Data integrity is critical to meet current good manufacturing practices and ensure patient safety. In quality control (QC) labs, data is scrutinized during audits as it supports the quality, safety, and efficacy of a product and indicates a facility’s state of control.
Most QC labs have been working on the fundamentals of data integrity and have made progress in areas such as digitization and compliance – but there are many challenges ahead.
Systems and business practices have evolved, expectations for efficient investigations have risen, and there is a desire to improve knowledge and insights through better access to data. The next steps in data integrity are key to the QC lab of the future and the digital maturity of the manufacturing capabilities.
This environment means industry must be clear on where to focus its energies – this is why BioPhorum’s latest paper targets the most important challenges and presents a problem statement, good practices, and desired future state for each.
Tackling the challenges
Data integrity challenges in the quality control labs identifies five crucial challenges – legacy systems, integrated lab systems, contract labs, cloud systems, and next-generation sequencing in the GxP environment.
It supplements the well-known existing guidance on data integrity but, by detailing these five challenges, it focuses on areas that have had less attention. It also explores issues beyond the basic elements of complying with data integrity guidelines.
The paper will help when you are designing, implementing, and reviewing data integrity actions for your new implementations and upgrades – but it will be especially useful if your projects involve legacy instruments, multiple organizations, or cloud solutions. We also suggest that you review these challenges during your regular data integrity risk reviews.
It uses common problem definitions so that standard solutions can be mandated by biomanufacturers and implemented by vendors – this will allow investment to be focused and lead to greater robustness across industry. The paper will also educate practitioners and decision-makers on current industry good practices, equipping them to push for progress and leveling up.
The BioPhorum paper will create the vision to help you move to an improved future state by suggesting practical and concrete solutions. It will be a valuable resource when developing your data integrity plans and asking for investment. With its help, advocates for change can envision and persuade other stakeholders to raise their game by showing the opportunities for significant business benefits.
Tackling these challenges will require partnerships between instrument and software vendors, service providers, and contract and sponsor organizations – and this is where BioPhorum will bring its collaborative skills to the fore.