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DRAXIS PHARMA PARTNERS WITH INVENSYS TO ENSURE COMPLIANCE
Draxis turned to Invensys Validation Technologies, Inc., for compliant consulting and services. Having worked with Invensys on a previous ERP project and other validation projects, Draxis Pharma believed that Invensys had the experience and expertise to get the job done.” We talked to several other vendors and felt that Invensys had the strongest skills and experience available,” says Gilbert. “We had a very good relationship with the Invensys team, which brought to the table clearly qualified and competent leadership.
Working together, we were able to establish a simple process and a clear methodology. One of the most important things for Draxis was having excellent open lines of communication, a clear delineation of roles, and an agreed-upon set of work requirements that needed to get done.”
In the end, the entire project — which required meeting aggressive deadlines — was finished on time and within budget. Since its completion, Draxis has successfully passed several client and regulatory audits (FDA, MCA, HPFBI). According to Gilbert, the project has helped Draxis Pharma establish a competitive edge. “This work has helped us create a strong selling point for our company,” he explains. “When we can demonstrate to our customers that our computerized systems are compliant, it gives those companies a certain comfort level about how we conduct business. In addition, since we have plans and methodologies in place, we can now design and implement new systems in less time and know that they will meet the appropriate levels of compliance. Ultimately, we now have a very controlled IT infrastructure, which is so important to companies in our industry.”