Validating corporate computer systems
Our Compliance & Validation Services Your trusted partner for Computer System Validation and Software Testing Services.
Stelex Compliance Services provides superior service and expertise required to meet all of your Computer System Validation and Software Testing needs.
Assist in periodic assessments of globally controlled IT regulated activities.
Those who join Emergent Bio Solutions feel a sense of ownership about their future.
Our customers include all of the global pharmaceutical and biotech companies, as well as government agencies, leading hospitals and academic institutions.Life Science companies must perform validation activities on an ongoing basis in order to reduce compliance risk, ensure quality, and maintain data integrity.A “Computer System” in an FDA regulated laboratory is more than just computer hardware and software – it also includes any equipment and instruments linked to the system, as well as the trained staff that operate the system and/or equipment using Standard Operating Procedures (SOPs) and manuals.The validation process is designed to provide a high degree of assurance that both new and existing computer systems will consistently fulfill their intended purpose by producing results which meet predetermined specifications and quality attributes – accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.As scientific applications constantly evolve to keep up with the needs of the people and businesses that use them.