Batch Records

Ready to Improve efficiency and ensure regulatory compliance transforming your batch records processes.

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Automated version control of the batch record template reduces the likelihood of using outdated or incorrect procedures.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 increase operational efficiency.

Data Retrieval and Reporting

Searching for specific information within electronic records is faster and more efficient than manually searching through paper documents. This can be especially valuable during regulatory audits and inspections.

Review

Workflow automation enhances standardization and enforces manufacturing processes, enabling exception-based reviews and reducing review efforts by 30% or more.

Equipment Management

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

Featured Contents

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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“Not a day goes by where I don’t reflect on how much easier your system makes this job.”

“We have been audited by FDA twice and they had no concerns about the system nor any findings.”
– Deb Carr, Director, IPD

“The implementation was quite smooth. The team came onsite and worked in parallel with our IT team.”

“Really cool to have data and CofA in the same system. I’ve used other solutions which require access to multiple systems to get the full picture.”
– Radu Mihaila, Director CMC at GBT & Pfizer

“[After sales support is] consistently excellent. They respond quickly, investigate thoroughly, and they can explain everything in a way that we understand and can convey.”

“My experience with the entire team (US & Europe) has been amazing. They are just a phone call away. My work has never suffered because of the lack of the support from their team.”
-Indu Chowdhary, PhD

“In a head to head competition, SciCord was 3x more efficient at documenting a typical work process than [competition]. A complete ‘Assay’ work process required 60 minutes in [competition], while only 20 minutes in SciCord!”

“Very impressed with the Demo. We actually had a call with another vendor just after your demo and they didn’t have half of the capabilities that SciCord was able to show.”

“We can scale our production up to 40% thanks to [SciCord].”

“Other LIMS systems are more challenging to implement”
– Radu Mihaila, Director CMC at GBT & Pfizer

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Batch Records

Balancing Lab Efficiency with IT and Compliance Requirements

Improved Data Accuracy

Real-Time Data Entry and Monitoring

Compliance

Document Control

Data Retrieval and Reporting

Review

Equipment Management

No-code Config

Compliance

Flexible Processes

Flexible Process Definition

Integration

Review

Our Customers

Trusted by organizations of all sizes

What Our Users Say

What Our Users Say

Contact Us

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