GMP Software for Quality in the Pharmaceutical Industry

The interplay between quality and safety is particularly important in the pharmaceuticals industry, as very often lives rely directly on the products that are developed and produced. That is why this sector is closely monitored by various authorities. It is, for instance, subject to the strict rules of the U. S. Food and Drug Administration (FDA) and underlies directives such as Directive 2001/83/EC of the European Parliament.

These ensure that nothing is brought to market that does not comply with pertinent quality and safety measures and that the product, production process, packaging, and shipping are all faultless. Not only the products themselves are subject to regulation, as the DIN EN ISO 15378 standard, for instance, describes the particular quality management requirements for producers of primary packaging materials for medicinal products. It comes as no surprise, that adherence to quality standards and compliance guidelines are make-or-break factors for any company operating in this sector.

Good Manufacturing Practice

Due to these demands, the companies rely on production practices such as the so-called Good Manufacturing Practice (GMP). This is a set of guidelines that provides guidance for manufacturing, testing, and quality assurance in order to ensure that a manufactured product is safe for human consumption or use. Properly maintaining the associated tools, however, is difficult with pen and paper or spreadsheet solutions alone. This is where CAQ.Net^® comes into play. It facilitates the targeted implementation of individual software modules in order to create a scalable, future-proof, and fully integrated quality management / LIMS system that is validatable in accordance with Good Automated Manufacturing Practice (GAMP) guidelines.

Comprehensive Inspection Data Acquisition

The software consistently supports you throughout all analyses, inspections, and examinations in the laboratory and lays the groundwork for comprehensive sample management. Whether preparing, gathering, and distributing samples or performing statistical analyses and creating control charts: CAQ.Net^® provides you with all the tools you require for data acquisition, preparation, and evaluation in the laboratory. In order to ensure data security and the various traceability requirements, the software also contains tools for batch-tracking and analysis specification. It furthermore supports you throughout the management of deviating analysis results such as Out-of-Specification (OOS) Results, Out-of-Expectation (OOE) Results or Out-of-Trend (OOT) Results.

The integrated certificate generator allows you to automatically generate certificates directly after an inspection has been completed. For this purpose, the software gathers all the batch information of relevant inspections that is contained in the database and generates a tailor-made certificate accordingly. This certificate may also contain individual raw material certificates such as Certificates-of-Analysis (CoA). Additional validation inspections after the laboratory analysis, fully automated label printing or the automatic multi-language creation of batch-related certificates conclude the functionalities of the software.

Total Document Control

An efficient and effective document management system is vital in order to successfully tackle the documentation duties of regulating standards. Create, maintain, control, and archive all your documents with just one program. The document management module can be fully embedded in your existing MS Office environment, allowing you to continue to work with the programs you are familiar with and use CAQ.Net^® to control all document monitoring and maintenance processes in your laboratory and company. Amongst a host of other functions, CAQ.Net^® includes sophisticated escalation management, project tracking, document access control, and facilitates a 100 % paper-free and 21 CFR Part 11-compliant documentation.

Audit-Trail in Place

Aspects such as access control, consistent data monitoring, and FDA-compliant signatures are required in order to ensure compliance and data integrity. The access control used in CAQ.Net^® means that changes made to records, products, or systems are consistently and comprehensively documented in the audit-trail. A separate structure is thereby used in order to record the date/time, username and workstation when changes are made. This allows you to precisely identify, when who made what changes where. Hence, the fulfilment of all relevant documentation duties takes place in the background, and, at the touch of button, you can immediately receive all e.g. audit-relevant change information as stipulated by applicable standards and regulations.

Well-Trained

The training management module supports you during the planning, execution, and documentation of all training-related matters in your company. Apart from assisting during the documentation of all existing qualifications and planning of future employee trainings, it is primarily the consistent target/actual comparison regarding required and available qualifications that provides a significant reduction of the training-related workload. Just a few clicks allow you to fulfil key documentation duties and create an expressive and easily maintainable qualification and training database. The qualification matrix in the software furthermore allows you to, for instance, precisely trace which employee requires training in which area and at what point in time said training is due. This means you can consistently monitor and document any type of training and qualification – regardless of whether you are dealing with safety trainings, language tuitions, technical schoolings, or any other type of training. Powerful e-learning capabilities round off the profile off this module.

Under Control

All change processes in a company must be executed in a controlled manner, as otherwise there is always the risk that important factors are overlooked or inconspicuous details are forgotten. Today’s highly complex production methods and the reliance on various suppliers, however, make it increasingly difficult to maintain an overview of what exactly is affected by the changing of one small part, process, or directive. It therefore comes as no surprise, that applicable standards, rules, regulations, directives, and recommendations stipulate extensive recommendations for the implementation of a comprehensive change-management-system.

The change-control-module in CAQ.Net^® is designed to provide a comprehensive overview of all change processes in your company and ensure that modifications made to products and processes are conducted in a controlled, coordinated, and cost-efficient manner. From the minutest ingredient to the smallest footnote in the product specification sheet or the seemingly unimportant process step at the supplier company: the software ensures that absolutely nothing is forgotten or overlooked and the quality of your products and services is safeguarded throughout even the most far-reaching change processes in your company.

ERP-Integration

CAQ.Net^® is a management system that fluently communicates with other IT-systems and facilitates the mutual transfer of data. Hence, with CAQ.Net^®, the idea of data transparency does not stop at the CAQ-system, as the CAQ-system is also connected directly to the ERP-system. A standard interface transfers master and dynamic data between the two systems. This means that all article master data is synchronized and that incoming goods inspections are automatically logged on in the CAQ-system as soon as new incoming goods are registered by the ERP-system. The direct communication between the two systems thereby greatly increases the overall process efficiency in the company.

Decades of Experience

CAQ AG has over thirty years of experience in the field of computer aided quality assurance and quality management. Our first customers included a variety of manufacturers from throughout the pharmaceuticals industry. Over the decades we have continued to support said customers in the implementation and maintenance of our standard-compliant software solution and many of these customer relationships have since developed into knowledge sharing partnerships. These partnerships allow us to continuously improve our product and rapidly adapt to changing industry demands. The resulting target/actual comparison between CAQ.Net^® and the most current requirements by manufacturers in the pharmaceuticals sector means that our customers are always in command of a cutting-edge software solution that allows professional, efficient, and standard-compliant quality management.

Highlights

• Certified compliance with GMP, ISO 9001, and FDA 21 CFR Part 11
• Bidirectional integration into a vast variety of IT-systems
• Laboratory Information Management System (LIMS)
• Online/offline audit and checklist management
• Certificate generator and management of Certificates-of-Analysis (CoA)
• Qualification matrix for monitoring employee training measures
• Graphic evaluation planning with statistic and analysis functions
• Traceability down to the individual measurement value
• Integrated supplier management and web-based supplier evaluation functions
• Systemwide audit-trail
• Change management with cross-departmental change workflows
• Consistent implementation of PDCA and Kaizen in a cross-modular cycle of control
• Form generator for designing customized forms
• Escalation management for action and due-date tracking
• Workflow-management and assessment of action effectiveness
• Cross-modular linkage of articles, article groups, processes, documents, inspection plans, etc.
• User-specific access control
• Sophisticated system-wide document management functions
• Optimized for usage on touchscreens
• And much more