|
|
|
| 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 |
 |
3P Biopharmaceuticals receives FDA approval
[Pamplona, September 16th, 2019] 3P Biopharmaceuticals (3P), a leading Contract Development and Manufacturing Organisation (CDMO) specialized in process development and GMP manufacturing of biologics, receives FDA approval after completing the Pre-Approval Inspection (PAI) conducted at the 3P drug substance manufacturing facility.
More info >> |
|
 |
White Papers |
 |
|
Detecting Integrity Breaches in a range of Pharmaceutical Blister Package Types using Sepha VisionScan
Sepha Limited
Demonstrating the integrity of pharmaceutical blister packs is critically important, as any defects can affect the shelf life and efficacy of the contents. Compared to bulk packaging, blister packs offer improved product integrity, tamper evidence and reduce the likelihood of misuse. Packs can be composed of either a thermoformed polymer or cold formed aluminium tray, with a number of individual pockets to hold the product. After the tablets or capsules are placed in the pockets, the packs are heat sealed with a paper or foil laminate sheet. These various stages can be completed separately or integrated into a single form, fill and seal process. There is a risk of microbial containment or degradation of the contents if any defects are present in the packaging. Such defects can take the form of rips or pinholes in the tray, or lid materials, faulty seals and channel leaks between pockets.
More info >> |
|
 |
Industry Events |
 |
12th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology
8-11 February 2021, Vienna, Austria
In continuation of the very successful scientific meetings in Budapest, Paris, Berlin, Florence, Geneva, Barcelona, Malta, Istanbul, Lisbon, Glasgow and Granada, the 12th PBP World will be held in Vienna from 8-11 Feb 2021. This every two year held conference has gained an ever increasing impact among the pharmaceutical scientists: With up to 1000 submitted abstracts and about 1300 participants it has become a well-established major meeting, attracting scientists from all over the world.
More info >> |
|
|
|
