Empower your data value – with Compliant data and document management

COMOS – Making data work. The pharmaceutical industry and other strictly controlled industries such as food are facing tremendous challenges. In the pharmaceutical industry in particular, a product’s time to market must be extremely short and product quality must be impeccable. Moreover, national and international guidelines formulate concrete specifications for the production and testing procedures. Each individual batch has to be properly documented. A software solution like COMOS provides integrated compliance management.
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Challenges

Strict guidelines and high safety standards

The 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.

Making pharmaceutical plants fit for the future

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Compliant data and document management

Maximum efficiency thanks to integrated plant management

When 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.

Benefits

Integrated compliance management and seamless documentation

COMOS supplies up-to-date information from a single source for plant data and plant documentation. Both process speed and plant safety can be significantly improved with COMOS.

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

Future-proof

Mobile and always with the latest certifications

With COMOS, your pharmaceutical plants are ready for the future today – and securely on the path to Industry 4.0.

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.

References

Compliant data and document management in practice

Solutions for creating data value are already being successfully implemented in the pharmaceutical industry. Discover sample applications that demonstrate how COMOS helps to increase the value of your data in actual practice.
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Empower your data value – with Compliant data and document management

National and international guidelines formulate concrete specifications for the production and testing procedures of pharmaceutical companies. A software solution like COMOS provides integrated compliance management, so that you can always operate your plant in compliance with regulations. Want to talk to our experts? Contact us: