMF activities and enabling unprecedented access to trial content throughout the conduct of the study.
Compliance is always the most critical factor when designing an approach to TMF management. But that doesn’t mean that an organisation has to spend time and money managing paper that does not support global access, collaboration or compliance efforts. PhlexEview supports compliance and collaboration by leveraging industry standards and making TMF content available to users, regardless of their location.
The ability to access and view TMF content at any time transforms sluggish and inert paper processes and helps organisations to realise time and cost savings by reducing travel costs, positioning team members to proactively identify compliance issues and implement corrective actions and by facilitating global collaboration. This paper discusses some of the challenges of traditional paper-based TMFs and provides details about PhlexEview. It also suggests a new approach to TMF compliance that extracts and sets the expectation for continuing value from TMF content, rather than locking it away in paper storage where its value is minimised.
|
|
|
|
|
|
|
|
 |
News and Press Releases |
 |
New assurance first for plastic pollution reduction
Businesses in the pharmaceutical sector can now take significant
verifiable steps to manage plastic waste and its impact on the
environment, thanks to the launch of the world’s first best-practice
standard for Responsible Plastic Management (RPM).
More info >> |
|
 |
White Papers |
 |
|
Cleaning Validation: What do you need to consider to ensure a successful outcome?
RSSL
Cross contamination must be avoided in the Pharmaceutical industry at all costs and successful cleaning validation ensures that patients are not put at risk due to cross contamination.
The process can be divided into a number of sections each of which must be fully understood and areas of concern addressed to ensure a successful outcome across the entire process. This spans both the manufacturing and subsequent analytical and microbological support.
The data used to confirm a positive/successful cleaning validation is underpinned by the results of validated analytical methods. It is essential that these results are truly representative as patient safety is based upon the absence of equipment residues.
So what are those areas of concern, what affects your ability to get a successful outcome and what do you need to consider when carrying out a Cleaning Validation exercise?
More info >> |
|
 |
Industry Events |
 |
World Vaccine Congress Europe
18-21 October 2020, Barcelona, Spain
The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
More info >> |
|
|
|
.jpg)
