Overview of SciCord Capabilities

SciCord is a next-generation laboratory information management system (LIMS) designed to streamline data management, enhance compliance, and improve overall lab efficiency. Unlike traditional LIMS, SciCord integrates native spreadsheet functionality with a no-code platform, providing a flexible and user-friendly solution tailored to modern laboratory workflows.
Key capabilities of SciCord include:

• Native Spreadsheet Integration: Combines the familiarity of spreadsheets with robust LIMS functionalities.
• No-Code Configurability: Enables users to tailor workflows without programming expertise.
• Regulatory Compliance: Supports audit trails, electronic signatures, and data integrity.
• Seamless Collaboration: Allows teams to work efficiently across departments.
• Scalability: Adapts to the needs of small research labs and large enterprise operations.

Native Spreadsheets vs Traditional LIMS

Traditional LIMS often require rigid, structured data entry and complex configurations, making them challenging for dynamic laboratory environments. SciCord’s native spreadsheet approach offers a more intuitive and adaptable alternative.
Advantages of Native Spreadsheets:

• User Familiarity: Scientists and lab personnel can leverage existing spreadsheet skills without extensive training.
• Flexibility: Unlike traditional LIMS that impose strict data entry forms, native spreadsheets allow for easy customization and real-time calculations.
• Rapid Implementation: Reduces the time and cost associated with setting up and configuring a traditional LIMS.

In contrast, traditional LIMS solutions can be cumbersome, requiring IT intervention for modifications and updates. SciCord’s spreadsheet-centric model bridges the gap between structured data management and ease of use.

Benefits of No-Code Configurability

SciCord’s no-code configurability empowers laboratories to modify workflows, data structures, and reporting templates without relying on software developers.

Key Benefits:

• Customization Without Coding: Labs can create and adjust workflows based on evolving needs without technical expertise.
• Increased Agility: Enables rapid adaptation to new research projects, regulatory requirements, and operational changes.
• Cost Efficiency: Reduces dependency on external IT resources, lowering maintenance and support costs.
• Enhanced Productivity: Scientists and lab managers can focus on research rather than software constraints.

By combining native spreadsheets with no-code configurability, SciCord delivers a powerful, flexible, and user-friendly alternative to traditional LIMS, revolutionizing the way laboratories manage and analyze data.

SciCord stands at the forefront of laboratory informatics by offering an innovative approach that merges the power of native spreadsheets with no-code configurability. This unique combination allows laboratories to streamline workflows, enhance compliance, and improve overall efficiency while maintaining the flexibility needed to adapt to evolving scientific and regulatory demands. By reducing reliance on IT and empowering lab personnel with intuitive tools, SciCord paves the way for a more efficient, cost-effective, and data-driven future in laboratory management.

A Decade of Innovation in Digital Lab Transformation, now validated.

We’re thrilled to share that SciCord has been included in two 2025 Gartner Market Guide reports for both Laboratory Information Management Systems (LIMS) and Electronic Laboratory Notebooks (ELN) categories.

This marks our second recognition in the ELN category — and, for the first time, we’ve also been named in the LIMS category. We believe it’s a meaningful milestone for our team, our customers, and the broader scientific community we support.

Being named a Representative Vendor in both categories reflects SciCord’s strong alignment with industry needs and continued contribution to its evolution.

A Platform Built for the Digital Lab of the Future

At SciCord, we’ve spent the last decade building a unified, cloud-native platform that brings ELN and LIMS functionality together — not as disconnected modules, but as a seamlessly integrated system purpose-built for regulated pharmaceutical and biopharmaceutical environments.

We believe scientists shouldn’t have to choose between usability, compliance, and scalability. With SciCord, they don’t.

What the Gartner Market Guides Emphasize — and How SciCord Delivers

At SciCord, we’re proud to deliver on these expectations. Below are just a few examples of how our platform addresses the critical capabilities Gartner highlights — among many others that continue to drive value for our customers every day.

Fast Time-to-Value

Gartner highlights the importance of platforms that enable rapid digital transformation:
“This shift is essential to enable high-performing digital lab strategies requiring access to AI capabilities, made possible by advancements in both programming and platforming, particularly API management and low-code programming.”
With no-code configuration and an interface scientists already understand — the spreadsheet paradigm — SciCord can deliver validated solutions in weeks, not months.

Efficiency Through Automation

Lab efficiency isn’t just a nice-to-have. It’s a competitive advantage.
“Workflow management: Automates laboratory workflows, including sample processing, testing and reporting. This helps to reduce errors and increase efficiency.”
SciCord automates lab workflows, approvals, and reporting — delivering 30%+ gains in operational efficiency for most customers.

