QAtive - supportive in quality assurance

Process optimization is the discipline of adjusting your process in such a way as to optimize some specified set of parameters without violating some constraint. The most common goals are minimizing cost, maximizing throughput, and/or efficiency.

When optimizing a process, the goal is to maximize one or more of the process specifications, while keeping all others within their constraints.

QAtive can help you with:

  • Migration and/or integration of your processes due to mergers, take-overs, etc.
    Identify best practices from either worlds, or work towards the chosen golden standard.
  • The optimization of your process concerning Portfolio Management, via a web based solution. Managers continuously face challenges in prioritizing resources and deciding whether to start, continue, speed up or delay project development. This tools enables smart guidance for strategic decision making at any time, balancing risk & value, using actual insights.
  • The design of your Electronic Document Management System, for the creation, review & approval, consultation of documents. Like the following examples:
    • (non)-clinical, regulatory & quality (CM&C) documents: electronic Trial Master File solution, eCTD submissions (e.g. Investigational New Drug application, Marketing Authorization Application,…)
    • Legal documents
    • Quality Management Documents

Such a system is not only a big benefit in the content management of your critical business assets. It can also make life easier during IPO and/or alliance/cooperation due diligences.

 

"Shortly after Movetis was founded, Petra was asked to design our Movetis' Electronic DOCument Management System (MEDOC). This system was deemed critical to keep a corporate memory, to reach the high standards required in document submission to Health Authorities and to use it as an internal alignment tool behind SOPs and operational strategies. In a hectically growing organisation and after three months this system was operational and enabled the company onwards to manage its business critical documents in a more consistent and audit trailed way. MEDOC played a crucial role in a number of company milestones including our filing of Resolor, our IPO process, several due diligences by pharma players and the eventual take-over by Shire Pharmaceuticals. Furthermore, Petra diligently created from scratch a robust, tailor-made Quality Management System reflecting the character of Movetis, a biotechnology company outsourcing most of its operational activities. Three internal audits and audits by external pharma partners confirmed the robustness of the QMS. During our cooperation, I got to know Petra as an honest, result driven, loyal and knowledgeable person."

Dirk Reyn, Managing Director Shire-Movetis NV - May 23, 2011

 
 

Our Services at a glance...

QAtive is an independent company which operates internationally within the Health Care & Life Sciences industry. QAtive offers you services related to Quality Assurance, Process Optimization and Training.