Introduction

Introduction to SciCord Features

No-code Config

SciCord leverages a unique spreadsheet paradigm to provide ELN functionality. This eliminates 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 adhoc 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 SciCord’s 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 PowerBI®, 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.

Cloud Delivery

A cloud-based, SaaS provider featuring customer support and the latest technology to allow for scalability within the lab and organization.

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 internal 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.

ELN Features

Format

Control of content presentation is an important aspect of communicating scientific results and outcome of the work

• Fonts (type, size, underline, italics…), date, time, number of decimals, fill color, wrap, and borders.
• Column & row sizing

Excel Content

Microsoft Excel Content

Insert existing Excel workbooks from your desktop or file share and immediately gain security and audit control as you record information. The Excel content can include pre-defined calculations, charts, data entry validation, lists, conditional format and more, to make data entry efficient, legible, and compliant.

Word Content

Microsoft Word Content

Insert existing Microsoft Word documents from your desktop or file share and immediately gain security and audit control as you record information. Document based proforma can be inserted and then edited with typical word editing format and capabilities.

Images and Shapes

Add visual content, inserting images and shapes to your experiment or notebook.

Sticky Notes

Add informal reminders to your experiment or notebook. The notes may flag information to be added, reminder to complete a task, or communicate a point of interest to reviewer or approver. The sticky notes are removed when the document is completed.

Camera

From a tablet device running SciCord ELN, take pictures to insert directly into your documentation. Example: take a picture of a sample label for verification.

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. The 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.
• Join 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 adhoc, 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.