Compliance by Design

In highly regulated environments, right-first-time data entry isn’t optional — it’s essential. As highlighted by Gartner, “Validation and regulatory compliance: Provides a method and module for ensuring the quality, accuracy, and compliance of laboratory operations. For instance, the pharmaceutical industry requires GxP compliance in manufacturing and 21 CFR Part 11 compliance in research, but also regulator access to systems and report generation.”
SciCord is built from the ground up for GxP and 21 CFR Part 11. Features like real-time audit trails, role-based permissions, and e-signatures ensure your lab stays compliant without slowing you down.

Scalable SaaS with Minimal IT Burden

Modern labs need to scale and adapt without the overhead of custom infrastructure.
“Cloud-hosted and SaaS offerings […] are dominant for new or modernized deployments.”
SciCord’s cloud-native architecture eliminates the need for heavy IT support, reduces technical debt, and grows with your organization.

Helping Customers Accelerate What Matters

Our customers span global pharma leaders, growing biotechs, and everything in between. What unites them is the need to move fast — while staying compliant and keep costs in control.

By digitizing and unifying laboratory operations, SciCord enables:
– Faster submissions and drug approvals
– Improved collaboration across global teams
– Standardized processes with full traceability
– Streamlined data integrity and audit readiness
– A lower total cost of ownership with measurable ROI

Looking Ahead

To us, Gartner’s recognition validates the work we’ve done, but more importantly, it inspires us to keep pushing forward. As the demands on R&D labs evolve — from AI integration to increased regulatory scrutiny — SciCord will continue to lead with innovation, agility, and an unwavering focus on scientific outcomes.

Whether you’re replacing legacy LIMS and ELN systems or starting your digital journey, SciCord offers a future-ready path that’s built to scale, built to comply, and built for scientists.

Ready to Transform Your Lab?

 

---

Gartner, Market Guide for Laboratory Information Management Systems, 16 April 2025
Gartner, Market Guide for Electronic Laboratory Notebooks, 5 May 2025

Gartner does not endorse any vendor, product or service depicted in its research publications, and does not advise technology users to select only those vendors with the highest ratings or other designation. Gartner research publications consist of the opinions of Gartner’s research organization and should not be construed as statements of fact. Gartner disclaims all warranties, expressed or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose.
GARTNER is a registered trademark and service mark of Gartner, Inc. and/or its affiliates in the U.S. and internationally and is used herein with permission. All rights reserved.

Ensuring Compliance in the Digital Age

Data integrity is a critical component of regulated industries, particularly in pharmaceutical and biotechnology sectors, where precise and accurate record-keeping is essential. Organizations must comply with stringent regulatory frameworks, such as FDA’s 21 CFR Part 11 and EU Annex 11, which mandate secure and traceable data management practices. Failure to uphold data integrity can result in regulatory penalties, product recalls, and compromised patient safety.

Laboratory Information Management Systems (LIMS) and Electronic Laboratory Notebooks (ELN) play a crucial role in safeguarding data integrity by providing automated, secure, and transparent solutions for data capture and management. This article explores the key tools within LIMS and ELN platforms that ensure compliance and improve data reliability.

---

Key LIMS and ELN Tools for Compliance

Automated and clear Audit Trails

Audit trails are essential for tracking changes, ensuring accountability, and preventing unauthorized modifications. LIMS and ELN systems maintain a complete, timestamped record of data modifications, detailing who made changes, when they were made, and the reason behind them. This feature is vital for compliance with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) regulations.

Secure Electronic Signatures and Access Controls

Regulatory guidelines require that electronic records be protected from unauthorized access or alteration. LIMS and ELN platforms implement secure user authentication mechanisms, including multi-factor authentication (MFA) and role-based access controls (RBAC). These security measures ensure that only authorized personnel can access or modify data, thereby reducing the risk of data breaches and ensuring compliance with industry standards.

Data Validation and Standardization

To maintain consistency and accuracy, LIMS and ELN platforms integrate built-in validation rules that prevent data entry errors. These tools ensure adherence to standard operating procedures (SOPs) and enable real-time data validation, reducing discrepancies and improving data quality.

---

Case Study: Pearl Therapeutics’ Regulatory Triumph

In 2015, Pearl Therapeutics, later acquired by AstraZeneca, embarked on developing innovative inhaled formulations. Facing resource constraints, the company prioritized enhancing laboratory throughput and implementing data trending and visualizations to inform development strategies. They adopted the SciCord Informatics Platform, integrating LIMS and ELN functionalities, to streamline their data management processes.

Challenges Addressed:

• Complex Formulation Variables: Managing multiple physical constituents in metered dose inhalers required extensive characterization through numerous formulation batches and stability trials.
• Intricate Sample Preparation: Ensuring unbiased test results necessitated meticulous sample preparation and analysis.
• Advanced Data Analysis: Simulating lung function involved complex calculations, requiring seamless data transcription from instrument reports to specialized software.
• Data Trending and Visualization: The need for robust data trending and visualization capabilities to understand formulation and stability impacts.

