Drug and device companies must negotiate a number of regulatory and legal hurdles before launching a product globally. They cannot risk having vague or inaccurate translations jeopardize their efforts.

Even for markets where regulations are less stringent, there are still a number of marketing and public relations issues to consider. A sloppy translation can quickly erase significant investments in marketing and brand building.

ForeignExchange pioneered Multilingual Compliance while working with organizations in regulated industries.

Multilingual Compliance is based on the proposition that quality does not exist without rigorous systems—systems that are not merely effective, but are documented, measurable and auditable.

As competition abroad gets more intense, organizations who rely upon the Multilingual Compliance Process will gain a competitive advantage.

ForeignExchange offers ISO 9001:2000 certified, highly proceduralized systems, with a clear audit trail and defect-measuring milestones. All of our software-localization, web-globalization, and technical-translation services adhere to this quality standard.

As part of the ISO 9001:2000 certification process, ForeignExchange has designed and implementation of a Quality Management System. Many standards have already been documented in an ISO-compatible format and implemented as part of a Quality Manual.

Do you have an upcoming project and need some idea of the associated costs?

ForeignExchange can provide you with a quick estimate, no strings attached. Complete and submit the quote request form and we will contact you with an estimate and schedule.

The Multilingual Compliance Process (MCP) relies on three stages to ensure the quality of the final deliverable product.

Compliance Translation Certification

Given the strict regulatory requirements and high quality standards that companies in compliance-intensive industries face on a regular basis, ForeignExchange has developed its own translator certification program. This demanding certification ensures that linguists:

• are professional translators and editors
• are working in their native language
• possess significant experience in their field of specialization
• pass a rigorous screening and testing process
• receive feedback on the quality of their work on a continuing basis

Control and Supervision

At the heart of MCP is a double-check mechanism. Simply put, every action is double-checked by a second person, following defined procedures and authorization levels.

Although deceptively simple, the logistics involved in organizing a double-check procedure can be daunting. For example, a nine-language project containing three documents may undergo seven actions. That is 189 discrete tasks (9 x 3 x 7) that must be performed and double-checked!

MCP builds in a sophisticated infrastructure to organize this effort, to ensure completion of each action and to collect data, thereby ensuring that the final deliverable matches the expectation set forth in the initial project planning.

Tracking and Measurement

Unlike other translation companies, we don’t just talk about quality, we measure quality. One key aspect of MCP is the careful tracking of defect and performance data.

Within the framework of our ISO 9001:2000 certified processes, ForeignExchange clients have the ability to raise nonconformances. ForeignExchange monitors reported nonconformances per project, per client, per document and even per word.

The ForeignExchange team reviews quality data on a quarterly basis as part of our continuous improvement initiative. The data is also reviewed during periodic meetings between a client’s project team and ForeignExchange, and clients have found the regular quality updates submitted by ForeignExchange to be helpful in tracking their own improvement goals.