Regulatory authorities are cracking down on data integrity issues. A recent increase in U.S. Food and Drug Administration warning letters and EU non-compliance reports shows that good documentation practices are often implemented insufficiently or, in some cases, even circumvented.
Download the Data Integrity White Paper to:
- Discover how weighing systems and related software should be selected, installed and configured
- Eliminate documentation errors
- Prevent data tampering and
- Comply with regulations
How can I ensure data integrity in my pharma production process?
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 pharma 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.
What are the most frequent causes for data integrity issues?
The most frequent causes to data integrity issues are; not recording activities contemporaneously, data backtracking, data fabrication (falsification), copying existing data as new data, re-running samples, discarding data, and not being able to produce raw data.
What is the major source of errors for data integrity?
The major source for errors is manual data recordkeeping and transcription, which are more error prone than automated ones. It is easy for workers to mix up numbers, leave out important information or transcribe incorrectly. Lack of training and fatigue can cause these errors to occur more frequently. Also recording production data at a later point of time is a frequent audit finding.
How can I improve the data integrity of my weighing process?
Some options for improving data integrity are; adding a printer, automatically transferring data from scale to PC or using networked software solutions supporting compliance with 21 CFR Part11 or EU Annex 11. Each of these solutions has pros and cons depending on your current process and capabilities. This Data Integrity White Paper covers how these options can easily be incorporated in a weighing process.
How can I comply with 21 CFR part 11 Annex and EU Annex 11 for my weighing process?
When considering true data integrity that complies with 21 CFR part 11 Annex and EU Annex 11, a full integration of weighing equipment into compliant software is desirable. Recipe-weighing or quality-control software, such as Freeweigh.net, offer strong workflow management as well as data capture and reporting. Full traceability records relevant data such as; instrument, date, time, method, raw material information and calibration history. Robust systems also include enhanced user rights management. All data is available for immediate reporting or direct analysis, is stored securely in the database, and can be transferred to the ERP system.
How does automatic data storage in a central database ensure data integrity?
Full traceability records relevant data such as; instrument, 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 symblifying archiving of batch data during the retention periode.