Impact of LIMS and ELN Implementation:

• Efficiency Improvement: The review process saw a remarkable efficiency improvement of over 30%.
• Enhanced Data Management: Structured data and custom reports enabled robust trending and visualization capabilities.
• Streamlined Operations: Validated solution integration across all operational functions facilitated efficient management across multiple sites.

This case study underscores the transformative impact of implementing LIMS and ELN platforms in enhancing data integrity and compliance. (Read more)

---

The Future of Data Management in Regulated Industries

As technology evolves, new advancements in data management are shaping the future of compliance and data integrity. Artificial intelligence (AI) and machine learning (ML) are increasingly being integrated into LIMS and ELN platforms to enable predictive analytics, anomaly detection, and automated data classification. These innovations help organizations proactively identify compliance risks and enhance data-driven decision-making.

Moreover, the adoption of blockchain technology is gaining traction for secure and tamper-proof record-keeping. Blockchain’s immutable ledger system ensures that laboratory data remains unaltered and fully traceable, adding an additional layer of security to digital records.

---

Strengthening Compliance with SciCord’s LIMS and ELN Solutions

Maintaining data integrity is not just about regulatory compliance, it’s about ensuring scientific reliability, product quality, and patient safety. By adopting advanced LIMS and ELN platforms, organizations can enhance data accuracy, reduce compliance risks, and improve operational efficiency.
Ready to improve your data integrity and compliance? Explore SciCord’s LIMS and ELN solutions today!

Challenges of Finding and Implementing an ELN and LIMS

The best solution for a company transitioning from paper to an electronic system is to select a hybrid ELN plus LIMS solution. The ELN and LIMS components in a hybrid solution are integrated by a single vendor and should provide optimum transparent communication. Most organizations do not implement hybrid solutions for a few reasons:

1) Hybrid solutions combining best of class ELN/LIMS are rare.

2) The desirability of deploying both ELN & LIMS is not initially understood.

Typically, when confronted with phase III compliance challenges, organizations choose to deploy a LIMS. Although excellent at organizing samples and results, LIMS does very little to reduce compliance/data volume issues at the bench. To address these issues. ELN functionality is required.

SciCord Drives a More Efficient Lab

The SciCord Informatics Platform provides a comprehensive, quick-to-implement, compliant solution – including LIMS and ELN functionality – to minimize costs, improve productivity, and reduce IT footprint.

The table below illustrates an optimum distribution of functionality. The allocation attempts to create a contiguous workflow and utilize the strengths of each solution.

 

Combining the Benefits

The strength of an ELN solution is the ability to easily document laboratory work. In addition, ELN solutions facilitate co-working and sharing of documentation between colleagues. Most ELN solutions do not support definition of Samples, Analyses, and Structured Results which are required for later stages of development. Work flows (document and sample review & approval cycles) are largely absent from ELN offerings as is adherence to GMP compliance regulations. By and large, an ELN is relegated to very early development or must be paired with a LIMS to effectively support later pharmaceutical development stages.

The strength of a LIMS is management. Samples, Users, Instruments, Resources (solutions, standards), Structured Data, and Application Integration are all managed effectively by LIMS. LIMS software is at the center of an information web with the ability to process and report data as required by later drug development stages. The very structured nature of LIMS however hampers the ability to effectively capture lab data at the bench. Implementation and maintenance of a LIMS is also difficult for smaller companies without dedicated IT resources.

Summary

SciCord’s Platform is provided as COTS (Commercial Off-The-Shelf) software. SciCord provides a complete package documenting control of the software product. Additionally, documentation and testing are required to verify the software product meets the organization requirements within the target environment with appropriate control of people, hardware, and process. SciCord’s pharmaceutical validation Service is intended to provide the required customer specific documentation.

Goal

Computer system validation of a COTS solution in the pharmaceutical industry must ensure an acceptable degree of documented evidence establishing confidence in the consistency, accuracy, and reliability against predetermined specifications.

The SciCord Validation Service goal is to ensure both technical and procedural controls are implemented for compliance with good documentation practices for electronic data generated by the system

For COTS solutions, much of the documentation/testing in the model above should be supplied by the vendor. The customer specific documentation includes User Requirements and Performance Qualification.

