whitepaper
Whitepaper: Optimising the efficiency of QC laboratory: The power of automation
Charles River launches Endosafe Nexus 200, emphasises the importance of automated endotoxin testing systems to improve the efficiency of QC labs.
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Data integrity
article
GAMP 5 update: computerized system expectations for pharma manufacturers
The International Society of Pharmaceutical Engineering’s GAMP® 5 guidelines steer validation practices for pharma companies to meet computerized system expectations. Members of the GAMP steering committees, Lorrie Schuessler, Charlie Wakeham and Stephen Ferrell, share the some of the key changes in the second edition update and how these should be…
whitepaper
Whitepaper: LIMS integration: overcoming the hurdle of microbial QC digitalization
Learn how automated microbial enumeration technologies can ensure seamless integration of LIMS, improving lab efficiency and data integrity.
whitepaper
Case study: Reduce plate counting costs and delays
Learn how a US influenza vaccine manufacturer concerned with intermittent positive plate counts used rapid microbial monitoring to save time and money.
article
An Annex 1 and Pharma 4.0 perspective on water quality
Pharma 4.0 is coming and is further driven by the recent update of the EU GMP Annex 1 regarding manufacturing of sterile medical products, setting new regulatory expectations in all manufacturing processes. Here, Isabella Jul-Jørgensen from the University of Denmark focuses on sterile water quality and how the new requirements…
news
NICE partners with health technology assessment bodies
Five health technology assessment (HTA) bodies will collaborate with NICE to help resolve regulatory and digital health technology challenges.
video
On-demand webinar: Effective contamination control strategy
Discover the significance of accurate microbial identifications in building an effective contamination control strategy to keep up with the latest regulatory requirements.
whitepaper
Guide: Rapid microbial detection methods
Plate counting falls short in reducing the risk of contamination during pharmaceutical production. Learn more about rapid microbiological methods.
webinar
Validation and implementation of a novel automated PCR technology for mycoplasma testing
22 September 2022 | By bioMérieux
This on-demand webinar presents the regulatory submission strategy for implementation and validation of a new PCR-based technology for mycoplasma testing of different products.
whitepaper
Whitepaper: Building a tomorrow-ready lab with CaliberLIMS
Achieve digital lab transformation by becoming future ready with the 100% paperless lab requisites. Check the wish list for a better tomorrow lab.
whitepaper
Whitepaper: Annual PQR: A thing of the past
Anytime PQR is the new way of generating APQR by automating the reports anytime in 3 easy steps. Now make the entire process system driven with CaliberAPQR.
podcasts
EPR Podcast Episode 13 – QC spectroscopy compliance – Garry Wright and Julia Griffen, Agilent
Discover the common compliance concerns encountered when using spectroscopy instruments for QC, as well as how to rectify them in this episode with Agilent Technologies.
video
On-demand webinar: The advantages of cartridge technology
Why do pharmaceutical manufacturers still believe older methods are reliable for quality testing when there’s superior technology available on the market?
whitepaper
ebook: Guidance on implementation of ARMMs
Many quality control professionals recognise that the need to modernise microbial detection methods is at an all-time high.
article
Five areas in life sciences where data integrity is vital
Anca Ciobanu, Strategic Theme Lead at the Pistoia Alliance, discusses the need to ensure data integrity in life sciences. She explains how data integrity can reduce costs and increase patient safety across five key areas: reproducibility, IDMP, the microbiome, semantic enrichment, artificial intelligence and machine learning.
