article
Data integrity: an opportunity to improve classical microbiological methods
Data integrity (DI) continues to trend as a hot topic for pharmaceutical manufacturers, despite the fact it is an expectation that has been present for years.
List view / Grid view
Data integrity
article
Guide to Outsourcing
Welcome to European Pharmaceutical Review’s Guide to Outsourcing. In this edition, Eurofins Scientific, SGS Life Sciences, Charles River Laboratories, ACCI, Eurofins Amatsi Group and Thermo Fisher Scientific showcase their unique outsourcing services and discuss how they stand out from the competition.
article
Reality check: is robotic process automation a panacea for transforming regulatory affairs?
Regulatory operations are burdened by resource-draining document and data processing tasks, but is robotic process automation the definitive solution? If not, where does it have greatest application and appeal – and how can life sciences firms exploit the full benefits? Agnes Cwienczek scrutinises the technology’s potential.
webinar
Roadmap to compliance in environmental monitoring
5 October 2020 | By Merck KGaA
This on-demand webinar provides an overview of a holistic approach to achieve compliance with good manufacturing practice (GMP) requirements for environmental monitoring (EM) in aseptic manufacturing areas, such as ISO 5 cleanrooms in traditional setup, RABS or isolators.
article
How digitalisation can help pharma weather the COVID-19 storm
Andrew Dunbar outlines five digital technologies that can help pharma function to the best of its abilities over the course of the COVID-19 pandemic.
article
Exploring and deploying blockchain solutions in the life sciences and healthcare sectors
Blockchain is perhaps best known as the technology on which Bitcoin and other cryptocurrencies are built. Notwithstanding that adoption in the life sciences and healthcare sectors is still in its relative infancy, companies and other organisations in these sectors are increasingly exploring and deploying blockchain solutions. Here, legal experts James…
article
Improving quality in investigator‑led clinical trials
Laura Trotta explains why risk-based quality management is the best strategy to ensure data integrity of information from investigator-led clinical trials.
product
Product hub: New MET ONE 3400+ air particle counter
Beckman Coulter Life Sciences has introduced the MET ONE 3400+ portable air particle counter to help GMP cleanroom users simplify their routine environmental monitoring and improve data integrity.
webinar
Delivering value: how LIMS can enable data integrity in pharma manufacturing
4 August 2020 | By Thermo Fisher Scientific
Find out more about industry issues, solutions, trends and how LIMS can enable laboratories to accelerate science and drive productivity, while ensuring regulatory compliance in our on-demand webinar.
whitepaper
Brochure: GMP Manufacturing
Quality control testing instrumentation solutions for GMP manufacturing. From raw materials QC through production QC and final product QC.
whitepaper
Whitepaper: GMP Cleanrooms Classification
This whitepaper from Beckman Coulter discusses GMP Cleanrooms Classification and Routine Environmental Monitoring.
whitepaper
Whitepaper: GMP Cleanroom Environmental Monitoring
This whitepaper from Beckman Coulter explores GMP cleanroom routine environmental monitoring and data integrity.
whitepaper
Infographic: Maintaining data integrity
Maintaining Data Integrity. Did you know that lack of data integrity has been a top reason for FDA Drug GMP warning letters?
whitepaper
Brochure: MET ONE 3400+ Air Particle Counter
The new MET ONE 3400+ Series PortableAirborne Particle Counter automates environmental monitoring for GMP cleanroom compliance.
whitepaper
Whitepaper: Enabling data integrity during drug manufacturing
High data quality and integrity is critical to ensure successful manufacturing of a drug. This whitepaper discusses how utilisation of software systems such as SampleManager LIMS enables and promotes compliance with regulations for the manufacturing of a drug.