Deliverables

Document Description	Document Strategy
Validation Master Plan	Establishes the objectives, policy, resources, execution and management of the SciCord ELN validation effort.
User Requirements Specification for SciCord ELN	User requirements defined in collaboration with Customer including review of Customer SOPs and work practices
Standard Operating Procedures	Procedures for SciCord ELN Administration & SciCord ELN Use are written in collaboration with customer.
Training	Training is provided to customer lead users.
Functional Specification for SciCord ELN	SciCord Requirements Document and description of additional functional to be provided via configuration, templates, or reports.
Design Qualification for SciCord ELN	Comparison of SciCord Functional Requirements to User Requirements Specification. Verifies that the proposed design and configuration of the system is suitable for its intended purpose.
Installation Qualification	SciCord Production Environment IQ
Operational Qualification	SciCord Test Plan and Summary Report.
Risk Assessment	Identify risks associated with Customer deployment that will be mitigated procedurally or with PQ testing.
Vendor Audit	Optional: Third party or customer Quality Assurance audit (1 day) at customer expense.
Performance Qualification	Utilize the output of the risk assessment to design and execute test cases intended to verify system functionality as configured for use.
Validation Summary Report	Validation report that provides an overview of activities. This report to also include a summary of associated validation documents, define the configuration of permissions associated with system roles, and provide a traceability matrix between requirements and associated testing.
System Release	Document to be provided to Customer Quality Assurance to release SciCord ELN for production use.

Enhancing Lab Efficiency: A Comprehensive Informatics Platform

Mr. Naughton’s comments are insightful, primarily because he works in the biotech industry and acknowledges the vital role a LIMS (Laboratory Information Management System) plays. Even in the pharma and biotech industries, people are confused about the differences between an ELN (Electronic Lab Notebook) and a LIMS.

SciCord works to bring LIMS and ELN, and other common lab software, together into one informatics platform. Our customers see at least a 30% efficiency improvement. These improvements are delivered through a secure cloud infrastructure that allows all your data to be accessible across your organization.

 Why Software as a Service?

SaaS minimizes your total cost of ownership. Maintenance and backups are included, minimizing IT overhead.
SciCord provisions required hardware, eliminating initial hardware purchase and refreshes.

Security

Award winning Azure cloud platform meets a broad set of international and industry-specific compliance standards, such as General Data Protection Regulation (GDPR), ISO 27001, HIPAA, FedRAMP, SOC 1 and SOC 2. Data is encryption at rest and in transit.

Backups and Replicates

Backups are made to two physical locations, Incremental Daily, Full Weekly, Full Monthly. Completed document bundles are provided to you for your own on-site storage.

 Why Software as a Service?

SaaS also allows SciCord to utilize a more robust central cloud infrastructure, based on Microsoft Azure. The SaaS provider manages the application, provides hardware, maintains security, and routinely monitors performance. By contrast, a local-only implementation requires hardware to be managed on-site, dedicated staff to be assigned to maintain it, and increases the risk of data loss in the event of unforeseen accidents or hardware failures.

Implementing SciCord as a SaaS product also allows for quicker and smoother implementations. Typical benefits or advantages of a SaaS solution include:

1. Reduced time to benefit
2. Lower costs
3. Scalability and integration
4. New releases (upgrades)
5. Easy to use and perform proof-of-concepts

 Azure

SciCord utilizes the Azure server network, making SciCord Informatics Platform accessible around the globe.

 ELN or LIMS?

SciCord’s SaaS approach also facilitates delivering multiple software solutions in one package. Laboratory Information Management Systems (LIMS) and Electronic Notebook (ELN) are key parts of this feature set.

• LIMS is focused on the management and tracking of laboratory samples, workflows, and associated data. Read more about us from a LIMS perspective here.
• ELNs are primarily designed to replace traditional paper laboratory notebooks. Read more about us from an ELN perspective here.

SciCord also includes features of document management (SDMS), batch record (EBR) or Manufacturing Execution System (MES), and Lab Execution (LES) systems.

SciCord excels in Pharma labs, manufacturing, R&D, and biotech by:

Delivering Our Service Effectively

SciCord serves both GxP and non-GxP clients. SciCord provides the software and the infrastructure, maintenance, and support.

Protecting Data from External Threats

All SciCord systems are periodically updated with the current patches and security protocols. Data in the SciCord database is encrypted to protect it. Data is also encrypted when transmitted between a client’s site and the Cloud servers. Additionally, clients can expect external protection tests at least annually, with every major software release.

Protecting Data from Improper Internal Access and Vulnerability

A layered password system allows users to access only the information and resources required to perform their legitimate tasks. As designated by FDA 21 CFR part 11, SciCord incorporates security features such as timestamps and digital signatures to assure regulated agencies that data on the system is consistent, not tampered with, and in general follows the data integrity directives mandated by the FDA. The system is also evaluated at least annually to verify its effectiveness.

Additionally, SciCord safeguards application and interface security by:

• Following SDLC (Software Development Life Cycle) guidelines, which outline phases of development, each with built-in control features.
• Using only in-house code developers.
• Penetration testing for each major version
• Regularly testing the software against OWASP Top 10 to identify any vulnerabilities.

