Welcome To QAtive
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. This webpage introduces you to the person behind QAtive.
QAtive was founded in September 2010 by Petra van der Bos.
Petra started her career in the pharmaceutical industry in the early nineties, as Biometrics Assistant for Roussel Uclaf in The Netherlands. In 1997 she made a move towards Clinical Operations. Till 2005 several positions with increasing responsibility (e.g. Clinical Research Associate, Clinical Research Manager, European Study Manager, Clinical Project Leader) were held, for all the successors of Roussel Uclaf (Hoechst Roussel, Hoechst Marion Roussel, Aventis and Sanofi-Aventis)
In 2005 she moved to Belgium and started working for Johnson & Johnson as a Global Trial Manager. Then in April 2007 she got the opportunity to join Movetis, J&J’s successful spin-off, fairly quick after its start-up. Petra’s major achievements for Movetis were:
- the set-up & maintenance of Movetis’ Quality Management System covering all processes (data management, clinical operations, pharmacovigilance, regulatory, quality assurance, non-clinical, CM&C, etc….) of a pharmaceutical company.
- and, the creation & implementation of Movetis’ Electronic Document Management System.
Based on the experience gained over all these years, Petra founded QAtive in order to share this experience with different clients and to commit herself to the success of these clients.
In case you are interested to see her complete resume, please feel free to request a copy via the Contact form.
Quality Assurance
In the much regulated industry of Health Care & Life Sciences Quality Assurance cannot absolutely guarantee you to produce quality products. However, via systemic monitoring and evaluation of various aspects of your project, service or facility you maximize the probability to attain minimum standards of quality.
Your success can result from implementing & maintaining a Quality Management System that is designed to continually improve performance while addressing the needs of all interested parties.
QAtive can help you with the following solutions:
- creating (or improving) & implementing your tailor-made Quality Management System
- performing audits e.g. investigator site, process, supplier/vendor, pharmacovigilance, phase I unit, etc.
- implementing your Corrective and/or Preventive Action Plan
- writing and/or updating your Quality Management documents e.g. Standard Operating Procedures, Working Instructions, etc.
- Preparing your company for an upcoming inspection or audit.
- hands-on support to your Quality Assurance Department, e.g. when temporary understaffed.
Petra has proven during her employment as QA Manager at Movetis that she was the right person to design and set-up a well-working Quality Management System, which enabled the company to be accepted by important pharmaceutical partners. Now that she started her independent company, she can be highly recommended to work on quality management projects for other companies as well. Petra has excellent knowledge about the Clinical QA processes and regulations, is pleasant to work with and brings added value to your company (October 26, 2010).
Process Optimization
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 (May 23, 2011).
Dirk ReynManaging Director - Shire-Movetis NV
Training
Training is an important part of Quality Management. In every inspection the training curricula of your staff will be reviewed. Keep your staff up to date on regulations, your own company procedures, etc.
QAtive can provide tailor made in-house trainings related to:
- Good Clinical Practice
- Company Specific SOP's
- On the job coaching of Clinical Research Associates, Clinical Trial Assistants, etc.
- How to prepare for an inspection/audit?
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.
Info
If you have a specific question regarding the services we are providing, feel free to reach out to us using the contact request form.
About us
We are a small independent company, specialized in services related to Quality Assurance, Process Optimization and Training.
Contact
QAtive BV
Kasteeldreef 37
2970 Schilde
+32 473 13 11 40
Copyright © 2020 QAtive BV
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BlueCie BV