Life Sciences
Retention of Intellectual Property and Speed to Market
Automation is a key component in verifying quality and speed in the
ever-expanding Life Sciences industry. Flexible packaging, strict batching
standards, validation, operational visualization, secured and detailed data
collection and advanced process control are common in FDA regulated industries,
and a major financial investment for drug manufacturing companies.
A common problem within Life Sciences manufacturing is the need for
standardization, and the Client-wide reuse of validated code, objects,
documentation and the retention of intellectual property. Not only does the
limited reuse of project content lead to a higher engineering investment, the
problem is compounded by extensive re-testing and documentation requirements
associated with validation procedures associated with a company’s GAMP
standards.
The Most Expensive Engineering is Re-Engineering
GGS offers a unique and proven object oriented methodology to help Life
Science manufactures deal with the retention of intellectual property and
engineering re-use. GGS can provide a strategic roadmap and engineering services
for object development, and provide PMP Project Managers to verify the proper
deployment of a global code and documentation database.
Knowledge From Experience
GGS has experience in the development and delivery of systems that must serve
regulatory compliance first but without sacrificing production efficiency. From
the manufacturer of eye solutions to production of filtration media for use in
dialysis processes we have seen a variety of applications in the Life Sciences
industry including:
- Batch
- Sterile Filling
- Vision Inspection
- Quality Management Systems
- Bagging
- Discrete Automation
- Product Assembly
- System Validation and 21 CFR 11 compliance
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