Welcome Guest (Log in, Subscribe
 What's New | Home | About Us | Contact Us | Help Center | Publications | Site Map | Links | Subscription 

Last update:2012.04.04.
 Regulatory Basis  Forum Issues  Intelligence Services  Web Applications  21 CFR Part 11 Compliant Products 

Intelligence Services
21 CFR Part 11
Competency Training
Blend Uniformity
Patent databases

Adobe Acrobat Reader
Where are you now? Intelligence Services > 21 CFR Part 11 > Products > Analytical Chemistry > EQUANT

EQUANT 21 CFR Part 11 Compliant



Within the pharmaceutical and biotechnological industry, control measurements taken at several stages of the manufacturing process ensure that the intended quality of a finished product is maintained. Critical factors affecting the manufacturing process (temperature, pressure, humidity, TOC…) are exclusively monitored by electronic, on-line signal recording systems.

Accordingly, all electronic systems used for the processing and storage of data subject to FDA statutory requirements will be compliant with the provisions of regulation 21 CFR Part 11.

Where measurement and signal recording systems used as process controls are not 21 CFR Part 11 compliant, the regulation requires that they be either upgraded or replaced. Enforcement of this requirement on a middle-size company can affect hundreds of individual systems.

Replace or make it 21 CFR Part 11 compliant?

Not only will a complete replacement of non-compliant systems severely disrupt a company's daily routine, but the resultant financial burden will also be considerable. The expense required for system changeover, its configuration and validation coupled with financial losses incurred due to inevitable production down time, are all strong reasons against complete system replacement. What is the solution then?

Are there 21 CFR Part 11 compliant products on the market?
How do I make my own system compliant with the 21 CFR Part 11 regulations?

EQUANT has been developed by OPULUS as an instrument control software that is the immediate solution to your compliance problems.

Key Features

  • EQUANT receives measured data from the instrument or data collector system through a communication port. The data is then directly stored in a database.
  • On the EQUANT user interface, warning and interference limits can be set, with the data collected being displayed on a control chart. These features facilitate accurate monitoring of the manufacturing process, while providing ready-made decisions for incidental manipulation.
  • Because of the database support features, data can be retained and stored indefinitely, rendering the need for paper-based documentation unnecessary.
  • EQUANT is fully 21 CFR Part 11 compliant and can be integrated into existing systems.
  • Integration of EQUANT into a new system is fast, requiring considerably less time and expense than traditional program development.

System requirements

  • Intel Pentium 200 MHz or compatible processor
  • 64 MB of memory
  • 150 MB free hard disk space
  • Windows 98, ME or NT 4.0 SP6+ or 2000 SP1 or XP operating system
  • Internet Explorer 5.5 or later
  • CD ROM drive
  • SVGA color monitor set to 800x600 graphical resolution with high color

DQ-IQ-OQ-PQ and 21 CFR part 11

Regulatory compliance in the pharmaceutical, biotechnology, and medical device, industries is the foundation of good business practices. DQ-IQ-OQ-PQ documents for EQUANT provide significant support to reduce the risk of non-compliance.

DQ (Design Qualification) - is the foundation of good science & good compliance practices. You cannot get more out of a system that has been built into it. DQ is the tool & methodology to make the evaluation of suitability for specific requirements, including worst-case-scenario. DQ also provides the baseline for meaningful Performance Qualification (PQ) monitoring; without DQ, PQ flounders, it does not exist. 21 CFR Part 11 compliance is a major functionality relative to Design Qualification.
In the first part let us consider what may be the most important questions to ask relative to 21 CFR Part 11 DQ. STOP

DQ supports the functional & quality specifications designed into EQUANT. Documentary proof of DQ compliance includes:

  1. Software Validation Plan,
  2. Software Validation Summary,
  3. 21 CFR Part 11 Validation Summary,
  4. Measurement Performance Design Summary, and
  5. Measurement Compliance Summary

IQ (Installation Qualification) - IQ supports the requirement for proper installation and acceptance qualification for EQUANT. Documentary proof of IQ compliance includes:

  1. Receipt & acceptance checklist,
  2. Physical & electrical compliance checklist,
  3. Environmental compliance checklist,
  4. Training compliance checklist, and
  5. Final IQ Summary

OQ (Operational Qualification) - OQ supports the specification compliant functioning of the system. Documentary proof of OQ compliance includes:

  1. 21 CFR Part 11 operational specification checklist,
  2. Software operational specification checklist,
  3. Instrument interface operational specification checklist,
  4. Instrument operational specification checklist, and
  5. Final OQ Summary

PQ (Performance Qualification) - PQ supports quality evaluation & quality compliance management of the system. PQ compliance models include:

  1. 21 CFR Part 11 compliance models,
  2. SQC models for instrument qualification review,
  3. SQC models for method qualification review,
  4. SQC models for vendor qualification review, and
  5. SQC models for OOS investigations
21 CFR Part 11 Issues
Various aspects of electronic records and electronic signatures
Forum Database
Almost 100,000 searchable messages from 16 working newsgroups. Updated regularly.
Warning Letters Knowledge Base
An extremely versatile database that will assist familiarization with the regulatory requirements
Competency Trainings & Exams
Multimedia enriched learning materials, exercises and exams.
On-line Trainings & Exams
Web-based learning materials, exercises and exams

back Back
--| What's New | Home | About Us | Contact Us | Help Center | Publications | Site Map | Links | Subscription |--
© 2001-2003 OPULUS® is licensed to BioMondex Ltd. All rights reserved. Please read the disclaimer.