Life Sciences

Life Sciences industry broadly includes Medical devices, Pharmaceutical, Bio-Technology and Neutraceuticals. Integrin Enterprise Solutions is working with the industry experts in each of these areas and creating customized business solutions to solve the business challenges in these industries.

Pharmaceutical

Integrin is widely used in Life Sciences industry for supporting key processes and requirements for FDA regulatory compliance requirements including 21 CFR Part 11, Part 210-211, and Part 820 compliance. Pharmaceutical industry often have to deal with the conflicting requirements for complying with regulations from up to a half dozen federal agencies, with the need to maintain security during the development and testing phases. The three biggest challenges facing Pharmaceutical industry include Inventory Management (for both ingredients and products), Production Management/Quality Assurance and Regulatory Compliance.

Batch tracking, for both ingredients and products, is mandated as part of recall management. Fulfillment systems must address the security and shipping labeling aspects. Each lot must be identified and tracked. The ingredients of each batch must be tied to their individual batch number as well. The system should support quality assurance (QA) testing. The protocols should be documented and implemented through the software. The QA system should randomly identify samples for testing and compare test results against norms. Both pharmaceutical ingredients and pharmaceutical products can have limited shelf lives and the system needs to track expired and close-to-end-of-life inventory. Recalls are initiated for two reasons. First, a problem in the process causes a product to become tainted or contaminated. Second, an ingredient is tainted or contaminated. In either case, the system needs to identify all of the affected batches.

Integrin Enterprise Solutions works with the industry experts and created a specialized platform for Pharmaceutical industry, and provides custom workflows and fine grained Traceability. Integrin is very customizable and adapts to the needs of your business and not the other way around.

Life Sciences features,

  • Recall Management using bi-directional traceability
  • Document management e.g. Certification of Analysis
  • Tracking of intermediate or WIP items
  • Tracking of workflow approval & effective dates in history logs
  • Auditing of Batch Manufacturing records, formula changes, workflow approval, inventory from receipt through production