How Exquando and APROPLAN Enabled a Global Pharmaceutical Company to Be Always Prepared for FDA Site Inspections
This pharmaceutical company is a global leader in the healthcare industry. In Belgium, it houses the company’s Vaccines in Rixensart, Gembloux and Wavre. These company’s sites are worldwide centres for research, development and manufacturing of the company’s Vaccines. The Wavre site is a relatively new multiproduct facility and specifically designed to manufacture human Papillomavirus vaccine, hepatitis A and B adult vaccines, diphtheria-tetanus-pertussis vaccines, and flu vaccines. Because of the products it mainly manufactures, the company’s Wavre has to undergo and pass initial and periodic inspections of systems that are used to manufacture and provide quality controls in order to keep operating. Facility and equipment validation, process validation, aseptic process validation, environmental monitoring, quality systems, QC laboratory controls, production process, etc. were all documented semi-manually. The company’s Wavre needed an efficient and effective way to deal with their documentation procedures.
Following successful collaborations in providing document management solutions for the company’s construction projects in 2014, Exquando, the document and content management specialist company, became an official APROPLAN partner-distributor. After this success, it decided to move forward with Exquando to apply new processes in analysing and documenting specific pharmaceutical processes internally — a completely different direction with how APROPLAN has always been used. This specific (and fresh) way of using APROPLAN in an Exquando-designed process —hereby referred to as “FDA-Inspection Readiness” Process— has been saving time and money for the pharmaceutical company since mid-2016.
Exquando has now successfully implemented and integrated APROPLAN (replacing the traditional pen-and-paper process) to check the company’s procedures and documents in order to comply with strict compliance with the FDA (Food and Drug Administration, CBER (Center for Biologics Evaluation and Research), and other pharmaceutical authorities. Process implementation has been simple and straightforward due to APROPLAN’s robust application and trouble-free integration with other systems such as SAP, Navision and Salesforce. On the other end, Exquando has been enjoying APROPLAN’s digital end-to-end process, its dashboards that allow for transparent and immediate feedback, and the quality of support from the APROPLAN team.
Marc Ansoult - Managing Director
“To best advice our clients in the area of document management systems, Exquando is continuously keeping itself up-to-date on any developments for such platforms. We find Aproplan particularly interesting thanks to its ease of use, its quick and simple set-up, and its almost immediate return on investment.”
Clearly, APROPLAN’s mobile collaborative platform is not only limited to the construction sector but is applicable and extends to other fields that involve document management. Exquando has evidently demonstrated this with how they can configure APROPLAN according to specific project requirements.
APROPLAN is a mobile application available on the web, on the iPhone and the iPad. The platform is available from €29 per user per month. You can also track small projects for free. Contact APROPLAN today to start discussing how we can help you help your customers.
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