Datex Pharma EBRS

Pharmaceutical Companies Ensure Quality Assurance and Accuracy Using EBRS
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Electronic Batch Record Software

FDA regulations for the pharmaceutical, biotechnology and life sciences industries mandate that detailed records regarding each batch of product manufactured by pharmaceutical companies be retained.  Batch record data is used in the assessment process to confirm that:

  • Appropriate manufacturing procedures were followed
  • Material inventory was appropriately controlled
  • Workers are identified
  • Training levels are verified
  • Required quality checks were adequately performed
  • Effectiveness of continuing product improvement initiatives and strategies
Bringing together an EBR solution which has been integrated with enterprise information systems helps to associate and synchronize related data.  This helps to enable the seamless flow of information and analysis across product development and manufacturing departments, leading to new insights, action and improved decision making.

Why Should You Use Electronic Batch Record Software?

To ensure the quality and uniformity of the products they manufacture, pharmaceutical companies often utilize electronic batch record software to establish, validate and monitor that each batch is manufactured to the established standards. This aids in:

  • Verifying each business process (vs. standard operating procedure)
  • Facilitating regulatory compliance
  • Maintaining process control
  • Risk management
  • Ensuring data integrity
  • Proper records management
Electronic Batch Record Software (EBRS) enables manufacturers to remove paper records from the production floor and replace the documentation process with a sequenced electronic means of collecting the proper data for  the respective product from the appropriate authority and the proper time.  The electronic batch records can be reviewed in parallel with production.

Benefits of Datex Electronic Batch Records Software

Helps Ensure Regulatory Compliance

  • Automated enforcement of proper CGMP procedures
  • Speeds up identification of data missing from batch records
  • Provides appropriate users access to a single view of the truth
  • Minimizes data entry errors
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  • Limits use to pre-approved supplies & equipment
  • Alerts if non-approved components, equipment or supplies are used
  • Ensures that all collected data values are within approved limits
  • Reduces non-compliance risks
  • Improved batch record accuracy and consistency
  • Prevents use of outdated documents
  • Aids in identification of wrong or expired materials

Track and Trace

  • Provides track & trace by ingredient
  • Saves time and labor on product recalls

Reduces Cost

  • Reduces inventory waste
  • Decreases the incidence of lost batches
  • Reduced operating and labor costs
  • Increases velocity in making product changes and launches
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  • Minimizes investigations, re-work and corrections
  • Enhances labor productivity & reduces administrative burden
  • Produces time & labor savings in data capture, document preparation and QA data review
  • Reduces review time by enabling “review by exception”

Improves Efficiency

  • Decreases product release cycle time
  • Accelerates the overall manufacturing process
  • Eliminates manual signatures
  • Makes worker training level & competency easier to trace
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  • Enables workers to reach to deviations more rapidly
  • Improves decision making
  • Provides enhanced visibility through processes
  • Reduces warehouse inventory

Assuring and Improving Quality of Pharma Products

  • Reduces potential for contamination from dust
  • Reduces possibility of cross-contamination from other batches
Datex EBRS is structured to enable the production sequence to create events that were not-as-expected during the execution of manufacturing.  This provides significant benefit as it allows for a more rapid review of how the sequence was changed after this occurred.  Deviations in the process can then be reviewed and linked to the instigating event more efficiently and accurately.

Using the workflow-driven Datex EBRS enables mandated approval and signatures whenever required.

Electronic batch records can be digitally routed to all required parties and respective users efficiently and effectively, without paper records.  Using a workflow-based EBRS helps to ensure that all procedural steps are followed, reviewed and approved, facilitates compliance of CGMP.

Datex Pharma EBRS Functionality includes:

  • Flexible workflow-based structure to establish and execute master recipes and control recipes
  • Ability to capture all data needed to ensure GMP compliance in master and control (batch) record recipes
  • User configurable recipes for both weigh and dispense and batch management
  • Ability to handle both parallel and sequential processing steps or unit procedures within the same recipe
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  • Step-by-step instructions with built-in controls and verification requirements
  • Data security through use of a secure FDA 21 CFR Part 11 compliant server
  • Ability to restrict access, rights and permissions of users based on role
  • Automated data capture via mobile devices and equipment
  • Automated calculations
  • Creation of work orders for individual tests or process steps
  • Work orders can be sent automatically to managers for assignment and/or approvals
  • Forced authentication and process step sequencing
  • Comprehensive audit trail with employee identification and date/time stamp
  • Real time limit verification
  • Qualification checks on all materials and equipment used
  • Electronic signature capability for person performing the work and a witness
  • Exception reports
  • Non-compliance alerts and flags
  • Tracking by lot
  • Testing of material release states
  • Validation of lot numbers
  • Records deviation at the time of occurrence
  • Testing of material expiration dates

