Solutions and Services


Quality Systems Compliance Assessments and gap remediationWe can help you understand cGMP Laboratory compliance requirements including; Data Integrity Standards, Computer Systems Validation & 21 CFR Part 11 compliance. We can provide you with a customized plan to address your organization's specific risks. Finally, we have the people, processes and technology to remediate any risks that you need help addressing.

Supplier Quality Management SupportWe can support your entire Supplier Quality program from Quality Agreement development thru compliance monitoring. Often overlooked Specification management is a critical part of assuring compliance and minimizing risk.

Pre-Approval Inspection (PAI) Assessments and gap remediationWe can assess your Quality Management System processes and documentation including; Document Management, Change Management, Incident (Deviation/CAPA) Management, Learning Management (Training). We can help your determine the optimal balance of People, Processes and Technology to support your organization thru your PAI.


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.