European Pharmaceutical Review

MARCH 12, 2024

This can be achieved by implementing electronic systems with built-in controls to maintain data integrity, audit trails and access controls. Good documentation practices. Following good documentation practices (GDP) throughout all stages of data generation, collection, analysis and reporting is vital.

Documentation 89

Documentation Data Entry Communication Compounding 89

pharmaphorum

SEPTEMBER 11, 2020

Indeed, handling such data and finding resources to clean and manage it was overwhelmingly cited by Pharma Intelligence respondents as the most urgent challenge facing researchers over the next five years. Clearing redundant data then becomes difficult, and programming complex edit checks becomes impossible.

Data Entry 90

Data Entry Documentation 90

Pharmaceutical Technology

JUNE 15, 2023

AI also helps in interactions with patients, as it can be used for automating patient recruitment and data collection. AI-based analysis can provide insight into participant behavior that informs how researchers design trials. Many organizations also suffer from information silos between teams or departments.

Compounding 52

Compounding Adverse Reactions Dosage Documentation 52

ISPE

JUNE 21, 2023

The ISPE Sub-Committee for Paperless Validation has defined ‘Paperless Validation Systems’ as Paperless solutions enable validation lifecycle deliverables to be generated, approved, and more importantly, testing to be completed without the need for the printing of paper test documents. If It Is Not Documented, It Did Not Happen.

Documentation 52

Documentation Data Entry Compounding FDA 52

pharmaphorum

OCTOBER 6, 2020

To improve data confidence regulatory executives should take a four-step approach to change how they: Collect Data: Life sciences organisations should utilise cloud-based solutions with global access that facilitates one repository with a single source of truth and eliminates the use of local file sharing and servers.

Documentation 113

Documentation Communication Labelling Data Entry 113

pharmaphorum

OCTOBER 4, 2022

A key part of this initiative was the establishment of the Cancer Moonshot Biobank, which will ask cancer patients to donate biospecimens and associated health information to aid research. These datasets are critical as a means to identify how molecular information affects clinical outcomes.” Building a bank.

Documentation 105

Documentation Data Entry HIPAA Insurance 105

pharmaphorum

SEPTEMBER 6, 2021

Many practitioners have expressed the feeling that EHRs cause far too much of their time ultimately being spent on data entry. Additionally, issues such as poor quality documentation due to template-based reporting, and incompatibilities between different systems have further caused headaches and increased inefficiencies.

Medical Records 145

Medical Records Health and Personal Care Stores Data Entry Hospitals 145

ISPE

MAY 11, 2023

The key to data integrity compliance is a well-functioning data governance system 1 , 2 in which the data flow path for all business processes and equipment—such as in manufacturing, laboratory, and clinical studies—is fully understood and documented by a detailed process data flow map. Industry 4.0 Industry 4.0

Packaging 52

Packaging Documentation Communication Data Entry 52

pharmaphorum

DECEMBER 6, 2022

In most cases, the EHRs and EDCs don’t communicate, so in order to share that data with trial organisers, staff members at medical centres must manually copy data between the EHR and an EDC. Peleg expects that in the next five years, EHR to EDC linkage and data streaming will be the gold standard for clinical trials.

Data Entry 98

Data Entry Communication Hospitals Documentation 98