SciCord

Validation Packages of LIMS Software for FDA Compliant Laboratories

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

Contact Us



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.


Efficiency

Streamlined validation processes save time and resources while minimizing disruption to laboratory operations.

Compliance Assurance

Validation packages are designed to meet FDA regulatory requirements, ensuring that the LIMS software aligns with industry standards.


Data Integrity

Properly validated LIMS software reduces the risk of data integrity issues and helps maintain accurate and reliable records.

Documentation

Well-documented validation processes provide transparency and serve as a reference for audits and inspections.



Featured Contents

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

FDA regulations require pharmaceutical companies to validate their LIMS software to ensure its reliability, accuracy, and security. Validation serves as documented evidence that the software meets the specified requirements and operates consistently within the established parameters. Proper validation helps reduce the risk of data integrity issues and regulatory non-compliance.

Documents are linked together by an index document, and can be retrieved at any time

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.

  • User Requirements Specification (URS): This is the foundational document that outlines the laboratory’s specific needs and requirements for LIMS. It serves as a reference point throughout the validation process.
  • Functional Requirements Specification (FRS): The FRS details how the LIMS software will meet the requirements outlined in the URS. It defines the functionality of the system, such as sample tracking, data storage, and reporting.
  • Installation Qualification (IQ): This phase ensures that the LIMS software is installed correctly and functions as expected in the laboratory environment. It involves hardware and software verification, and documentation is essential for compliance.
  • Operational Qualification (OQ): OQ tests whether the software operates according to predefined specifications. This phase includes testing scenarios for functionality, security, and data integrity.
  • Performance Qualification (PQ): PQ validates that the LIMS software consistently performs in a real laboratory environment. This involves testing under operational conditions to ensure that the system meets its intended use and regulatory requirements.
  • Validation Summary Report: A comprehensive report summarizing the entire validation process, demonstrating that the LIMS software is suitable for its intended purpose and complies with FDA guidelines.

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.

SPACER

Trusted by organizations of all sizes


SPACER

SPACER

What Our Users Say


SPACER

Don’t take our word for it. We exceed our client’s demands everyday to make their research and discovery process simpler and more efficient.


SPACER
“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


SPACER
SPACER

Contact Us

Reach out to Schedule a Meeting and get more information about how SciCord can fit into your lab

Contact Us




SCIENTIFIC RECORDING

info@scicord.com

8601 Six Forks Road, Suite 400, Raleigh, NC 27615

  

All product names, logos, brands and trademarks are property of their respective owners. All company, product and service names used in this web site are for identification purposes only.
Use of these names, logos, brands and trademarks does not imply endorsement or direct affiliation with SciCord, LLC.

The information contained herein is on an “as is” basis, without warranties or conditions of any kind, either express or implied, including, without limitation, any warranties or conditions of title, non-infringement, merchantability, or fitness for a particular purpose.
You agree that you will not rely on and are solely responsible for determining the appropriateness of using the information provided on this web site and assume any risks associated with doing so.



Copyright © 2012-current year SciCord LLC All Rights Reserved.