An Assurance of Quality

From acquisition to data delivery, Spacelabs Healthcare follows strict regulatory guidelines to consistently ensure the highest quality data possible. Our quality assurance methods and processes are continually adapted to changing regulatory and pharmaceutical industry requirements. Quality checks are incorporated throughout data processing from receipt of data to delivery of data to the sponsor to final database lock.

At Spacelabs Healthcare, the quality culture begins at the top of the organization with a quality management system that uses regulatory-compliant standard operating procedures. Routine internal process audits and periodic third party evaluations are conducted to monitor quality system effectiveness and SOP adherence. In addition, clinical trial computer systems are validated and maintained under a controlled change management system until retirement.

Spacelabs Healthcare preserves data integrity from acquisition to delivery through a diligent process including edit checks, multiple quality controls at all stages and final quality assurance review.