LabQ - GxP, data integrity and computer systems auditing services

LabQ is a specialised consultancy providing a full range of independent GxP, data integrity and computer systems auditing services as well as offering bespoke clinical IT solutions to pharmaceuticals and CROs.

We have unrivalled experience in setting up quality management systems and performing various GxP and supplier audits, developing risk-based audit programmes and providing inspection readiness review with a global outreach.

How good is your data - data integrity

In this modern era, technology is growing day by day and the reliance on capturing data is also increasing, as are the challenges of securing data and keeping it legible. There are many areas where data integrity could potentially be compromised; such data could originate from lab instruments, site monitoring, CRF entries and many more sources. It is very important to understand best practices for the capture and maintenance of source data as well as record retention (paper or electronic) and how the gaps could easily be filled and regulatory citations or data compromise avoided.

As subject matter experts on source data integrity who also specialise in computer systems quality, our auditors have vast experience in dealing with gap analysis and providing consultancy. This gives LabQ a distinct advantage over other consultants as we provide a joint service where we can help from a quality as well as an information technology perspective.

Audits and inspections - GxP audits, supplier qualification and risk-based programmes

LabQ has been providing specialised and custom QA services to various BioPharmas and CROs at a global level. LabQ primarily operates through its UK office with its operational presence in the US, China, Korea, Singapore and India.

LabQ has vast experience in dealing with various regulations including USFDA, MHRA, EMA, PMDA, MFDA and GCC countries. We have a proven track record of mock inspections and helping achieve inspection readiness in these countries; we also leverage our regional and international resources in providing help to our client's local or regional sites.

Labs, diagnostic and imaging reader' audits

LabQ has specialised auditors with PhD qualifications and a high level of expertise within labs and imaging audits. We also provide auditing of imaging sites and imaging CROs both from a regulatory and exploratory standpoint and (upon request) perform a full 360° gap analysis for companies wanting to know how much of a gap exists between their exploratory vendors in case they need to expand the capabilities to a regulatory scope of work.

IT Solutions - CTMS

LabQ has developed a clinical trial management System (CTMS) called CATMUS. The system serves as a state of the art electronic data capture (eDC) system that not only helps capture and retain source data throughout the retention time but also complies with 21CFR Part11, HIPAA and ISO requirements for privacy and security standards.

LabQ's CTMS provides a perfect platform to capture the data in real time even if there is no internet connectivity and sync as soon as you are connected to the internet.

CATMUS features following modules:

  • project management
  • site selection
  • site initiation and activation
  • site monitoring
  • site closeout
  • training
  • deviation management
  • custom reporting
  • recruitment and retention
  • eCRF.

Quality IT tools - eLearning and eDoc

LabQ provides software development and IT support from its Bangalore and Dubai software houses. LabQ has its own custom built eLearning Management System (eLMS) and document management system (eDMS). We also have experience in developing laboratory information management systems (LIMS) from scratch for our pharma clients.

Products and services

Full QA services:

  • QMS development and / or reworking

Mock inspections:

  • US FDA
  • EMA
  • MHRA
  • China FDA
  • PMDA-Japan
  • MFDS-Korea

GCP audits:

  • Investigator sites
  • CROs
  • Genomics Laboratories (all platforms, DNA/RNA profiling, Single or Multiples sequencing, NGS, other Biomarkers, qPCR, etc)
  • Specialised Laboratories (ELISA, IHC, Tissue processing, FFPE, H&E, FACS, Flow cytometry, Chromatography [HPLC/GCMS/MS], etc)
  • Pathology laboratories
  • Biostorage

GMP audits:

  • Fill finished products
  • API / Intermediaries
  • Medical devices
  • Distribution practices (including cold chain)

Data integrity audits

Pharmacovigilance

  • Call centres
  • Safety collection and reporting
  • EAP
  • IVRS / IWRS
  • IT solution
  • CTMS
  • eLMS
  • Document Management System
  • LIMS
  • Software support

The mission of LabQ International is to provide quality services to pharmaceuticals and CROs in achieving highest standards of quality and data integrity, which in turn could lead to increased patient safety and consumer confidence.

Products and Services

Contact Details

LabQ International Pvt Ltd
32 Diamond Way
Wokingham
RG41 3TU
United Kingdom
Tel: +44 (0)1189 321 6009
Email: itadmin@labq.co.uk
URL: www.labq.co.uk

LabQ is a specialised consultancy providing full range of independent GxP, data integrity and computer systems auditing services as well as offering bespoke clinical IT solutions to pharmaceuticals and CROs.
LabQ has been providing specialised and custom QA services to various BioPharmas and CROs at a global level. LabQ primarily operates through its UK office with its operational presence in the US, China, Korea, Singapore and India.
LabQ’s Clinical Trial Management System (CTMS) called CATMUS provides a perfect platform to capture the data in real time even if there is no internet connectivity and sync as soon as you are connected to the internet.
Make An Enquiry
First Name

Last Name

Email Address

Enquiry


Privacy Policy
We have updated our privacy policy. In the latest update it explains what cookies are and how we use them on our site. To learn more about cookies and their benefits, please view our privacy policy. Please be aware that parts of this site will not function correctly if you disable cookies. By continuing to use this site, you consent to our use of cookies in accordance with our privacy policy unless you have disabled them.