GSC Engineering

Specialists in inter-disciplinary engineering design and troubleshooting

This engineering practice CONNECTS AUTOMATION AND BIOTECHNOLOGY.

Today, if you are doing anything related to biotechnology, then, for better or worse, you are probably using computers. All too often poor automation ruins good science. GSC helps keep that from happening.

Whether you are conducting biotech research, developing a new product, or constructing a new manufacturing plant, computers and/or other automation are almost certainly involved. If the science is not working, then adding a computer, or a fancy graphic user interface, or web interface, won't solve the problem. The wrong technology can create a problem where one didn't exist.

All Problems are "Physics"
Problems may appear as mathematical, mechanical, electrical, thermodynamic, or chemical; ultimately physics is the issue. A robust solution for any requirement or problem requires an architectural design that deals with the physics. Voting on a list of requirements won't make it work.
The automation system must be designed for the problem at hand, because the problem won't adapt to the computer.
Integration into the final environment can't be neglected. New problems arise. No matter how many approval votes or signoffs were done at the factory, nature is casting another vote in the field. GSC first understands the physics of your system, then looks for the automation that will support the system. Sometimes GSC can suggest changes that will facilitate automation or improve reliability.

Why Use a Professional Engineer
Engineers are scientists in clinical practice, trained to make the practical decisions needed to implement a solution now - not necessarily the perfect solution, but a practical solution, and perhaps equally important a timely and cost-effective solution. Licensed Registered Professional Engineers are trained to build solutions that won't come back to haunt you as a liability.

How GSC can help you
GSC can bring to bear experience in construction, hydraulics, pneumatics, mechanics, electric power and controls, electronics/computer manufacturing, fluid power, computer systems, and software products. GSC can help with everything from laboratory automation to plant construction.

Validation
Validation (e.g., GLP, GMP) and code compliance (building, fire, etc.) must be considered - a system must be designed and documented to facilitate validation and to survive an audit or inspection. GSC can help.

Troubleshooting
GSC can apply broad multi-disciplinary domain experience to troubleshooting problems. If a system is broken, or not working optimally, GSC can help.

Nothing seems to cause more confusion, dissension, and anger than these subjects.

Validation is not a substitute for good design, but it is an important part of development and absolutely required for systems subject to government regulation.

In the early stages it is important to show that something can work - if funding is at stake, systems are often shown in the most favorable circumstances.

As production nears, a skeptical attitude is needed - assume a system doesn't work until it is 'proven' (documented evidence demonstrates a high degree of confidence that the system will perform as intended).

Realtors say the three most important things about a house are location, location, and location. The military says they are logistics, logistics, and logistics. Investors say they are management team, management team, and management team. For Validation the three most important things are planning, planning, and planning.

There are many kinds (and names) of plans, tests, and scripts. There is no 'one approach fits all' road to success. Plans must be tailored to the project: custom or off-the-shelf, hardware versus software mix, in-house or purchased, single versus multiple sites, degree of risk, etcetera.

A partial list of possible tests follows. Not every test applies in every case.

Unit Test (UT) - Typically for software; also for hardware components. Tests a single module over a range of conditions, often greater than those expected in practice.

Integration Test (IT) - Typically for software. Tests whether the program works as a whole. Much like an OQ (see below).

Alpha (Systems) Test - A development test of a complete system in the hands of 'users', frequently used to test the logic and/or completeness of requirements.

Beta (Field) Test - An uncontrolled test in the hands of real users. This is also a type of development test.

Installation Qualification (IQ) Test - Ensures the 'parts' are installed correctly. Critical for hardware, people have died from incorrect wiring or plumbing. Commonly applied to network cabling. Increasingly important for software due to interaction between custom, commercial, and system software,

Operational Qualification (OQ) Test - This ensures that the 'parts' work together and the system will operate over the full range of conditions. This is often the basic test of whether software runs.

Performance Qualification (PQ) Test - This ensures the system meets requirements under actual operating conditions. Often this is the same as an 'end-to-end' test.

Testing scripts must be pre-defined for the formal tests: the UT, IT, IQ, OQ, and PQ.
It is important to tailor the tests to the system or project, otherwise you risk expending enormous effort on useless tests that miss a critical weakness. Auditors have a knack for finding these. Nature will find that weakness and cause a failure. If there is litigation, a lawyer will discover it also.

Ideally a system is designed from the beginning to avoid potential problems. GSC can help you achieve this goal.

Validation (e.g., GLP, GMP, 21CFR11) must still be considered. GSC can help you with this.

GSC develops complete system plans, not just software plans.

Connecting biotechnology and automation since 1982