Instrument Access

SciCord accommodates real-time data collection and displays from balances, pH meters, and other instruments by monitoring an IP address. For instruments that feature a result database, SciCord connects to the database, acquires the results, and records them. For all others, a printed output or created spreadsheet/CSV can be parsed for data import.

User Guidance

A lab doesn’t need to overflow with IT gurus or ‘superusers’ to reap the benefits SciCord provides. Users only need PCs that run Windows and basic working knowledge of spreadsheet software. SciCord provides initial instruction and training as well as periodic support.

SciCord offers the support required to implement and customize the software to fit a client’s needs. Each client is assigned a Project Manager to coordinate the deliverables between each lab’s personnel and the SciCord personnel.

Objective

Outline the requirements and strategies for creating a compliant Excel workbook.

Why Validate?

Spreadsheet software is a powerful tool for processing data. This allows it to be an extremely useful asset for the pharmaceutical industry, however, it can also be a huge risk. Each year citations from regulatory bodies inspecting pharmaceutical labs are given out to companies for their use of un-validated spreadsheets. While almost all professionals in the industry have some degree of experience with spreadsheet software, the level of technical ability varies greatly from user to user. Excel spreadsheet validation creates a standard that is acceptable for all associates involved in the project.

When to Validate?

In a Q&A issued by European Medicines Agency: “Validation according to paragraph 4 of annex 11 is required at least for spreadsheets that contain custom code (e.g. Visual Basic for applications). Formulas or other types of algorithm should be verified for correctness. Therefore, appropriate controls for templates of spreadsheets must be in place. Erroneous calculations due to data remaining from previous calculations must be avoided. The templates should also be suitably checked for accuracy and reliability (annex 11 p7.1) and should be stored in a manner which ensures appropriate version control (chapter 4 p4.1).”

Common Issues with Spreadsheets

There are many hurdles to making spreadsheets compliant. The following are just a few of the common issues that must be addressed.

• Easy access to programs
• Everybody (not trained on GxP compliance validation and computer science) can write programs
• Everybody can change without control
• No validation, no documentation
• Many different environments (operating systems, PC hardware)
• Many versions in use (local PC, server, inbox, delete folders)
• No or insufficient documentation

Procedures

Successful validation is dependent on proper planning and procedures being in place. It is likely that a large number of spreadsheets will be involved and therefore efficiency and repeatability are critical factors in the validation process; the key to efficiency and minimizing the validation costs is to keep the process simple. This is achieved by introducing streamlined processes throughout the validation lifecycle and the use of a generic, yet adaptable, set of documentation. This includes validation SOPs, usage SOPs, and Validation Plans.

Design

The spreadsheet should be designed with compliance in mind following established documented procedures. However, it is common that a spreadsheet has already been created and is in use before the decision to validate is made. The FDA has issued the following requirements as a guide to validating spreadsheets:

• Lock all cells of a spreadsheet, except those needed by the user to input data.
• Make spreadsheets read-only, with password protection, so that only authorized users can alter the spreadsheet.
• Design the spreadsheet so that data outside acceptable conditions is rejected (for example, reject non-numerical inputs).

Validating

Each company has different approaches to Excel spreadsheet validation. Regardless the method (Validation Plan vs. SOP), the following points must be addressed at minimum:

• Manually verify spreadsheet calculations by entering data at extreme values, as well as at expected values, to assess the ruggedness of the spreadsheet.
• Test the spreadsheet by entering non-sensical data (for example alphabetical inputs, <CTRL> sequences, etc.).
• Keep a permanent record of all cell formulas when the spreadsheet has been developed. Document all changes made to the spreadsheet and control using a system of version numbers with documentation.
• Periodically re-validate spreadsheets. This should include verification of cell formulas and a manual reverification of spreadsheet calculations.

Documentation

The following information is key to document as proof of the validation effort:

• Description of what the spreadsheet does
• Description of formulas used
• Explanation of the relationships of formulas used
• User manual (including keys for any color/formats used)
• Listing of any code (VBA Macros, etc.)
• Test Sheets with expected results, acceptance criteria, and actual results
• Security measures, password maintenance, and user lists
• System requirements such as operating system, spreadsheet software version, and workbook version.

Conclusion

The validation of spreadsheets often gets overlooked on the priority list but is crucial to avoid regulatory issues. There are many resources available online to guide first time validators through the process.

SciCord provides services and products that can fulfill these validation needs – read more about our options here

In the highly regulated pharmaceutical industry, compliance with FDA (U.S. Food and Drug Administration) standards and guidelines is of utmost importance.

Balancing Lab Efficiency with IT and Compliance Requirements

Accurate data management and robust laboratory information management systems (LIMS) play a critical role in meeting these regulatory requirements. To ensure the effectiveness of LIMS solutions, pharmaceutical laboratories rely on validation packages designed specifically for FDA compliance.

 What is LIMS Software?

