GMP Analytical--Computer Data System

PharmaCore utilizes Agilent's fully Part 11 compliant Enterprise Content Manager (ECM) as our electronic data management system to assure the integrity of your critical data.
Our IT department backs up all of our data on a daily basis. The data is kept at a secure off-site location, thus guaranteeing protection against catastrophic data loss. It can be retrieved whenever needed.

The entire ECM system is on an uninterruptible power supply and generator back-up for added data security. The ECM system allows us to efficiently store, retrieve, and report your information when you require it.

Working in conjunction with ECM is the Agilent ChemStation computer data system for acquisition and analysis of chromatographic data. Data analyzed and managed through ChemStation has a complete audit trail and is fully version controlled, making in-depth inspection of your data a straightforward exercise.

PharmaCore's scientists bring a wealth of real-world experience to the table to help meet your needs. Our analytical operations are based on written, detailed SOPs and stringent quality assurance practices, and all of our work is performed in compliance with cGMP requirements.

We welcome client visits or audits to review our standard operating procedures, to verify our strict compliance with current GMPs, and to demonstrate our experience in stability studies.
For more information on our method development and validation capabilities or any of our pharmaceutical capabilities, please call PharmaCore at 336-841-5250, extension 159 (Mark Shapiro, Director GMP Analytical) or extension 101 (Kelly Tilyard, Marketing Manager).