Where are you now? Regulatory Basis > 21 CFR Part 11 Issues > Compliant Products > Analytical Chemistry > EQUANT
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.
- 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
- Integration of EQUANT into a new system is fast, requiring considerably less
time and expense than traditional program development.
- 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.
DQ supports the functional
& quality specifications designed into EQUANT. Documentary proof of DQ
- Software Validation Plan,
- Software Validation Summary,
- 21 CFR Part 11 Validation Summary,
- Measurement Performance Design Summary, and
- Measurement Compliance Summary
IQ (Installation Qualification) - IQ supports the
requirement for proper installation and acceptance qualification for
EQUANT. Documentary proof of IQ compliance includes:
- Receipt & acceptance checklist,
- Physical & electrical compliance checklist,
- Environmental compliance checklist,
- Training compliance checklist, and
- Final IQ Summary
OQ (Operational Qualification) - OQ supports the
specification compliant functioning of the system. Documentary proof of OQ
- 21 CFR Part 11 operational specification checklist,
- Software operational specification checklist,
- Instrument interface operational specification checklist,
- Instrument operational specification checklist, and
- Final OQ Summary
PQ (Performance Qualification) - PQ supports quality
evaluation & quality compliance management of the system. PQ compliance
- 21 CFR Part 11 compliance models,
- SQC models for instrument qualification review,
- SQC models for method qualification review,
- SQC models for vendor qualification review, and
- SQC models for OOS investigations