The reliability and integrity of data are fundamental to regulatory compliance, product quality, and consumer safety. From R&D, and QC to production and logistics, documenting and reconstructing activities is key for instilling confidence in all throughout the value chain. Data volumes growing at an exponential rate pose major challenges in how to efficiently organize and manage across different functions. It is vital for manufacturing companies and entities to securely analyze and share data across functions teams under time pressure with reports that are audit-ready for process review.
Why Is Data Integrity Important?
The Advantages of Digitilization
Automating all or part of data gathering with electronic solutions from METTLER TOLEDO can help ensure your documentation is complete, accurate, and traceable. Digitalization with a data management software helps companies collaborate across their value chains, increase productivity and create new channels to markets.
Digital Solutions for the Laboratory
Laboratory Software
Regulatory compliance software enables faster processes, secure and traceable data ready for audits, and centralized control of all connected instruments to simplify integration into lab IT ecosystem. Læs mere
Data Integrity Resources
Here is a selection of data management tools that help you stay up to date on the latest compliance regulations for achieving data integrity effortlessly. Guides, posters, white papers and more. Læs mere
Automation Systems and Instruments
Processes are more efficient and reliable with lab automation systems and instruments that help lab operators simplify workflows, improve reliability and enhance productivity. Læs mere
Digital Solutions for Manufacturing
Software for Filling
FreeWeigh.NET for Statistical Quality and Process Control is a software solution that allows control and fine-tuning of filling processes to avoid underfilling and comply with data integrity guidelines of 21 CFR Part 11. Læs mere
Connected Weighing in Production
Connected weighing systems and tools help ensure process data is accurately captured and securely transferred to data management systems, supporting Industry 4.0 efforts. The ACI400 Edge offers connectivity to new and existing weighing devices. Læs mere
Data Integrity in Regulated Environments
The ALCOA+ framework is designed to ensure data from equipment used in drug manufacturing is of the highest integrity. Find out about a data integrity system that ensures pharma water systems meet ALCOA+ requirements. Læs mere
Software for Formulation
FormWeigh.NET offers full control with visual displays that guide operators through the recipe process. Capturing weight values automatically & storing them in a central database, speeding up the validation process. Læs mere
Digital Solutions for Packaging
Critical Control Management Software
ProdX™ monitors and manages data collected from METTLER TOLEDO product inspection devices. It securely stores historical data in a central data base protected with highest levels of data redundancy. It supports rigorous quality control regimes and detailed reporting requirements especially in relation to legal metrology and food safety standards where it supplies a trusted proof of compliance. Læs mere
Product Inspection in Packaging
Dynamic checkweighers, metal detectors, x-ray and vision systems provide real-time status and production data to PLC or ERP systems via industrial fieldbus or OPC servers. Læs mere
FAQ – Data Integrity and Digitalization
What is the difference between data integrity and data reliability?
Data integrity is the maintenance and assurance of data accuracy and consistency over its entire life cycle and is a critical aspect to the design, implementation, and usage of any system that stores, processes, or retrieves data. Data integrity is the opposite of data corruption. Data reliability means that data is complete and accurate, and it is a crucial foundation for building data trust across the organization. Ensuring data reliability is one of the main objectives of data integrity initiatives, which are also used to maintain data security, data quality, and regulatory compliance.
Why is regulatory compliance important?
Regulatory compliance is important because it is the communication exchange that demonstrates an organization has met the specified quality standards, such as from Good Manufacturing Practice (GMP) guidelines published by major regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Medicines and Healthcare products Regulatory Agency (MHRA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Using data management software or regulatory compliance software provides additional benefits than simply meeting compliance requirements. It also keeps an organization up to date with the latest regulations and trends, protects the business reputation, and improves efficiency.
What problems can insufficient data integrity cause?
Insufficient data integrity problems can have very costly consequences, such as stopping production or recalling products. In the worst case scenario, medicinal products that haven't followed GMP principles could have fatal consequences. For these reasons, it is worthwhile to invest in solid data integrity solutions throughout the value chain.
What is data traceability?
Data traceability is the process of tracking data as it moves through its lifecycle. This can be done manually or through automated means.
How can data traceability prepare me for audits?
Full traceability records relevant data such as; instrument or device, date, time, method, raw material information and calibration history. All data is available for immediate reporting or direct analysis, resulting in a smooth running audit process. Additional benefits to implementing data traceability are; improved data quality and cost effectiveness, increased efficiency, faster decision making, and enhanced security.
What is data security?
Data security refers to the process of protecting data from unauthorized access and data corruption throughout its lifecycle. Data security includes data encryption, tokenization, and key management practices that protect data across all applications and platforms.
How can I ensure data integrity in my processes?
Ensuring data integrity starts with understanding the basic principles according to GMP guidelines and setting up your process with these principles in mind. A supplier must understand principles such as ALCOA+, data criticality, data risk, and audit trails, so they can adequately support a compliant process. Incorporating automated methods for recording the data in your process, rather than the error prone manual ones, is a first significant step to ensure data integrity in all your processes.
How does automatic data storage in a central database ensure data integrity and data traceability?
Full traceability records relevant data such as; instrument or device, date, time, method, raw material information and calibration history. All data is available for immediate reporting or direct analysis, is stored securely in the database, and can be transferred to the ERP system simplifying archiving of data during the retention period.
What is the difference between digitization and digitalization?
Digitization refers to creating a digital representation of physical objects or attributes. It is when something is transferred into bits or bytes. When a document is scanned, it is then being digitized. Digitalization refers to enabling, adapting, or improving processes by leveraging digital technologies and digitized data with the use of computers, software, and/or internet.
What are the benefits of digitalization?
Many of the benefits companies report from implementing digitalization technologies are; increased efficiency, greater agility and more flexible work methods, improved reliability and security, better collaboration and insights, and significant cost savings.
What is digital transformation?
Digital transformation is a business transformation enabled by digitalization. It is all about leveraging and integrating it in all processes and business areas to enhance engagement and performance while creating new value.
How does data integrity assist digital transformation?
Data integrity facilitates compliance and increases agility and efficiency and is most prominent in the Life Science industries. It enables organizations and companies to collaborate and innovate more efficiently, all while having confidence in their data quality. Reliable, secure, and quality data is the backbone of the digital transformation journey.