We have been working with and supplying systems to the Pharmaceutical Industry over the last 10 years. Consequently, we have fully implemented Software Development Standards that enable us to meet the stringent demands of Validation. As a result, we are now an approved supplier of Software Systems to Glaxo SmithKline PLC. and are regularly audited.

Tri-Star Systems provide full documentation covering Functional Design Specifications, Installation and Operational Qualification protocols and on-line User Manuals. This ensures that our systems meet the requirements of the standard regulatory authorities.

Standard ESCROW agreements are available to allow the end-user access to the source code thereby protecting his investment.

The logon and electronic signature systems have been designed based upon 21 CFR part 11.

Modifications to any part of the Formulae are recorded in a history file thus providing full traceability. These entries indicate the details of the change along with the user responsible and the date/time the change was implemented.