Clarity in a regulated environment

Analytical and pharmaceutical laboratories today face a demanding landscape of regulatory requirements and rising costs. 
Clarity Chromatography Software from DataApex delivers the balance laboratories need: a fully validatable, FDA 21 CFR Part 11 and EU Annex 11 compliant solution that is also affordable and backed up by proficient support team. 

Developed under a certified ISO 9001 quality system, Clarity offers transparency, long-term stability, and independence from instrument manufacturers - ensuring laboratories stay compliant and efficient without vendor lock-in.

 
DataApex Clarity

Compliance made simple, performance made affordable

Unlike many enterprise-level systems, Clarity offers full regulatory functionality at a fraction of the cost with permanent (non-subscription) licenses. Its combination of technical rigor, transparency, and affordability makes it the software of choice for:

  • Pharmaceutical and biotech QC/QA labs
  • Contract research organizations (CROs)
  • Academic and government laboratories
  • Development and manufacturing control labs
DataApex Clarity FDA compliance

Clarity in Regulated Environment Clarity Detailed GLP Compliance Overview

ALCOA

The foundation of Clarity’s compliance is built upon following ALCOA principles for data integrity - data must be Attributable, Legible, Contemporaneous, Original, and Accurate. This is, among other functions, achieved by customizable user accounts and rigorous audit trail.

Supporting tools for GLP / 21 CFR Part 11

Validation

Important part of compliance is validation of the computerized system, for this purpose Clarity provides inbuilt features to carry out Installation Qualification (IQ) and Operational Qualification (OQ). With support team readily available to assist with larger scale Performance Qualification (PQ) of the entire system.

DataApex also provides the Declaration of Software Validation (D021) confirming that Clarity development, testing, and verification are performed in accordance with GAMP5 principles.

Clarity Validation Kit Clarity Declaration of SW Validation

Network solution

While Clarity is not a strict client–server system, it supports multi-station network configurations where data are accessible from multiple stations. To this end standard Clarity can be supplemented by Clarity Offline intended for data processing.

Clarity in Network

Connecting with LIMS

Clarity enables cooperation with Laboratory Information Management System (LIMS) via import and exports in varied formats and customizable contents.

Clarity Cooperation with LIMS

Clarity provides the technical means to achieve compliance, but operational responsibility remains with the user organization.