A Laboratory Information Management System (LIMS) is a software solution that streamlines and centralizes data management in a laboratory setting. It helps pharmaceutical laboratories maintain accurate records, improve data traceability, and ensure compliance with regulatory requirements.

 The Importance of Validation in FDA-Compliant Laboratories

 Key Components of Validation Packages for LIMS Software

Validation Packages can vary and include items such as a Validation Plan, Customer Administration Procedures, User Requirements Specification, Functional Requirements Specification, Design Qualification (DQ), Risk Assessment,
Operation Qualification (OQ) Vendor Audit Plan, Vendor Audit Report or Installation Qualification (IQ) or Summary Report, and a Configuration Specification document. Below are descriptions of some of the main components of a validation package.

 Choosing the Right Validation Package

When selecting a validation package for your LIMS software, it’s important to consider the specific needs of your laboratory. Look for a package that aligns with your URS and is designed to meet FDA compliance standards. Additionally, the package should offer ongoing support and updates to ensure continued compliance as regulations evolve.

 Conclusion

Validation packages for LIMS software are a critical component of ensuring that pharmaceutical laboratories remain FDA compliant. By implementing a thorough validation process, laboratories can mitigate the risk of data inaccuracies, streamline their operations, and confidently meet regulatory requirements. Choose the right validation package to support the success of your laboratory’s quality control and data management processes.

 SciCord

SciCord is a hybrid ELN/LIMS, featuring a spreadsheet paradigm, that combines the compliance and structured aspects of a Laboratory Information Management System (LIMS) with the flexibility of an Electronic Laboratory Notebook (ELN). The ELN and LIMS functions integrate seamlessly and enable your company to quickly reap the benefits of enhanced data and time efficiencies as you continue to meet compliance standards and follow GLP.

Introduction

Pharmaceutical labs face the dual challenge of complying with FDA 21 CFR Part 11 regulations and the European Union’s General Data Protection Regulation (GDPR). Both sets of regulations focus on data integrity and security but have distinct requirements. This article explores how pharmaceutical labs can navigate these regulatory landscapes, ensuring compliance with both FDA and GDPR standards.

2. Electronic Records and Signatures
ELNs and LIMS must establish a traceable link between electronic records and signatures. The system should prevent the same signature on multiple documents and ensure each signature specifies the role of the signer (e.g., author, reviewer).

3. Document Security and Audit Trails
Both open and closed systems must maintain detailed audit trails, documenting all changes to electronic records. Records should include the printed name of the signatory, the date and time of signing, and the role associated with the signature.

GDPR: Data Protection and User Rights

1. Purposeful and Lawful Data Processing
The GDPR requires that data processing be lawful, fair, and transparent. Companies must collect data for specific, legitimate purposes and limit the amount of data to what is necessary.

Reconciling FDA and GDPR Compliance

1. Data Retention vs. Right to Erasure
A key conflict between FDA 21 CFR Part 11 and GDPR arises from data retention requirements versus the right to be forgotten. FDA regulations mandate retaining data for specific periods, while GDPR allows individuals to request the deletion of their data. Companies must balance these requirements by ensuring compliance with both regulations where possible.

2. Explicit Consent and Audit Trails
GDPR mandates explicit consent for data collection, while FDA 21 CFR Part 11 focuses on maintaining audit trails. Companies should implement processes that secure explicit consent and document all data collection activities to meet both standards.

The GDPR reaches well beyond the physical boundaries of the EU.

The GDPR applies to international companies that collect data from citizens in any EU member state. According to gdpr.eu, “it imposes obligations onto organizations anywhere, so long as they target or collect data related to people in the EU.” Yes, that’s anywhere in the world. So, every firm that collects data from EU citizens falls under the jurisdiction of this law, even if they are located outside the EU.

SciCord ELN/LIMS: Compliance Solutions

Conclusion
Navigating the regulatory requirements of FDA 21 CFR Part 11 and GDPR is challenging but essential for pharmaceutical labs, or any labs working in a validated industry. SciCord ELN/LIMS provides the necessary tools and features to ensure compliance with both standards, safeguarding data integrity and security while respecting user rights and regulatory mandates.

 

The pharmaceutical industry faces a dilemma every day. On the one hand, the overall success of the industry relies on painstakingly thorough R&D, testing, and trials that, ironically, eliminate the vast majority of product ideas and eventually yield a relatively small number of safe and effective products. However, the research, development, lab testing, and clinical trials necessary to get a new product to market are hugely expensive.

In 2017, Scott Gottlieb told the members of the Regulatory Affairs Professional Society (RAPS):

The challenge for pharmaceutical companies is to discover ways to make product development less expensive without making it less effective – to learn how to work more productively without sacrificing accuracy or precision.

A leading-edge ELN (Electronic Laboratory Notebook) designed for use by pharmaceuticals helps companies achieve both of these goals.

