3 Ways to Ensure Weighing Data Integrity
11Pages

White Paper Weighing Data Integrity 3 Ways to Ensure Compliance Ensuring the reliability and integrity of data generated across the entire pharma production chain is fundamental to regulatory compliance around the world. Also weighing processes – particularly quality critical ones – need to follow those principles. Moving from paper-based systems to hybrid paper-electronic systems or fully automated, networked data-capture can help reduce documentation errors and optimize processes. Weighing – though sometimes oversimplified or neglected – is an important process step in pharmaceutical manufacturing. Dispensing raw materials, dosing material into a tablet coater, checking granulation or tableting all require weighing and documentation for complete, compliant batch records. As such, Good Documentation Principles apply to these activities as stated in relevant Good Manufacturing Practice (GMP) guidelines. Automating all or a part of this data gathering with electronic solutions can help make sure documentation is accurate, traceable and stored safely. In this paper, we will compare manual transcription to documentation with three automated or partially automated solutions, assessing the pros and cons of each. Table of Contents Regulations and Definitions Weighing Data Management Option 1: Adding a Printer Option 2: Automated Data Transfer Option 3: Compliant Networked Solutions Su

Regulations & Definitions Weighing Data Integrity The reliability and integrity of pharmaceutical data is fundamental to regulatory compliance and patient safety. Having confidence in generated data and being able to reconstruct production activities are key. All major regulatory agencies are currently focusing their activities in terms of inspections and publications on the topic of data integrity. Under this close scrutiny, many pharmaceutical companies worldwide have been warned by inspectors because they allegedly falsified or altered data, or because they failed to keep accurate...

Weighing Data Management and Solutions Weighing Data Integrity Manual recordkeeping and transcription is still a popular way of documenting weighing data. It is also one of the major sources of error and other data integrity violations. Mixing up numbers, leaving out important information or not recording values in the proper forms are examples of trouble spots. In severe cases, data is backdated or even fabricated. Not keeping raw data and not documenting routine testing or calibration data are other examples. Frequently observed data integrity issues in pharmaceutical manufacturing: • Not...

Weighing Data Integrity Option 1: Adding a Printer A basic way to reduce transcription errors is to use the print capabilities of your balance or scale. Adding a printer is a simple way to document and store data. An example data flow (Figure 3) at a weighing station used to capture tablet weights after coating might look like this: 1. Results generated by the scale are printed on paper. Some metadata maintained in the instrument can be added. 2. Printed records are then used to manually transcribe figures into reports. 3. Reports are checked for errors by a second person following the "4...

Printing eliminates the error risk inherent when we read and note results off a terminal screen. However, this is still a manually intensive process that requires a significant amount of time and attention. Weighing Data Integrity Pros: Direct printing is a simple way to document and store measurement data without transcription errors. It is cost-effective and easy to implement in existing processes. Cons: Information is not ready for digital processing and analyzing. Manual transcription is still necessary. Printouts also have the tendency to fade over time and can be lost. For critical...

Option 2: Automated Data Transfer Data integrity Checklist An example data flow at a weighing station used to capture container weight before and after granulation might look like this: 1. Results are generated by the scale, then transferredto a computer with the help of data collection software. 2. This data is then transferred to Excel or printed. 3. Reports are double-checked by a second person following the “4 eyes” principle. 4. After that, data may be manually transcribed into an ERP system. Weighing Data Integrity To eliminate manual steps and related transcription errors, a scale or...

Weighing Data Integrity Data Communications Data communication software such as DatabICS or Collect+ allow simple data transfer including some metadata such as value and unit, time and date, material ID, net/gross weight and tare. Layouts are configurable and input masks and calculations are possible. Further measures such as printing reports, checking data accuracy and obtaining signatures need to be implemented via SOPs. System validation is needed if critical data is processed. Pros: Direct transfer from the scale to a computer eliminates manual transcription. Adding simple communication...

Option 3: Compliant Networked Solutions Weighing Data Integrity Data integrity Checklist Recipe-weighing software or quality-control software offer strong workflow management as well as data capture and reporting. These software types provide several significant benefits to data accuracy and integrity over simple data-collection software. For example, at a formulation station where multiple devices are connected and multiple raw materials and recipes are handled, data is highly critical for product quality. Similarly when looking at quality control processes to monitor fill levels or tablet...

When considering true data integrity in regulated environments, full integration of weighing equipment into compliant software is highly desirable. Weighing Data Integrity Pros: Data is automatically transferred to eliminate transcription errors and increase productivity. Processes and calculations are guided to ensure each user carries out the same procedures, helping to eliminate rework and waste. Metadata is linked to results, supporting full traceability. A variety of import or export options allow data transfer into existing networks, data archives or ERP systems. Cons: Complete...