Rules and Regulations

Rules and regulations

I need hardly tell you that scientific instruments and their uses are governed by a lot of regulation. I for one find it very reassuring to know that the manufacturer of my analytical instruments is well aware of the relevant legislation and has taken the necessary steps to comply. In the following article I would like to mention two key regulatory areas in relation to Coulter Counters: use of electronic records and compliance with current Good Manufacturing Practices (cGMPs).

The rules and regulations I refer to in this article are actually American ones, but the fact that Beckman Coulter’s Coulter Counter products comply with such strict standards will be equally comforting to buyers anywhere.

Under US rules, organisations using electronic records must comply with the Electronic Records and Electronic Signatures Rule (21 CFR Part 11). This aims to improve the organisation’s quality control and to protect the public. Because instruments such as Beckman Coulter’s Multisizer 3 and 4 Coulter Counters generate electronic records, their systems must comply with this rule.

Beckman Coulter’s Coulter Counters make it easy. You simply select the 21 CFR Part 11 option in the software menu and the system is automatically reconfigured to comply with it. The software also offers a number of other security level options and customisations. As always, Meritics can advise on how your specific needs can be met.

As part of its commitment to meeting the strict requirements of the United States’ current Good Manufacturing Practices (cGMPs) for medical devices, Beckman Coulter has a comprehensive package of measures that address all aspects of validation. It’s called the ‘V-Check Program’.

V-Check covers all relevant aspects of the life cycle of the instrument, from its development to its continuing performance verification (SQ, DQ, IQ, OQ and PQ), providing the necessary documentation in each case. This documentation can be shown to the authorities as proof that the instrument has been properly validated.

For users, the V-Check program gives assurance that the instrument is fit for purpose and will continue to perform its intended tasks to a consistent standard. Importantly, Beckman Coulter and its V-Check program help with ongoing quality checks (PQ). In other words, if you buy a Coulter Counter from Beckman Coulter the support you receive will carry on long into the future.