OCR system for simplified equipment calibration

There are large amounts of diverse laboratory and production equipment, and computerized analytical systems used daily in the pharmaceutical industry to ensure that the medicinal products are fit for their intended use. Pharmaceutical companies are conducting procedure validation, equipment calibration, and other routine tests to determine whether the acquired data is reliable.

Procedure validation along with equipment calibration are some essential mechanisms in the pharma business. These demonstrate the accuracy and reliability of the control parameters measured at production premises. Neglecting the named processes would mean reputational risks, legal consequences and major financial losses. Routine inspections provide for seamless production without risks to reputation and investment, as well as the end consumer.

Legislative regulations

Instrument qualification results from discrete activities, which are grouped into four phases:

• Design qualification
• Installation qualification
• Operational qualification
• Performance qualification

And must meet the established requirements:

• GMP Guidelines
  • Basic Requirements for Medicinal Products
  • Basic Requirements for Active Substances used as Starting Materials
• FDA 21 CFR part 211 CGMP for Finished Pharmaceuticals
  • Subchapter C, Drugs: General
    • Subpart D (§ 211.68), Equipment
    • Subpart I (§ 211.160), Laboratory Controls
    • Subpart J, Records and Reports
• FDA 21 CFR part 820 Quality System Regulation: Subchapter H, Medical Devices, Subpart G, Production and Process Controls
• GAMP Good Practice Guide, Calibration Management
• USP General Chapter <1058> Analytical Instrument Qualification

Regulatory background. By Abto Software

One of the key legislative regulations in the United States is the FDA law by the Food & Drug Administration. The current FDA CGMP (Good Manufacturing Practice regulations) require the laboratory apparatus to be properly calibrated at certain predefined intervals in accordance with an established program of scheduled routine procedures (21 CFR 211.68; 21 CFR 211.160).

According to the current FDA CGMP:

• Automatic, mechanical, or/and electronic laboratory equipment shall be routinely calibrated, inspected, or checked according to a written program to assure proper performance
• Instruments, apparatus, gauges, and recording devices not meeting established specifications shall not be used

The other legislative regulations should also be mentioned.

As to GMP regulations:

• The equipment should be calibrated according to the written procedures and an established schedule
• The records should be maintained appropriately
• The current calibrations statuses should be known, up-to-date, and verifiable
• The devices that do not meet calibration criteria should not be used

According to GAMP regulations:

• Calibration documentation has to
  • Be stored in a suitable environment
  • Be retained for an appropriate period of time
• Calibration records have to
  • Include identification of potential, procedures used, tests
  • Contain dates and signatures for the calibration verification

According to USP regulations:

• Calibration and maintenance activities must be properly documented
• Drug manufacturers have to establish practices to address calibration, operation, and maintenance

OCR system to process supportive documentation for facilitated equipment calibration

The problem

Untimely performed process validation together with equipment calibration causes serious business damage. The longer it takes to inspect, identify, service or replace unfit devices, the more financial and human resources are lost.

Another thing, incorrectly performed routine checkups do also come with potential risks to the end consumer. If the used devices are inaccurate, the finished pharmaceutical products might be therapeutically inefficient and harmful.

Since most pharmaceutical manufacturers and distributors are not yet ready to abandon handwritten records, equipment examination as well as calibration comes with traditionally paper-based supportive documentation. And for this reason, the digitization of the control parameters is mostly an intricate, time-consuming process.

What’s more, usually there’s no specially assigned person to perform equipment examination and calibration. This conduces human error, additional workloads, which might also lead to overall employee dissatisfaction, and rather low productivity.

To summarize, handwritten records are the reason for:

• Incorrect and unconsolidated data
• Heavy workloads
• A misunderstanding of the current state of equipment
• Financial losses

That’s why we suggest:

• To stick to the familiar routine and keep handwritten records
• But automate the processes associated with data entry, data processing, and analytics

The solution

Optical Character Recognition technology is the computerized translation of paper-based, written information. This process typically consists of three integral stages – text segmentation, feature extraction and classification.

OCR technology can extract relevant information from records and eliminate the process of manual data entry. It turns handwritten information into accessible electronic documents, which significantly reduces risks, increases accuracy, and provides for improved business efficiency. 

We believe OCR software is beneficial to almost every industry, in particular to the pharmaceutical segment. Computational technology can provide numerous advantages, which include data validity and consolidation, reduced workloads, real-time insights, and profitability.

A custom OCR system can be designed and developed specifically for personal mobile devices and scanners. After routine equipment examination and calibration, the specially assigned technician can scan the records, and the trained platform will transfer the information to the centralized database in a convenient format (e.g. Excel).

The solution can help get a better overview over multiple control parameters:

• Calibration performance of the examined equipment
• Equipment statuses
• Calibration schedule
• Calibration frequency
• Calibration documentation
• Recalibration correspondence 

And be trained to:

• Process documents with different, patchy layouts in one single batch
• Recognize tables
• Process low-quality, hard to read documents
• Process offset, rotated documents

No matter the quality of the incoming documents, the algorithm is able to scan and translate the information. The already scanned and recognized documents are transferred to the central database, where they can be processed, analyzed and grouped for further data management, all without human intervention.

Such optimization can help pharmaceutical companies to comply with industry-specific legislative regulations. And if more generally, computational technology can support the whole pharmaceutical industry to achieve process excellence through superior calibration compliance.

OCR system for equipment calibration. By Abto Software

By implementing OCR technology, pharmaceutical manufacturers get the chance to:

• Access critical, real-time information
• Overview the current statuses of all automatic, mechanical, or/and electronic laboratory equipment
• Receive notifications about potential or already emerged issues 
• Schedule calibration, recalibration, service, and procurement

This way, OCR technology provides for:

• Data validity and consolidation
• Record traceability and accessibility
• Optimized recalibration and maintenance 
• Longer equipment service life
• Thought-out workloads
• Smart allocation of resources
• Reduced risks
• Increased profits

But what is the key point?

Speaking about process optimization, we see great opportunities in implementing immediate notifications. Digital documentation might help set up automatic reminders and notifications to monitor all operations associated with equipment calibration.  

How we can help

Abto Software has the industry-specific knowledge to assist pharmaceutical manufacturers and distributors. Engaging professionals, we help pharma companies in scaling their business.  

Our expertise:

• Data management
• Inventory management
• Drug design & development
• Clinical trials
• Drug track & trace to fight pharmaceutical counterfeiting
• Sanitary control

Contact us to optimize your business and become more competitive!