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Batch Records


Improve efficiency and ensure regulatory compliance by transforming your batch records processes. Convert your existing spreadsheets or written SOPs into validated, repeatable batch records quickly.

Balancing Lab Efficiency with IT and Compliance Requirements

Many development organizations are struggling to maintain productivity and compliance with legacy paper or spreadsheet-based batch records processes. These organizations realize the solution is an electronic batch records system but see significant migration risk. SciCord utilizes no-code configuration, which minimizes your risk and expedites your implementation to swiftly capture electronic batch records benefits.

Improved Data Accuracy

Reduce the risk of manual data entry errors, which are common in paper-based records. Ensure critical manufacturing data, such as ingredient quantities and process parameters, are accurate and consistent.

Real Time Data Entry and Monitoring

Enable real-time data entry and monitoring of the manufacture process. Immediately detect deviations or out-of-spec conditions, to quickly correct issues and improve product quality.

Compliance

Electronic record and signature capabilities meet regulatory requirements, such as FDA’s 21 CFR Part 11. Detailed audit trails provide a complete history of all actions and are valuable for regulatory reviews and investigations.

Document Control

Automated version control of the batch record template reduces the likelihood of using outdated or incorrect procedures. Workflow automation (review and approvals) applied to a batch record increases operational efficiency.

Equipment Management

Calibration and maintenance event scheduling and tracking assure compliance. Equipment references in Batch Records minimize transcriptions and support utilization reporting.

Data Review, Retrieval, and Reporting

Workflow automation enforces manufacturing processes, enabling exception-based reviews and reducing review efforts by 30% or more. Searching for specific information within electronic records is faster than paper, especially valuable during regulatory audits and inspections.

No-code Config

A key differentiator is SciCord’s embrace of spreadsheet technology to easily migrate your existing paper or spreadsheet-based batch records into digital media. Spreadsheet flexibility, functionality, and compatibility with scientific data and processes make them a natural fit in scientific organizations. Configurations in SciCord leverage the extensive user interface capabilities of spreadsheets integrated within a secure, compliant, and connected information platform. The no-code configuration steps below can be executed by your scientists familiar with spreadsheet design and operation or relying on technical expertise provided by SciCord engineers.
Step 1: Lay out your batch record process utilizing the rich spreadsheet toolset: extensive formats, data validation, lists, calculations, charting, images, and process flow design elements. Existing batch record spreadsheets can inform the design and further accelerate implementation.
Step 2: Integrate your batch record with LIMS and ELN functions: sample management, inventory, equipment, electronic signatures, instrument interface, workflows, file & data management, and reporting. Step 3: Test/validate your electronic batch record taking advantage of SciCord’s IQ, OQ, and PQ methodology.

ELN samples can be used to print a label for the physical sample, which can be scanned to retrieve its ELN record.

Compliance

Electronic batch records improve GxP compliance:
  • Eliminate potential audit findings with structured comprehensive documentation
  • Equipment cleaning/maintenance scheduling and completion records
  • Comprehensive audit history to log all user actions and electronic signatures to attribute workflow decisions.
  • Automated labeling of products and samples

Flexible Process Definition

Configurable Electronic Batch Records can be used to securely record:
  • Manufacturing information: Description, Date, Site, Operators, Lots
  • Bill of Materials
  • Equipment lists and checks/maintenance records
  • Instructions for Manufacturing
  • In-Process or Retained Sampling

Integration

Batch records benefit from tight integration with LIMS components:
  • Training Records: Verify operators have required training to perform batch operations.
  • Equipment Logbooks: Assure equipment is calibrated and cleaned.
  • Material Inventory: Confirm bill of materials contains only approved, unexpired materials.
  • Scheduling for rooms, equipment, people, and testing.

Review

The overall quality of data and efficiency of the review and approval process can be dramatically enhanced by SciCord’s electronic batch record. The effort required for reviews is decreased by 30%.
  • All information is accessible electronically, avoiding delays tracking down notebooks, instrument records, or data files in cabinets or on file shares
  • Templated batch record processes include validated calculations and data validation to avoid time consuming verifications.
  • Review by exception creates an efficient review process with exception trends, reduced batch record review time and paper elimination.
  • Good documentation practices are enforced. All entries are stamped with analyst name and date recorded. Changes to data are fully documented with reason for the change. Calibration and expiration dates are documented at the time of use.
  • Communication during the review process is optimized by electronic sticky notes to facilitate a conversation between reviewer and analyst.
  • Electronic signatures and sign off by analyst, reviewer, and approver avoid delays transmitting documents between staff.

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This is by far the best value in science software (or anything else in science, really) that we’ve ever experienced. Other solutions in this price range had a fraction of the features, and those with the features cost 3x – 10x more. We’re very happy customers.

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