DPT Enhances Compliance with ECM Software

DPT Laboratories, Ltd. has recently adopted an electronic enterprise content management (ECM) system that enhances its ability to maintain secure, organized documentation in accordance with the FDA’s current Good Manufacturing Practices (cGMP) regulations.

“DPT is a contract service provider providing drug and device development and manufacturing services for our clients, and maintaining regulatory compliance is a key factor for us and for our clients,” said, Kay Mary Harrell, senior director of regulatory affairs for DPT, a DFB company. “This new software system implementation provides our clients another level of assurance that DPT invests in its infrastructure and desires to be pro-active when it comes to compliance.”

The ECM software provides assurance that the manufacturing personnel are using the most updated version of procedures. This ECM system also provides a clear audit trail with electronic signatures showing everyone who has modified a document. The EMC system also allows DPT to create electronic technical documents for clients, which its clients can include as part of their submission package to the FDA.