Quality Management Systems development & implementation.
Based on our long time experience in Quality Assurance / Quality Control and assisting clients in implementing different technology solutions, We have developed a set of extremely flexible Quality Management functions with most appropriate modules for a small to medium sized pharma or medical device company. See the detail of our QMSuite.
Innovative Quality Agreement Management.
Since the publication of the FDA's Guidance on Quality Agreements, we have been helping clients develop and negotiate these critical documents. In order to provide the best possible service to our clients we have developed a Software as a Service solution that allows our clients to manage all of their Quality Agreements interactively with their suppliers. See our QAG-Manger page for details.
Spreadsheet based testing for the GMP Laboratory
PDA's TR80 has quickly become the defacto standard for assuring compliance with regulatory expectations for Data Integrity. We have developed the only commercially available solution that combines the use of your original spreadsheet in a controlled and audit trailed workbook with fully compliant Electronic Signatures for the Tester and Reviewer all in one place. See our TestSheet-Manger page for details.