The Company

Ridge Pointe Consulting, Inc. (RPCI) is a small business, woman owned company that provides validation and consulting services to the Pharmaceutical and Biopharmaceutical industries. The strength of RPCI comes from industry experience, combined with industry-related strategic partners.

Company Profile:
RPCI was founded in 2002 in Bradenton, FL, to provide high quality, specialized compliance services to the Life Sciences industry to increase pharma clients’ rate of return on compliance investment. RPCI is a privately owned, small business, woman owned corporation, which has established strategic partnerships with Information Technology (IT) and compliance firms in order to provide the highest quality of services to our pharma clients. RPCI is directed by 2 individuals and employs experienced compliance consultants nationwide on a project basis to provide the highest quality compliance services in the regulated industries. Currently, RPCI is part of the steering committee for a large pharmaceutical company, providing guidance and expertise in the area of laboratory information management systems (LIMS). RPCI is also present at another client, providing compliance services for a large enterprise application that is being implemented. Our goal is to remain a specialized, client focused, organization that will continue to provide excellent compliance services at an extremely competitive cost. The focus of this organization is to partner with pharma clients and to develop a long term relationship so that the client can become the industry example on how to implement a highly compliant IT based project.

Since 1996, RPCI’s principals have been involved in the build process of major pharmaceutical companies Sales Force Automation (SFA) laptops and SFA applications, have performed Quality Assurance testing on laptop builds, and have helped map, develop and validate pharmaceutical marketing and sales processes for large pharmaceutical organizations including, but not limited to, Hoffmann-La Roche, Wyeth ,and Whitehall Robins.

It is standard RPCI policy to follow both the FDA’s Guideline for general principals of Software Testing and GAMP 4’s outline of SDLC. Not only has RPCI performed SDLC audits on software clients, but RPCI has been instrumental in helping shape many corporations’ SDLC policy in order to comply with federal regulations.

RPCI has always followed the guidelines in gathering and defining user requirements as per GAMP (3 and 4) policy or per the client’s SOPs. For example, one of the principals of the company was instrumental in guiding a client in user requirements gathering and definition for a Siebel pharma implementation. Recently, RPCI completed requirements gathering and definition for a global laboratory Information Management System (LIMS) phase 2 implementation for a major pharmaceutical company.

RPCI has 21 CFR Part 11 experts who have been involved implementing the regulations since 1997, when it came into effect. At the time, SFA and CRM applications were being revisited to see if there were any changes required to be in compliance with 21 CFR Part 11. The effort revealed that there were substantial changes that needed to be made, both on the front end and on the back end of these applications. RPCI’s experts have had hands-on involvement for many years with pharmaceutical companies like Hoffmann-La Roche, and suppliers like Sales Technologies (now IMS Health) and Dendrite, modifying their applications and procedures to become Part 11 compliant. In addition to SFA/CRM applications, RPCI’s experts have also been involved with validating LIMS, laboratory applications (e.g. Millennium), Building Management Systems, and many other systems that are subject to Part 11. They have been speakers in the industry at trade shows like ISPE Tampa Winter Conference, 2004 and PDA Conference, 2002, and have done presentations for smaller groups in Pharmaceutical companies (e.g. Purdue Labs).

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