Are you skeptical? Read on to discover:

• Why do pharmaceutical labs need an ELN?
• What characteristics make an ELN robust and user-friendly?
• How to approach the implementation of your ELN for maximum efficiency and acceptance.

How an ELN Helps Labs Increase Productivity & Reduce Costs

Before we address how an ELN helps labs increase productivity and reduce costs, let’s define what an ELN is and how it differs from a LIMS (Laboratory Information Management System).

Put simply, an ELN is a digital version of the ubiquitous traditional lab notebook used for hundreds of years by researchers in many fields. Like a paper notebook, an ELN documents thousands of details about lab activity: Who did what? When, where, how, and why did they do it? What happened?

Notice the level of detail suggested by these questions, and how specific they are to an individual lab. That’s a key feature of an ELN; it’s designed to manage unstructured data and adapt to changing workflows. That feature is also a critical difference between an ELN and a LIMS.

A LIMS is designed to manage structured data through workflows that are tightly regulated. Traditionally, LIMS data gathering and management has focused on capturing and analyzing data throughout the lifecycle of the sample. Implementing a LIMS increases the lab’s standardization and accuracy among samples and tests, and also guides and records the usage, maintenance, operation, and calibration of equipment.

There’s disagreement over whether a leading-edge lab should implement an ELN, a LIMS, or a combination of the two. (We will address that issue later.) For now, we’ll focus on the ELN.

An ELN eliminates these difficulties associated with paper notebooks and provides researchers with tools and integration that a paper notebook just can’t provide. For those reasons, an ELN is crucial for cutting-edge pharmaceutical labs. Specifically, an ELN provides:

• Enhanced data creation
  An ELN covers all aspects of data entry, including who generated the data and what materials/resources and machines/instruments were used. E-signatures and time stamps explain when the analyst performed the testing. Automated calculations yield fewer math errors, greater precision, and significant time efficiencies. Simply put, an ELN helps researchers generate more accurate data faster. This means increased productivity and efficiency.
  An ELN also makes errors easier to spot. Since data ranges can be specified, results outside the range are instantly flagged and can be quickly analyzed to discover the cause of the discrepancy. This capability helps researchers notice errors of transposition or substitution and prevents a domino effect of incorrect calculations driven by a single error.
• Improved sample preparation
  Complex sample formulations are often automated for greater measurement accuracy. A robust ELN links the equipment, instruments, and resources used in the sampling process to the data derived from each sample. Preparation documents are detailed, easier to complete, and legible (There’s no more need to decipher someone’s handwriting.)
• Easier data retrieval
  An ELN’s search function lets you access data from a specific experiment that was performed by a certain researcher and yielded results that meet exact parameters.  Thanks to layers of search functionality, the most robust ELNs can pinpoint and display–in just a few seconds–the exact data needed. (You can say goodbye to trips to the vault in the basement!)
• A balanced approach to data protection and data sharing
  Giving the right people access to data increases communication and the flow of ideas. It speeds the research process and encourages camaraderie and a shared sense of purpose. However, unbridled access can foster errors, clashes between researchers, compliance issues, and myriad situations that can put the integrity of the data at risk.  An ELN lets you determine who can access what information. You specify the hierarchy of the project, stipulate who can use the data, and limit who can change the data. These features allow you to protect the data while you share it.
• Better lab stewardship
  At the heart of lab stewardship is the desire to improve quality while reducing lab costs. An ELN helps labs increase their stewardship by streamlining activities, reducing redundancies, and increasing efficiency.
• Lab-wide Integration and Collaboration
  This may be the biggest, overarching benefit. Integration reduces redundancies and the effects of human error while increasing communication and collaboration. Collaboration spawns ideas, generates teamwork, and enhances the work environment. Together, they facilitate lab-wide stewardship. Errors will still occur, but less frequently. And when they do, having an ELN in place makes them easier to spot and easier to correct.
  With an ELN, all researchers can access the data they need, but no researcher should be able to access sensitive data without authorization. Layers of protection guard the data from unauthorized changes while electronic signatures and time/date stamps provide an audit trail.

Characteristics of a Robust and User-friendly ELN

You’ve decided that an ELN makes sense for your lab. Now you need to select an ELN that will serve you well today and into the future. What traits make an ELN powerful, adaptable, and easy to use?

A second benefit of spreadsheet-based ELNs is that they have been scientists’ “tool of choice” for decades now. Excel is now over 30 years old. It’s more dynamic than it used to be, but is essentially the same tool researchers have relied on for years. An ELN based on a spreadsheet feels ‘right’ to many researchers. That results in decreased training costs resulting from 1) greater acceptance among scientists who view a spreadsheet as a valued tool, and 2) easier and faster integration since that format is familiar.

