Audit Trails provide quality control and regulatory compliance to retain ‘License to Operate’ and ensure data integrity.

In a highly regulated industry, it is a common occurrence to be audited. Therefore, we work with our clients to ensure they maintain their manufacturing compliance by providing them with routine Audit Trail reports. These reports demonstrate compliance of client’s operational data infrastructure and verify their change control integrity.

TQS Audit Trail reports help contextualize all manufacturing system changes with respect to our client’s change control system providing them with peace of mind, and clear value-added mapping of information.  Our reports support operational methodologies that provide clear view of breaches and recommends required improvements and actions in manufacturing. These include:

• What was Changed? By Whom? When? Change Control Number?
• Authorised Versus Unauthorised Changes
• Actions Taken & Recommendations

Audit Trails provide quality control and regulatory compliance to retain ‘License to Operate’ and ensure data integrity. In the last 20 years, there has been an increase in operational data integrity related audits and observations. As a result of the increased regulatory action, there is a race within the industry to implement adequate data integrity controls.

Working with TQS, we will ensure that you meet operational governance, risk, and compliances expectations. Most companies struggle with defining adequate risk-based strategies to data integrity that meets manufacturing regulatory requirements. Not only do we support this strategic development, we also provide insight into all changes made, compare and contrast with authorised changes.

Having robust Audit Trails and Data Integrity SOP in manufacturing can help mitigate on unnecessary cost and avoid strain on resources. Audit Trails services also aligned with InforSec and CyberSec expectations to protect your business records, personal data and digital information and assets.

To bolster compliance and provide demonstrable steps to prove operational system integrity, site stakeholders must ensure they can showcase visibility internally and externally. We will review and verify no unauthorized changes have been made to the system.

References:

• Data Integrity and Compliance with Drug CGMP Questions and Answers Guidance for Industry: https://www.fda.gov/media/119267/download
• Part 11, Electronic Records; Electronic Signatures - Scope and Application: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application#iiic

To learn more, contact us for a free consultation.