Data Integrity Insights

Ensure Data Integrity in Laboratories

Data integrity is paramount in today's digital world. Presenting uncompromised results and maintaining compliance with the latest regulations and standards—including those issued by the pharmaceutical, environmental and food regulatory bodies (e.g., FDA, ISO, USDA, Annex 11)—is a necessity. The traditional approaches to laboratory data integrity are not enough to meet today's increased scrutiny of computerized systems and the terabytes of data they produce. To successfully present your results, you must be prepared to prove that your data have not been compromised—and that can be a challenge.

Data Integrity Insights helps your lab stand up to any regulatory examination by keeping you informed about the latest global enforcement trends, including those from the FDA, and the strategies you can use to stay compliant.

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Data Integrity Insights: Articles

Filter by: All Acquisition & Instrumentation Analysis & Reporting Inspection Readiness Data Management & Retention Cloud

Inspection Readiness

A Risk-Based Approach to GxP Computer Systems Validation Using Critical Thinking

Traditional CSV follows a static, document-centric approach using checklists, templates, and predefined procedures. By embracing a risk-based approach rooted in critical thinking and allocating appropriate resources, we naturally achieve success and inspection readiness.

Analysis & Reporting

5 Tips for Avoiding Data Integrity Issues in Chromatographic Integration

Data integrity has been a hot topic long enough that most GxP chromatography labs have begun to address the core issues, usually with good success. However, there are a few areas where ensuring data integrity remains an elusive goal. One such is chromatographic integration and data interpretation.

Analysis & Reporting

CDS Audit Trail Reviews 101

CDS audit trail review is an absolute requirement for keeping your lab audit-ready and continuously compliant. But new technologies and processes are available to speed up the ATR process, saving time, money, and sanity. Get tips for accelerating audit trail reviews without compromising on accuracy, data integrity, or compliance.

Analysis & Reporting

Calculating & Reporting Results: 4 Tips for Preserving Data Integrity

There are a few critical choices to be made around calculation and reporting that impact compliance, trustworthiness of results, and even the reputation of the lab. Get tips for maximizing lab efficiency and data integrity simultaneously.

Analysis & Reporting

5 Ways to Maximize the Effectiveness of Second-Person Reviews

Second-person reviews should be your first priority in ensuring data integrity. But how can you help second reviewers do their jobs faster and better? What are the key considerations for maximizing their effectiveness and job satisfaction? Get information and guidance about optimizing your second-person review process.

Acquisition & Instrumentation

Stopping Data Manipulation Tricks in their Tracks During Instrument Setup and CDS Data Acquisition

Correct, complete, and accurate data acquisition is a key component of data integrity. Get advice on how to identify errors and thwart attempts at data manipulation.

Inspection Readiness

6 Pointers for Passing Your Next Data Integrity Inspection

Preparing for a regulatory inspection is easier when you understand why data integrity inspections are becoming more commonplace today, what the auditors are looking for, and how to answer their questions. Get tips for simplifying, expediting, and surviving your next audit.

Cloud

CDS in the Cloud: Making the Shift from Why to How

The transition to a cloud-based model for CDS can improve many lab processes without compromising data integrity. However, there is a lot to learn before the journey can begin. Learn the benefits of moving CDS to the cloud and the key considerations in getting started.

Data Management & Retention

Organize Your Thoughts about Data Management

Determining how to define data management can be daunting enough, let alone figuring out to how to achieve it in a regulated analytical lab environment. Learn 5 key considerations for effective data management—and how superior data management can translate to higher data integrity.