White Paper: 3 Ways to Ensure Weighing Data Integrity

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

Solutions to Promote Data Integrity

Data integrity deficiencies often can be traced to human error. But current weighing systems provide a range of features that help ensure process data is accurately captured and securely stored or transferred to the company's data management systems.

Options include:

Printers: Avoid the confusion of messy hand written records by utilizing printed labels and records.
Software: Help to manage data for consistent quality, efficient processes and informed decision making.
Scanners: Manage data completely efficiently and completely hands free with automatic data capture through scanners.

Promote Smooth Audits

Proper data management not only helps ensure product quality and consistency, it also helps to ensure a smooth audit process. Special features such as the 'audit trail' in Freeweigh.Net or Formweigh.Net records all changes to data records, indicating the change itself along with user information and date and time. This ensure compliance with 21 CFR Part 11. Once activated the audit trail cannot be switched off, eliminating the potential for audit trail tamping or loss.

Choosing solutions such that offer such capabilities helps to eliminate the risk of non-compliance during an audit.

Watch the video for an overview then download the white paper!

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.

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.

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.

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.

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.

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.