The pharmaceuticals industry is subject to some of the most stringent regulatory requirements. As such you demand compliance with Good Manufacturing Practice from your suppliers. Going hand in hand with these practices is the need for computer system validation of automation and control systems used in product manufacture and delivery. Op-tec Systems utilise GAMP (Good Automated Manufacturing Practice) processes to provide validated computer systems compliant with the US statute requirements of 21 CFR Part 11, related to use of electronic records and signatures for user authentication.
We understand that many pharmaceutical manufacturing processes are complex and therefore rely upon complex systems based on the ANSI/ISA-88 (S88) batch standard. We have strong links with a number of major batch control system vendors with whom we consult in order to provide our customers with the best in class solutions.
As with the chemicals industry, product identification, traceability and serialisation are important factors together with the ever increasing need for process manufacturing information to enable further levels of product development and improvement.
Industry challenges and drivers
The pharmaceuticals industry is highly competitive with a key issue being time to market. The patents manufacturers rely on are only valid for a specific time period, restricting the time available to reclaim research and development, marketing and setup costs.
Since the industry is highly regulated, all critical manufacturing operations, systems and equipment must be documented and validated in detail. This provides an additional expense pharmaceutical companies are keen to reduce, leading to modular solutions (both hardware and software) to benefit from reuseability.
Different approaches to manufacturing in the pharmaceutical industry have been and remain in operation. They range from what can be best argued as empirical methods to the latest evidence based QBD (Quality by Design) and/or PAT (Process Analytical Technology) systems. In truth any of these systems relies on rigorous and proven (validated) processes which in turn demand repeatable and accurate operation of the plant.
Putting you in control
At Op-tec Systems we aim to put our clients "in control". This means:
Comprehensive and accurate documentation, to satisfy regulators and provide you with records of your plant's configuration you can trust.
Working to safety and security best practices, ensuring we exceed the needs of your processes and risk assessments.
Designs based on your needs, not ours. We're truly independent and favour open technology. We'll always leave you with ownership of software we develop on your behalf, and where possible with non-propriatary, future-proof technology.
For the pharmaceuticals industry
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