Data Integrity Program
Regulatory agencies worldwide charge manufacturers in the life science industry with assuring that their products are manufactured in a manner that protects patient safety, product quality and data integrity. These concepts form the bedrock of the Good Manufacturing Practices (GMP) that govern the industry. Grantek offers data integrity auditing to help establish a baseline and identify gaps in data integrity that could result in failure to retain adequate records and/or potential regulatory agency observations.
Grantek’s Data Integrity audits cover more than 21 CFR Part 11 compliance; we assess the computerized systems using checklists and methodologies that follow ISPE GAMP guidelines to ensure we evaluate the customer’s systems against all applicable regulatory controls. The audit includes a risk rating for each identified item, as well as a remediation list to help prioritize corrective actions. This serves as the basis for a remediation plan to provide a path forward to meeting the data integrity guidelines.