How to Nail Data Integrity During Drug Development
In the 2010s, regulatory agencies made data integrity of computerized systems a central concern. While data integrity is not a new topic — electronic-specific enforcement began in the U.S. in 1997 — pharmaceutical companies now face heightened scrutiny over their practices. PerkinElmer realizes the challenges that accompany documenting electronic processes and has created a solution portfolio that includes OneSource Laboratory Services.
ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate) Compliance:
Lab efficiency and compliance should be priorities as agencies continue to update data integrity regulations. The FDA’s ALCOA acronym provides guidance on expectations for pharmaceutical personnel throughout the steps of research and pre-clinical drug discovery and development.
OneSource is designed for full ALCOA compliance, potentially protecting your pharmaceutical firm from FDA warning letters or possible license revocation.
Steps to ensure ALCOA compliance include:
- Implementing username and password requirements that control access and prevent values from being deleted or modified by unauthorized users
- Recording all changes to computerized data
- Making sure raw and source data is available in its original form or as a true copy
- Keeping data in a readable and permanent format throughout its lifecycle
- Configuring backup systems to prevent data loss
- Validating systems through data collection and analysis
Computer System Validation
The purpose of computer system validation (CSV) is to verify that a system, like a lab instrument or software application, produces acceptable information as defined in its perimeters. By proving that a system can withstand scrutiny, it is more likely that the information produced is accurate, consistent, reliable, and human-readable. OneSource provides support for corrective actions in CSV and can perform a full validation for a new system.
Mitigating Common Risks
Despite the many processes in place, risks to regulatory compliance remain. For example, a technically validated instrument that no one has reviewed for validation, or multi-site setups with a variety of procedures across them that could lead to inconsistent data management.
To avoid these and other risks, company culture must cultivate compliance-related responsibilities as well as thorough technical solutions. It’s important for pharma labs to consider if they can perform the necessary activities for data integrity in house or if an outside partner will be more beneficial towards keeping compliance. Outsourcing can provide comprehensive expertise on FDA regulations — and OneSource professional services can assist in streamlining the validation of lab instruments.
For more information on data integrity in a pre-clinical laboratory — and how PerkinElmer’s technical expertise can aid in navigating pre-clinical compliance — click here.