Introduction

No-code Config

The SciCord LIMS leverages a unique spreadsheet paradigm, eliminating the need for code in solution configuration. This approach provides an intuitive interface, speeds up implementation, reduces administrative overhead, and seamlessly integrates with your existing spreadsheets used for managing work processes, calculations and reporting requirements.

Compliance

Compliance is at the core of our platform, ensuring adherence to GxP regulations and guidelines. Our platform excels at streamlining the review and approval life cycle, delivering a minimum 30% increase in turnaround efficiency. Furthermore, we offer validated work processes, IQ/OQ packages, and PQ drafting services that effectively accelerates your time to value.

• Defined lists to assure adherence to SOPs.
• Automatic entry verification to flag potential Out-Of-Specification situations.
• Restrictions to avoid use of expired solutions or assure use of equipment by trained individuals.
• Intelligent scans alert reviewers of potential issues with precision, unstable balance, uncalibrated equipment, un-validated process.
• Fully compliant with CFR 21 Part11 including electronic signatures and audit trails.
• Improve your compliance using validated formulas to eliminate calculation errors.

Comprehensive

In addition to a full featured LIMS, SciCord platform includes support features used across the entire Development organization such as LES, MES/EBR, SDMS, and ELN. This comprehensive toolset eliminates the need for multiple niche solutions. SciCord combines the flexibility needed for early development with the structured processes essential for later phase manufacturing and analysis.

Calculations

Calculations & Statistics

The Spreadsheet calculation engine is integral to the SciCord Informatics Platform and formulae are leveraged to perform calculations or statistics.

• The rich Microsoft Excel feature set is leveraged and most Excel functionality is supported.
• Calculations may also be pre-defined, locked, and validated in templates to increase efficiency and compliance.
• Calculations may be defined and performed ad hoc while documenting work.

Connectivity

Instrument Interface

• Instruments with RS232 or IP output are connected and record directly into your experiment.
• Instrument files on file shares or PC hard drives are attached to SciCord experiments for secure storage.
• Printed instrument reports are captured using the SciCord printer driver and stored securely in the SciCord Informatics Platform.
• Custom parsing on attached files extracts data from instrument files and records the data in SciCord experiments for additional calculations, statistical analysis, and/or summarization.

Data Repository

Attach files in the context of your experiment or notebook

• Consolidate instrument raw data and report files and eliminate the use of file shares, local PCs, and hardcopy.
• Copies of your files are created in secure storage with full context and cannot be changed (if updates are required, attach the updated version and the older version(s) will be maintained).
• Attached files of standard types may be viewed directly in SciCord or downloaded to be opened in third party software

Data Mart

Dynamic, customer-specific database tables, which can be customized and optimized according to the user’s needs – without any changes required to the Core application or Templates. Produced data can then be consumed by any generic visualization tool, third data application or external interfaces.

• Query laboratory data using your tool of choice (example: Microsoft Excel®, Microsoft Power BI®, Tibco Spotfire®, SaS JMP®, etc.) to generate Metrics, Protocol Reports, or perform statistical analysis.
• DataMart transforms data into customer specific tables for easy access by scientists.
• Write custom reports against DataMart tables using Microsoft Excel.

Users

Messaging

Workflow is facilitated by a configurable messaging system.

• Messages are automatically generated based on user-defined events or may be initiated manually.
• Messages targeted to individual scientists, reviewers, and approvers are automatically generated at appropriate steps in the sample or document lifecycle.
• The system supports messaging both internally to the solution or via email.

Roles

Roles and Permission

Enforce your organizations policies and compliance commitments using a comprehensive set of configurable SciCord roles and permissions.

• SciCord provides a standard set of roles predefined with permissions to implement pharmaceutical best practices.
• Organizations can configure permissions and create custom roles where needed to implement local practices.

Document Control

Views

Views and Directories

Views and Directories are a powerful tool designed to organize the oftentimes complex world of laboratory documentation.

• SciCord Informatics Platform users create individually customized and persisted desktops to quickly perform daily activities such as “My Documents”, “My Review”, or group documents and samples by project.
• A supervisor may create a team view displaying active work. A project lead could persist a view of work requests for a project.
• Views are used to organize the complex world of laboratory documentation.

Document Workflow

Each Document (experiment/notebook) is subject to a managed/controlled review and approval cycle.

• Workflows are automatically assigned based on the document type.
• The assigned workflow may be upgraded or downgraded at any time in the lifecycle by persons having an appropriate role.
• A document can be completed for a non-compliant purpose and later subjected to a compliant workflow to ensure the work is suitable for regulated purposes.

Samples

Sample Management

Manage internal or external samples with configured sample types to define the different samples across your organization.

• Work requests support assignment of sample related tasks to individuals or groups.
• The sample interface consolidates sample results and provides status at a glance.
• Sample Inventory includes sample requests, transactions, and amounts on hand.

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Sample Lifecycle

Each sample is subject to a managed/controlled review and approval cycle.

• Workflows are automatically assigned based on the sample type.
• The assigned workflow may be upgraded or downgraded at any time in the lifecycle by persons having an appropriate role.
• A sample can be completed for a non-compliant purpose and later subjected to a compliant workflow to ensure the work is suitable for regulated purposes.

Sample Custody

Document transactions involving controlled or toxic substances.

• Inventory transactions such as location change, fill, pick, custody change, and disposal are recorded.
• Transactions can be signed for accountability.
• Sample amounts are automatically reconciled.

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Labels

Customized barcoded labels are generated for samples, standards, solutions, and chemicals.

• Save time using Barcode scanners, which are fast and reliable, rather than manual data entry.
• Labels for any laboratory item may be customized with necessary details and may be printed on a variety of label stocks (sizes/shapes)..

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Review

Visual review interface and links to resources and attachments increases review efficiency by 30% over a typical hardbound notebook review process.

• The review session visually indicates content which requires review and differentiates between initial entries and content which has been modified. An audit history is available to determine what was changed, who made the change, when the change was made and why.
• Proforma information defined in templates including calculations does not require review greatly reducing reviewer effort.
• Links to resources facilitate review of samples, standards, solutions, instrument logs, and materials referenced in the document.
• Joint review is supported where several individual review sections of a document. Each reviewer can visually determine what has/has not been reviewed.
• Multiple review sessions where two or more individuals review the entire document. The effort is coordinated and the document can only be completed when all reviewers have finalized review sessions.
• Calculations are typically verified/validated in templates to eliminate time consuming verification by the reviewer. If calculations are performed ad hoc, the calculation is visually flagged for verification.
• Intelligent Alerts aid reviewers and indicate situations which can require additional scrutiny. Situations such as instruments out of calibration, expired materials, and template not yet verified are listed.
• “Sticky” Notes provide informal communication between the reviewer and scientist. The notes increase efficiency of rework and review.
• A controlled workflow is applied to each document and manages the review and approval cycle.