ARTICLES BY TIM SANDLE
Are You Approaching LIMS Validation Correctly?4/26/2021
Laboratory information management systems (LIMS) are an established part of larger laboratories. However, different LIMS vary in their scale, functionality, and quality. This article considers the essential validation criteria for LIMS to ensure the system functions as a compliant component in the digital backbone of the modern laboratory.
Complying With Batch Release: Auditing Electronic Batch Records3/26/2021
This article presents some advice for auditing electronic batch records to assess their current good manufacturing practice (cGMP) status. This is useful in the qualification stage and essential once the electronic record system is in operation.
Important cGMP Considerations For Implementing Electronic Batch Records2/26/2021
Mistakes in batch records can have considerable consequences for the release of medicines in terms of delays and rejections. Errors can be minimized through the implementation of electronic batch records. However, with any electronic system within the pharmaceutical industry, the requirements of current good manufacturing practice (cGMP), including those of data integrity, need to be met.
When Biopharma Automation Projects Fail: Averting Disaster1/25/2021
Automation does not always result in success, and poor automation can be as damaging to the pharmaceutical organization as no automation at all. This article addresses what happens when automation goes wrong and how mistakes can be avoided by adopting a risk-centric approach.
Seeing Double: Using Digital Twins To Improve Pharma Processes12/30/2020
The pairing of the virtual and physical worlds not only enables systems to be adapted or repaired from afar, but the approach also further enables the analysis of data and monitoring of systems to avoid problems before they even occur.