Jun 9, 2021 - (SPARTA NJ) - A computer system operating in a company regulated by the U.S. Food and Drug Administration (FDA) does not solely consist of computer hardware and software. It may also include any equipment and instruments connected to the system, as well as the users who operate the system or equipment following standard operating procedures (SOPs) and manuals.
April 19, 2021 - (SPARTA, NJ) - Gap Assessments are a standard in the Life Sciences Industry and are utilized by all size companies as a quality control and compliance mechanism. The results of the assessment and the recommendations it produces ensure that the Quality System program works in accordance with established rules and regulating body standards.
January 27, 2021 - (SPARTA, NJ) - One of the biggest mistakes companies make when starting a computer system validation (CSV) project is to not do the strategic planning necessary to ensure success. That is according to Ray Roggero, Managing Member and Operations Leader for Medvacon Life Sciences.
December 23, 2020 - (SPARTA, NJ) - When electronic records need to be validated, you can turn to Medvacon Life Sciences—a Quality, Compliance and Validation consulting company. And when it comes to Laboratory Information Management Systems (LIMS) in the biotech, pharmaceutical or medical device industries, Medvacon offers validation support in every phase of development from pre-clinical to manufacturing.
December 4, 2020 - (SPARTA, NJ) - Medvacon Life Sciences—a Quality, Compliance and Validation consulting company—is working with compounding pharmacies to help identify gaps in quality systems to ensure that they meet current FDA requirements to supply safe and effective products. Additionally, as part of supporting the rapid start-up of a new facility, Medvacon will be supporting the ongoing day-to-day quality operations, helping to facilitate the rapid growth of the compounding pharmacy in a fully compliant manner.
November 20, 2020 - (Sparta, NJ) - Medvacon Life Sciences—a Quality, Compliance and Validation consulting company—is contributing to the mRNA production of vaccines to prevent the COVID-19 virus by ensuring that the cutting-edge technology meets the stringent expectations of the FDA. Medvacon is supporting companies in the areas of process validation, verification, cleaning validation, facility and utility qualification as well as process development.
September 13, 2020 - (SPARTA, NJ) - Medvacon has expanded into four unique organizations: Medvacon, LLC is a holding and management company; Medvacon Life Sciences, LLC, which provides Quality, Compliance and Validation consulting services to the Pharmaceutical, Biotech and Medical Device industries across the country and throughout the world; Medvacon Talent Acquisition, LLC, a full-service recruitment firm; and Medvacon Compliance & Training, LLC, which is focused on providing training and development programs to companies regarding quality and quality systems.