We conduct software validation for regulated as well as non-regulated industries. A team of validation specialists who are well trained by great authorities like DA, WHO, CFDA, and Health Canada. They are especially well-equipped
with knowledge of laboratory informatics systems, instrument systems, and computing environment validation.
As the pharmaceutical industry is most significant and sensitive compared to all other industries, business managers should perform computer system validation for their software. This confirms the completion of tasks a
system was developed for, has better control over user operations and reaches all the rules and standards fulfilling security requirements.
Xcel LifeSciences promises to maximize the value of your compliance investment by testing the level of risk and cost of the risk to the organization. With a thorough understanding of system validation requirements, we offer
the following services:
Business Process Maps
Requirements document (User, Functional and Design requirements)
Validation Plan
Risk Assessment Report
Developing Unit Testing Form (UTF)
Dry run of UTF
Validation Scripts
Execution of Validation Scripts. (IQ, OQ, PQ)
Traceability Matrix
Standard Operating Procedure, Work Instructions, or User Manuals.