It is of fundamental importance that the scientific data contained in reports produced by both regulated and accredited testing and calibration laboratories are both reliable and trustworthy.This is especially so when the information contained is used to determine that medical and veterinary products conform to established specifications and are safe to release for commercial sale.
The trustworthiness and reliability of data and records that are created during the manufacture and testing of regulated products attracts considerable attention during inspections carried out by the regulatory agencies , clients or customers.
Stericycle GxP and our team of consultants can assist you in managing your data to assure its reliability and trustworthiness with a comprehensive data integrity management system.
We apply the fundamentals and principles of data integrity management and identify any vulnerabilities which may expose the trustworthiness and reliability of your data.
Our data integrity audit will discover if activities are being performed in compliance with data integrity principles. In addition, we will be looking to see that staff who are responsible for reviewing data and records understand the fundamentals and principles of data integrity.
We create policies & procedures as well as fostering a culture built on reliable data integrity management. Periodic audits can also be conducted to monitor the effectiveness of data integrity management.
Stericycle GxP will prepare a thorough investigation plan that will identify the nature, scope and root cause of data integrity issues. Our remedial plan corrects all compromised reports, data and products and will prevent any future lapses.