Consulting Services
KRA is a recognized industry leader in the qualification and validation of all facets of a facility start-up (equipment, computer systems, utilities and laboratories). We utilize the most current regulatory requirements and industry trends to develop the Validation Master Plan and design the Validation Protocols. From project inception to completion, we will provide you with a complete validation package, including protocols, reports and if necessary, maintenance, cleaning, operating and calibration procedures.
Delivering solid proven results to your requirements, we work closely with our clients to provide the most cost-effective and complete package. Evaluating your resources and assessing your goals is our priority. Your needs and quality expectations are always at the forefront of our efforts.
In addition to providing world class compliance services, our engineers and alliance partners can provide you with a full spectrum of engineering services.
From Validation Planning to the development and execution of the Validation Protocols, our strength is the ability to provide tomorrow's technology a new partner.
Equipment / Processes
A partial list of recently qualified / validated equipment and systems include:
UTILITIES
BIOTECH EQUIPMENT
STERILE EQUIPMENT
AUTOMATION / COMPUTER EQUIPMENT
SOLID DOSAGE EQUIPMENT
FILLING / PACKAGING EQUIPMENT
SYSTEMS / PROCESSES
LABORATORY EQUIPMENT
|
VALIDATION
COMPLIANCE
ENGINEERING SERVICES
PLACEMENT SERVICES |