Founded in 2006 by Dr. Kimberly Brown, Amethyst Technologies provides quality program development and comprehensive compliance services and products to the biotechnology and pharmaceutical, healthcare, food and beverage industries, as well as to the federal government.  Core services include quality program development worldwide, custom quality management software, consultation for sustainable labs, regulatory submissions, equipment calibration and validation, process optimization and validation, auditing, high purity utility design services and qualification, clean room design and commissioning, environmental monitoring system management, and non-compliance troubleshooting.

To deliver “rock solid” quality system products and services to our customers.

Our Commitment to Quality and Customer Satisfaction

By “rock solid”, we mean accurate, dependable, and of the highest quality every time.  We want to ensure that no project in which we participate fails due to poor quality.  Amethyst Technologies is dedicated to helping our public and private sector customers address a variety of compliance issues, from equipment validation and calibration to the implementation of entire quality systems.  We are committed to delivering beyond expectations and providing solutions with real benefit.  This can be seen in our approach to quality throughout all aspects of our business.

Our Approach

It’s really quite simple.  We approach each contract systematically: Listen to the customer to discern their needs.  Assess the regulatory requirements.  Conduct interviews and/or gap analyses.  Develop a solution by employing our industry knowledge.  Use continuous feedback to provide fine-tuning.  We work closely with multiple areas of expertise within the customer’s organization to ensure cohesion between laboratory staff, quality representatives, information technology experts, and ancillary support groups.  We request commentary on our work on a regular basis to ensure that adjustments are made in a timely manner and do not affect future performance.  Amethyst staff also think “outside the box” to build creative and customized solutions to the obstacles facing our customers.

Our Employees

Our employees have diverse backgrounds in various regulated industries, with a commitment to honesty, integrity, and sensitivity to customer needs.  Amethyst immerses our employees into a company culture of continuous learning and training, developing their knowledge base, and growing their professionalism and leadership and communication skills.  Staff members receive training on regulatory issues and requirements, as well as procedures pertaining to their job functions.  Amethyst also maintains a technical library for self-teaching and reference and encourages employees to seek out additional material specific to each project.  Employees are groomed to act as points of contact at customer sites and to serve as liaisons and coordinators for various projects.

Our Customers

We are committed to leaving our customers with a product which can be implemented and maintained to the benefit of their company.  We believe in the timely supply of finished products, whether they be calibration certificates, audit findings, standard operating procedures, forms, protocols, reports, manuals, or other types of documentation, that have been thoroughly reviewed both by our quality group, as well as by the customer’s designated reviewers.  When Amethyst completes a project, what is left behind should be exactly what the customer wants while still being able to withstand regulatory scrutiny.  We can also school customer representatives on why certain information has been included in the documentation and how that relates back to applicable regulations or industry standards.

Our Operations

No company can succeed without a strong infrastructure.  The “central nervous system” of Amethyst is our operations group, whose responsibility is to coordinate and organize all transactions with customers, suppliers, and co-workers in such a way that these interactions are transparent and not distracting.  Treating each client as an individual and ensuring that the products and services provided by Amethyst meet or exceed appropriate regulations and customer requirements is crucial to customer satisfaction, repeat business, and a positive industry reputation. Our internal review of each deliverable, whether a corporate Quality Management System, a qualification package, or a single equipment calibration, guarantees that our customers get what they ask for and what they need.

Kimberly Brown, President and CEO

Kimberly Brown, founder and CEO of Amethyst Technologies, began working in the biotechnology compliance industry in 1998 as an intern for Cell Systems, Inc. while pursuing her doctorate degree.  At the time, the company had one employee, the owner, and provided services to Walter Reed’s Pilot Bioproduction Facility (WRAIR PBF).  After completing her studies, Dr. Brown continued to work for Cell Systems as validation manager for WRAIR PBF and as Cell Systems’ operations manager.  She increased the project scope at WRAIR PBF to include quality system development, custom software to support FDA regulated activities, and the validation master plan to ensure sterile vaccines, increasing the contract with the addition of validation services, managing the environmental monitoring system, and commissioning for clean rooms and utilities.  Dr. Brown purchased the contract rights from Cell Systems in February 2007, and received the contract to continue providing services to WRAIR PBF.  Since then, Amethyst Technologies has experienced steady growth in employees, client base, and revenues.  Under her guidance, Amethyst Technologies has grown from two employees to 15 with a projection of 20 additional employees before the end of 2010.