quality

Quality assurance

Vivotecnia has more than 10 years of experience in carrying out GLP studies. We are certified by Spanish national authorities to work under GLP and are regularly monitored as part of the compliance programs of the Ministry of Health for the Autonomous Community of Madrid and the Spanish national accreditation body (ENAC). We have satisfactorily undergone and passed 10 audits. All these inspections were carried out in accordance with the OECD guidelines for GLP audits and inspections. All studies carried out at our facilities are accepted by any competent authority worldwide.

Our certification includes the following areas:

  • Toxicology (since 2003), pharmacokinetics (since 2005), genotoxicity (since 2005)
  • Analytical tests and non-clinical sampling (from 2011): metabolism, pharmacokinetics, carcinogenicity

 

Our quality assurance unit is responsible for monitoring compliance with GLP and ISO standards. We work in a process-based environment committed to quality (ISO9001:2015).

Our compliance program is continuously evaluated by regulatory bodies, customers and consultants. More specifically, Vivotecnia was audited in 2012 by former Food and Drug Administration (FDA) inspectors on behalf of a U.S. multinational. As a result of this audit, we can state that Vivotecnia complies with CFR21 part 58 “Good Laboratory Practice for nonclinical laboratory studies” and part 11 “Electronic Records and Signatures”, in advance of future FDA inspections.

For correct and efficient laboratory IT management, Vivotecnia selected Instem’s ProvantisTM 8.5.2.1 software from among various laboratory information management systems (LIMS). For the last two years, we have been fine-tuning this system to verify that it accurately and reliably meets all current needs for its validation and eventual application to the technical processes we carry out.

In addition, Vivotecnia has designed an electronic system for standard operating procedures (SOPs) which allows on-line access to SOPs, thus optimizing their distribution and consultation, as well as permitting any suggestions for change or revision to be entered

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OVER 10 YEARS OF EXPERIENCE CONDUCTING GLP STUDIES

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