USP establishes compliance standards with centralized management solution

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines and food ingredients manufactured, distributed, and consumed worldwide. In fact, USP’s drug standards are enforced in the United States by the Food and Drug Administration and used in more than 140 countries. While USP was familiar with setting standards for food and medicines, it needed help internally with improving and standardizing contract management.

Contracts were being reviewed and handled manually and emailed to legal. Since there was no centralized database, managing templates being mandated by legal was impossible.

Since there was no contract manager, departments were relying on legal counsel to review all organizational contracts. A typical example of contract: HR drafts an agreement using an old template, then legal would point out that it’s outdated, and they would need to start the process all over again.

With no central repository for storing and managing contracts, USP employees were saving contract documents on different drives throughout the company creating storage redundancy and risk issues. Contracts were also being auto renewed with no alerts or reminders. While all these challenges existed domestically, USP was expanding globally, working internationally through agreements with other pharmacopeias, as well as regulatory bodies, manufacturer associations and others. USP’s footprint was also becoming more global every year with the establishment of an international office in Switzerland, and offices and laboratories in Brazil, India, and China.

Involved from start to finish in CLM implementation, Ms. Zhao, Senior Contract Manager – Global Legal Affairs, notes, “The centralized contract database provides big benefit to USP. We can now go into the system from anywhere, make addendums, amendments, and can draft from original documents. We are currently trying to make a database for each department.”

USP also built policies around compliance. They mandated throughout the company that contracts must be entered into the system.

There are currently (approximately) 500 contracts entered per year, but with international sites that number is increasing. Some of the key functionality focuses on solving their biggest problems including contract creation, template creation, approvals, automated alerts, reporting, and the use of third-party paper.

Corcentric CLM is currently being used by every functional department at USP and handles all contracts for them. This encompasses a very wide group globally across the organization including IT, Facilities and Administration, Sales, Marketing, Science, and Government Grants. All these departments are also actively managing several types of agreements including corporate communication agreements, training agreements, sales agreements, QA audit agreements, and confidentiality agreements.

Over the past several years, Corcentric has played an active part in helping USP find new approaches to meet their contract management needs, from departmental requirements to enterprise-wide approaches.