Metadata, or "data about data," has become a component of many regulated GxP activities conducted electronically. Just like the records it's attached to, metadata has significant regulatory impact and brings its own set of compliance risks.
While FDA's 21 CFR Part 11 defines the requirements for electronic records in detail, the requirements pertaining to metadata are less clear. We've taken a closer look at what specific regulatory impact metadata has and the actions manufacturers should take to mitigate them.
A Corrective and Preventive Action (CAPA) system is a roadmap of processes regulators expect manufacturers to follow to identify and solve compliance problems. As such, they're a critical point of focus during FDA inspections and quality system audits.
More than just a mandated requirement, CAPA systems are the means by which manufacturers can improve their quality system to mitigate risks and avoid quality-related issues in the future.
An effective and compliant CAPA system requires a strong set of data in order to detect problems, find and implement solutions, and document findings and subsequent changes.
Since FDA investigators, auditors, and executive management all rely on CAPA documentation for reviewing compliance issues, we've summarized the the five essential steps to ensuring your CAPA system is both compliant and effective.Continue Reading
Data integrity means different things to different people. To the IT Security group, it’s the assurance that information can be accessed and modified only by those authorized to do so. To the Database Administrator, it’s making sure data entered into the database are accurate, valid, and consistent.Continue Reading
Data integrity deficiencies are now among the top compliance issues cited in FDA warning letters and Form 483 inspectional observations at manufacturing sites around the world.
Despite a number of guidance documents and public statements explaining what regulators expect from manufacturers, many companies continue to struggle with basic data integrity problems.
While data integrity is a complex area of compliance, there are a number of simple ways to help ensure your data meets the fundamental ALOCA attributes and mitigate data integrity risks. We've highlighted six of those actions below.Continue Reading
Data integrity has become a major priority among regulatory investigators and audit trail deficiencies in particular have been cited in a growing number of enforcement actions.
While many firms understand the importance of configuring their systems to ensure audit trails are adequate and meet regulators expectations, many others still struggle to maintain electronic records with a complete and compliant audit trail.
Validated computer systems with enabled audit trails are necessary, but not sufficient, to meet global regulatory good documentation practice requirements for electronic records.Continue Reading