Vivotecnia has over 10 years of experience in the performance of GLP studies. We have been certified by the health authorities to work under Good Laboratory Practices (GLP) and are routinely monitored as part of the compliance program of the Comunidad Autónoma de Madrid and of the Entidad Nacional de Acreditación (ENAC).
In total, ten GLP audits have been successfully passed by the Regulatory Authorities. All these inspections were performed in agreement with the OECD guidelines for national GLP inspections and audits. All studies performed at our test facilities are accepted by any competent authority worldwide.
The certification includes the areas of:
- Toxicology (2003 onwards), Pharmacokinetics (2005 onwards), Genotoxicity (2005 onwards)
- Dosing of test substance and non clinical specimen acquisition (2011 onwards): Metabolism, PK, Carcinogenicity
The Quality Assurance Unit is responsible for overseeing compliance with GLP and ISO standards and guidelines. We operate a strong process based environment focused on high quality delivery (ISO9001:2008).
Our compliance program is continuously evaluated by the regulatory authorities, clients and consultants. Furthermore, Vivotecnia was recently audited by former FDA inspectors on behalf of a US customer. They reported that Vivotecnia was fully complying with CFR21 Part 58 “Good Laboratory Practice for nonclinical laboratory studies” and Part 11 “Electronic Records and Signatures”, in anticipation of a future FDA inspection.
Vivotecnia selected ProvantisTM throughout different LIMS (Laboratory Information Management System) providers. The last two years, we have been demonstrating that the Provantis System accurately and reliably performs all the functions currently required by Vivotecnia, and is therefore validated and suitable for production use.
Vivotecnia has designed an electronic Standard Operating Procedure (SOP) system: permitting on-line access and control improving the manual distribution and consulting ratio as well as the introduction of suggestions for change or revision.
Over 10 years of experience in the performance of GLP studies