Life Sciences projects are complex in nature and close collaboration between the client and the design firm are essential for successful execution. In recent years, FDA has increasingly observed cGMP violations involving data integrity during inspections. These data integrity-related violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees.
What are the Regulatory Agencies’ Expectations?
The FDA Data Integrity and Compliance Draft Guidance for Industry was released in 2016 with the purpose of clarifying the role of Data Integrity in current Good Manufacturing Practice for drugs as required in 21 CFR parts 210 and 211.
The FDA, MHRA, and the EU expect that life sciences companies who manufacture or distribute pharmaceuticals within their jurisdictions retain complete and accurate records, including all raw data, of their operations. These records must be readily available to regulatory inspectors during inspections.
By recording and maintaining this data, manufacturers have a basis for assuring:
- Product identity
- Strength
- Purity
- Safety
If the integrity of this data is found to be non-compliant with regulatory requirements, regulatory action from these agencies may follow.
Design Group and Data Integrity – Assessments
Design Group supports our clients’ Data Integrity programs with the execution of formal gap assessments, remediation strategy development, and resolution implementation.
Our team has provided Data Integrity assessment and remediation support across the US Life Sciences market segment, from coast to coast, and within the Pharmaceutical, Biotech and Medical Device industries.
Design Group’s process is to evaluate our clients’ applications of data into the following nine key areas of focus and assess each one in detail, to identify gaps in the application of the Data Integrity principles.
The Nine Key Areas of Data Integrity
- Access and Security
- Primary Records and Data Ownership
- Paper Records
- Record Creation and Review
- Audit Trails
- Validation
- System Clocks
- Record Retention
- Back‐Up/Archival
The Unique Design Group Advantage
As a result of the diversity of services Design Group can provide to industry, and through the partnership of our Control System Integration, Strategic Information Technology Consulting, and Regulatory Compliance Practices, our team is uniquely positioned to support data integrity assessments, remediation strategy development and resolution implementation across all levels of our clients’ manufacturing platforms.
Learn more about Design Group projects on Data Integrity implementation for manufacturers in the Life Sciences industry. Click here.
