Matthew Holmes: Electronic Batch Records is one of the most critical features of the Enhanced Quality Solution because it digitizes and automates the creation of batch records, which for regulated industries, is a requirement for demonstrating the proper handling of consumer products. Creating batch records is normally a tedious and error-prone process which involves a lot of manual data entry. In increasingly complex production environments that face short lead times and high SKU proliferation, this burden of proof is often too much to handle without a solution that can auto-populate critical product information into the batch records. Nulogy’s Enhanced Quality solution pulls this information directly from the production environment, providing evidence of safe product handling and helping businesses fulfill one of the most critical requirements under GMP regulation.

 

CP: How does the solution help with safe product handling?

 

MH:  On top of Electronic Batch Records, the solution’s ability to enable digital quality checks and seamless digital sign-offs make it easy for the right person to sign off on critical activities. This effectively ensures that the right product information is received at every touch point, because all of the data flows through one system, and controls the approval and review of regulated events through user identity verification.

 

MH: Several trends including the growth of pharmaceuticals contract packaging. The global pharmaceutical contract packaging market is expected to grow at a CAGR of 14.51% during the period 2017-2021. Also, contract packagers are increasingly concerned around regulatory environment.  According to the Contract Packaging Association’s “State of the Industry Report 2018,” “70% of contract packaging and contract manufacturing companies are concerned that the regulatory environment will have a significant and possible negative impact over the next three years.” Another trend is the continuously evolving regulatory requirements that place more burden of proof on outsourced suppliers. Additionally, SKU proliferation and increased customization to serve hyper-fragmented markets is creating complexity within the production environment and creates more risk, so contract suppliers need to have more control over processes to stay agile in fulfilling the requirements of customers and regulatory bodies. Brand customers are also often looking to drive out costs because of how tight margins are, and expect suppliers to be more efficient and sophisticated in quality control and compliance. 

 

CP: What are some track and trace challenges that customers have expressed, and how will the Enhanced Quality Solution help?

 

MH: Customers find it challenging to work with paper-based batch records or batch record solutions that are separate from their shop floor execution system because of the amount of manual work required to track down records in order to investigate issues, perform root cause analysis, and take corrective action. We designed our Enhanced Quality solution to make it quick and easy to access the audit trail from the electronic batch record and trace back issues. This can be critical in helping our customers get product out the door in time to fulfill orders on-time, in-full, without ever compromising on quality.