Integration-Ready

Datex Pharma EBRS supports the flow of enterprise-wide data blow and enables bi-directional communication with enterprise IT systems including:

  • Enterprise Resource Planning Systems (ERP)
  • Manufacturing Execution Systems (MES)
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  • Document management systems
  • Laboratory systems
  • Environmental monitoring systems (EMS)
  • Product lifecycle management systems (PLM)
  • Weigh scales
  • DCS
  • Process Control System (PCS)
  • PLC
  • LIMS
  • MMS
  • Supervisory Control and Data Acquisition package (SCADA)
 

All enterprise IT systems must enforce data integrity.  This will ensure that data is taken from the correct place and recorded appropriately.  All workers must follow proper procedures consistently as per the manufacturing instructions for the respective procedure.  To ensure data integrity, data needs to be:

  • Attributable
  • Readable
  • Recorded contemporaneously
  • Either an original or a true copy

What is a Master Batch Record? 

Master Batch Records (MBRs) Also Known as the Master Production Record (MPR)

Master batch record (MBR), also known as the master production record (MPR)includes a thoroughly documented and approved set of directions used to explain how to manufacture a specific product.  Acting as a recipe, the master batch record acts as a standardized template, repeatedly used when manufacturing a specific product.  This helps to ensure product uniformity and quality.

A master batch record includes:

  • Materials and material requirements
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  • Material dispensing setup information with respective instructions
  • Equipment required for production
  • Product name and strength with its description
  • Name and weight or measure of every active ingredient
  • Comprehensive list of components designated by names or codes that is adequately specific to indicate any special quality characteristic.
  • Hazardous classification data
  • Resource requirements
  • An accurate statement which specifies the weight or measurement of each component using the same weight system (metric, avoirdupois or apothecary) for every component.
  • Reasonable variations are permissible in the amount of components needed for preparation in the dosage form, as long as they are justified in the master production and control records
  • A statement which specifies any calculated excess of any component
  • A statement of theoretical weight or measure at the appropriate phases of processing
  • A statement showing theoretical yield. This must include the minimum and maximum percentages of theoretical yield beyond which investigation is required as per 211.192
  • Detailed description of drug product containers, closures and packaging materials. A specimen or copy of each label as well as all other labeling signed and dated by the person or persons who are responsible for approving the labeling
  • A complete set of manufacturing and control directions as well as sampling and testing procedures, specifications, special notations and precautions which are required
    • Workflow events and workflow actions
    • Calculations
    • Data collection
    • Specifications and limits
    • Sampling requirements
    • Notes on batch processing
    • Barcode label printing
    • Electronic signatures
    • All critical information in the product recipe including:
      • Comprehensive specification to manufacture the product in a specific plant
      • Batch size
      • Date range
      • Recipe header information
      • Validity rule data
      • Formula details
      • Routing details
      • Instructions

What are Batch Production Records?

A batch production record is an authentic copy of a master production record, used to document the manufacturing process for a specific batch.  A batch production record (BPR) also known as a batch manufacturing record (BMR) contains the actual data and sequential steps involved in the manufacturing of each batch of product.  A BMR provides the evidence that a batch was manufactured according to standard acceptable protocols and verified by quality control.

Data Reporting and Dashboards

  • Provides standardized reports including:
    • Number and samples of reports completed by each analyst
    • Worker-specific and instrument performance
    • Vendor and materials tracking metrics
    • Procedure compliance: monitors and displays number of unplanned deviations as well as successful processes
    • Reports showing actual consumption
    • Report showing actual production improves recipe management
  • Enables “drag and drop” report creation
  • Dashboards enable quick review
    • Step-by-step compliance flags which identify issues, deviations or notations which require review

Learn more about industry-specific software for your pharmaceutical business: 

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