• Simplicity
  A strong notebook is a simple notebook in terms of how easy it is to understand and use on a daily basis. Simple notebooks are intuitive. They make it easy for researchers to take detailed notes (and locate them weeks or months later), to document equipment usage and calibration details, and to manage every aspect of the sampling process, from chemical inventory to sampling techniques.
• Compatibility
  An ELN needs to integrate with all your lab’s other tools. To do this effectively, it needs an API (Application Programming Interface) layer that can communicate with them. The usefulness of an ELN drops greatly if it requires you to “retool” all the other systems in order to implement it fully.

No ELN can guarantee that a lab will be compliant. Human actions ultimately determine whether a lab meets compliance standards. However, the software needs to meet technical requirements for compliance including a comprehensive and easy-to-follow audit trail and a framework that encourages lab-wide SOPs that meet compliance guidelines.

The most common objection to a cloud-based solution is data integrity. However, a responsible ELN provider will secure your data with redundant server data and backups, and will also provide regular archives to you for local storage. This guarantees your data can not be lost and allows you to switch providers if needed without sacrificing data continuity.

How to Implement Your ELN Successfully and Efficiently

“Implementing an ELN occurs as a transition–not at a fixed point in time.” Key people in your transition team will need to repeat that saying to themselves and others during the process. You’ll facilitate the implementation if you:

• Expect some resistance
  Among the researchers in your lab, you’re likely to encounter some or all of these objections to an ELN:
  • “There’s no real need to change.” These people may admit that the current procedures lack in some ways, but they fail to see a pressing need to disrupt the status quo.
  • “Our data won’t be secure, so all our work will be compromised.” This fear used to be more prevalent, but with increased levels of protection, has diminished, however, some scientists–especially those who meticulously follow data safety protocols and adhere to GLP –are still reluctant to trust an ELN.
  • “An electronic system will add one more layer of difficulty to our work.” Laboratory science is a complex world of testing and discovery that demands attention to detail and intense focus. Some scientists worry that an ELN will add an unnecessary level of complexity that will muddle or derail their professional focus and lead to costly errors.
  • “An electronic system is too expensive.” Each ELN is tailored to the lab that uses it. The cost varies based upon the number of users, the scale of the lab’s required services, and whether the ELN is hosted or located on-premise.
• Carefully choose the time you switch to an ELN
  There will never be a perfect moment to switch from paper notebooks to an ELN. Research and experiments already in progress will be disrupted. Everyone’s productivity will dip briefly while he or she acclimates to the ELN. However, given the financial benefits of implementing an ELN, waiting for the perfect moment could be very costly, both in terms of the rate of getting new products to market and in additional ROI the lab could generate with an efficient ELN. Unless the lab is facing a crisis, the best time to transition to an ELN is probably now.
• Take full advantage of the support team supplied by the ELN provider
  A good ELN provider will supply you with a support team during installation and transition. An excellent provider will make ongoing support available to you as part of their service. Having access to knowledgeable support personnel smooths the transition, calms the fears and doubts, and helps everyone adapt quicker.

How SciCord Provides a Powerful, Integrated Solution

SciCord is a spreadsheet-based hybrid ELN/LIMS that combines the compliance and structured aspects of a Laboratory Information Management System (LIMS) with the flexibility of an Electronic Laboratory Notebook (ELN). The ELN and LIMS functions integrate seamlessly and enable your company to quickly reap the benefits of enhanced data and time efficiencies as you continue to meet compliance standards and follow GLP.

Spreadsheets, Their Data, and Security

• Excel-based system with standard templates that can be adapted for your lab’s needs. New templates can be created by your lab personnel or by SciCord.
• Life-cycle-based program that records each step of each of your lab’s projects.
• To preserve data integrity, the document life cycle offers 3 levels of review – Self, Peer, or Peer Reviewer and Approver
• Audit history shows current and previous data as well as person and reason for change.
• Spreadsheet pages contain predefined calculations. Outlier data is automatically flagged.
• Documents and graphics can be added to the page or inserted as a separate page.
• Instruments can be linked directly to the page; reports can be permanently stored.

Document navigation and search

• Unique query function combines standard word/phrase search for Documents, Samples, and Resources
• Includes standard and customizable “Views” that can be filtered, sorted, ordered, named, and persisted for each user.

Asset management

• Records the location, ID, calibration details, expiration, and additional details of each asset.
• Assets can be linked via an interface connection.
• Includes resource usage details based on the Assets usage within the lab.

• Ability to take complex testing processes and simplify them in easy-to-follow steps, automatic calculations, and reporting.
• Work Requests generate tasks for lab personnel.

Creation of Permanent Records

• Template-based system saves time and reduces errors via automated calculations.
• Stores all sample results which can be queried. Specifications can be utilized.
• Instantly generates of Certificate of Analysis
• Compatible with visualization programs