In response to the growing number of data integrity risks and observations in the industry, in April 2016, the FDA released the draft guidance “Data Integrity and Compliance with CGMP Guidance for Industry” to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs. According to the draft guidance, the FDA expects all data, regardless of format (paper and electronic) be reliable and accurate and recommends that companies implement meaningful and effective strategies to manage data integrity risks based upon process understanding, management of technologies, and business models.
CSols can provide experienced resources to conduct a Data Integrity assessment of your informatics lab space with a focus on the completeness, consistency, and accuracy of regulated data collected, maintained, analyzed, and or reported by your computer systems.
Our assessments are conducted against the FDA draft guidance, along with our knowledge of the informatics space, software, regulatory requirements, and industry best practices.
The goal of each assessment is to ensure that data are ultimately Attributable, Legible, Contemporaneously recorded, Original (or a true copy), and Accurate (ALCOA).
Our Consultants work with your staff to address the following items during an assessment and help you identify data integrity risks and gaps, and recommend corrective actions and remediation activities.
- Review of existing Software Validation Lifecycle policies, SOPs, etc.
- Identification of paper data, electronic data, raw data, and static and dynamic data
- Intended use of computer systems (e.g., SOPs, workflows, etc.)
- Use of notebooks and forms associated with computer systems (if applicable)
- System security and access to data (e.g., user types, groups, roles, accounts, etc.)
- Electronic signatures and audit trails
- Data retention policies and availability of data
- Data backup, archive, restore and recovery processes
- Training for support and use computer systems that collect, generate, store, analyze, and/or report regulated data