Proper Procedure Execution Prevents Compliance Risk
BIOVIA white paper : Prodecude management Solution significantly reduces Compliance Risk Laboratories of regulated industries like BioPharma, Medical Device or Cosmetics need to focus on regulatory compliance in most aspects of their operations. With an increased number of Form 483s issued in 2019 the main observation citation was “Procedures applicable to […]
Achieve Merger & Acquisition through Data Integration
Merger & Acquisition: an increasing trend that requires Data Integration When a company decides to grow its market or its size, either an organic or external growth are envisioned. Over the last decade, Merger and Acquisition (M&A) in pharma industry has lived an incredible boom. The M&A process, from Acquisition […]
PLA2020 COMMUNICATION – Postponed to June 3 & 4, 2020
As mentioned earlier this week, we have been monitoring and evaluating the evolution of the COVID-19 situation and we also have received various communications that several companies, both sponsors and participants, do not allow their representatives to travel, especially in the region of North Italy. These restrictions have been already […]
PLA Communication about COVID-19 situation
Tuesday March 3rd, 2020 Considering the situation of the COVID-19 outbreak in Europe, major events cancelling or postponing across Europe and Airlines companies interrupting connections to Italy, many in our community are asking questions about this year’s Paperless Lab Academy . The PLA organization remains in close contact with the hotel, […]
How to solve legacy instruments Data Integrity gaps
Some instruments in the labs are not compliant to Data Integrity requirements At present, in the labs, there are still “legacy” measuring instruments, i.e. instruments that are there since ever and very often they’re not fully compliant to Data Integrity requirements. Usually, the remediation of their Data Integrity gaps is […]
GMP-compliant Data Management for Advanced Therapies
Advanced therapies are revolutionising the way we treat cancer Advanced therapies, or cell-, gene- and immunotherapies are revolutionizing the way we treat cancer.For example, have a look at Kymriah, a groundbreaking leukaemia treatment involving the genetic enhancement of the patient’s own immune cells. These novel treatments provide hope for many […]
Internet of Laboratory Things makes Life better at Work
Internet of Laboratory Things: What does #IoLT really means for you? Internet of Laboratory Things , #IoLT, is identified as a new step in the digitalisation of laboratories. But not only. A while ago, a Laboratory Director told me « if my instruments were connected and managed with error detection rules […]
Effective & Compliant Lab Informatics Implementation Projects
Benefit of a unique dedicated workshop about software vendor selection and risk management completing successful lab informatics implementation projects Transforming your laboratory and quality processes from paper-based to paperless ones require you to build on a very dedicated team for a lab informatics implementation and a very specific digitalization project. […]
How to provide relevant Search Results
The relevance of Search Results The relevance of search results is essential for finding information. Indeed, a user will almost never look further than the first few results of a search engine. It is therefore necessary that the relevant information is ranked as high as possible so that the information […]
Knowledge and Wisdom in R&D
Are you smart and wise enough for the future of R&D? In the previous contribution is Data the NewOil in R&D too? I discussed the bottom half of the “DIKW” pyramid : Data is the raw material at the bottom of the pyramid, possibly without context or use case Information […]
