Source: http://opulus.com/21_cfr_part_11_compliant_products/equant.asp?link_category=243441
Timestamp: 2018-08-21 06:06:30
Document Index: 740078317

Matched Legal Cases: ['art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11']

Where are you now? Intelligence Services > 21 CFR Part 11 > Products > Analytical Chemistry > EQUANT
Installation guide for EQUANT
How can I purchase 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 systems.
Integration of EQUANT into a new system is fast, requiring considerably less time and expense than traditional program development.
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 supports the functional & quality specifications designed into EQUANT. Documentary proof of DQ compliance includes:
IQ (Installation Qualification) - IQ supports the requirement for proper installation and acceptance qualification for EQUANT. Documentary proof of IQ compliance includes: