Strict guidelines and high safety standardsThe pharmaceutical industry, as well as other industries such as food and beverage, are subject to strict national and international guidelines. They must comply with the stipulations of regulatory authorities such as the Food and Drug Administration (FDA) or the European Medicines Agency (EMA).
Worst case scenario: The company goes out of business
Companies in the pharmaceutical industry have an obligation to produce supporting documents for all their production processes and sequences. Moreover, they must guarantee compliance with high safety standards at all times. Gaps in the documentation of a production process can result in a loss of license. In some cases, this can mean that decades of research work are completely undone. In the worst case, a company’s very existence can be threatened. Time to market is another significant challenge: Research companies in the pharmaceutical industry must launch their products as quickly as possible because once their patents expire, they’re in competition with generics manufacturers.
Maximum efficiency thanks to integrated plant managementWhen designing a plant, compliance with the stipulations of national and international regulatory authorities e.g. FDA (US Food and Drug Administration) etc. is essential. A plant’s qualification and the validation of product quality must already be integrated in plant engineering, as well as in its later operation. When all parties involved have access to all the relevant information, compliance with all stipulations can be ensured – resulting in a short time to market and optimized patent protection terms.
With COMOS, Siemens delivers a comprehensive software solution that can be globally implemented and that optimally integrates engineering and operation. The COMOS PQM (Project Quality Management) software solution was even expanded to meet the special demands of the pharmaceutic industry. With COMOS, you use a uniform database as a source of information during all phases of your plant’s lifecycle. The solution permits efficient data and document management – consistent, paperless, and mobile.
Always in compliance
Safety and compliance workflows, approval processes, and data mapping are always in compliance thanks to integrated electronic data and document management. This means that they also comply with the standards of the U.S. Food and Drug Administration: They meet the FDA’s “21 CFR-Part 11” requirements (eSign, password). Production and testing procedures for ensuring optimal product quality – including ERES and audit trail regulations – can also be complied with thanks to integrated GMP/GAMP-5 (Good Manufacturing Practice/Good Automated Manufacturing Practice) standards.
COMOS provides integrated compliance management across all phases of engineering and operation and ensures that your plant operates in compliance with regulations at all times. As early as the design and engineering phase, the software generates the necessary document structure based on standardized templates. The uniform database and rigorous object orientation ensure high data quality and consistency, which in turn significantly simplifies compliance management.
The consistency of blueprint and plant as well as material and supplier specifications can all easily be checked with COMOS. The test results of the operational qualification can be simply documented, archived, and retrieved. All processes are optimally mapped, and the seamless documentation guarantees a minimal error rate. Automatically generated maintenance schedules also permit efficient plant supervision.
Internal studies show that we have achieved engineering savings of up to 12% by using COMOS software.Christoph Jauslin, Head of Engineering IT, Novartis Pharma AG, Switzerland
Your benefits at a glance
Keeping an eye on the future: The integrated software solution offers high data security, makes workflows more efficient, and thus ensures higher productivity and quality. The latest electronic certifications are always available, meaning that the software will absolutely guarantee up-to-date certification in the future. Naturally, mobile technologies – an essential element for digitalized companies – can also be used.