Proper Procedure Execution Prevents Compliance Risk

biovia white paper

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 […]

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

inpharmatic 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

bigstock-White-Dna-Helix-In-Test-Tube

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 […]

Effective & Compliant Lab Informatics Implementation Projects

Academy training PLA2020

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. […]