New Webinar Highlights No-Risk Approach to Electronic Records-Keeping on Instruments Without a PC

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Analytical data captured during the production of pharmaceutical compounds provides the evidentiary basis for the efficacy and safety of a product; to prevent consequences for customers, the FDA and other official regulatory bodies work on the premise that products are not safe for sale until proven otherwise. A new review and webinar from METTLER TOLEDO provide tips on compliance in record-keeping – so that data are complete, consistent, attributable and accurate.

Electronic Records on Instruments

Review – Electronic records on instruments. Why the concept of "21CFR Part 11 instruments" without a PC is a compliance risk

A new webinar from METTLER TOLEDO explains strategies for a lean way to connect a high percentage of lab instruments into compliant record-keeping systems that can be maintained sustainably at relatively low cost.

A high percentage of FDA warning letters and "483 forms" cite inadequate compliance with data-integrity standards in the pharmaceutical processes of companies that sell products to the US. Remediation activities are very expensive, and can also have personnel consequences at all levels.

Regulatory bodies recommend electronic record-keeping as a way to systematically improve data-integrity practices and enforce compliance. However, many analytical instruments on the market still do not come with software that meets data-integrity standards. As a workaround, some suppliers suggest that instruments be connected directly to LIMS or ERP with no PC or software in between. Although USP 1058 provides clear guidelines on this matter, some laboratory or QC managers still want to avoid computers, as well as the need for validation, and therefore connect the instruments directly, creating 21 CFR Part11-compliant computerized systems.

A new white paper from METTLER TOLEDO explains the shortcomings of this approach with practical examples. It also explains strategies for a lean way to connect a high percentage of lab instruments into compliant record-keeping systems that can be maintained sustainably at relatively low cost.

More details are provided in an accompanying webinar that includes an interview with Bob McDowall, a renowned expert in this field. Registration for this free presentation, to be shown several times in 2018, is open now.

About METTLER TOLEDO
METTLER TOLEDO is a leading global manufacturer of precision instruments. The Company is the world’s largest manufacturer and marketer of weighing instruments for use in laboratory, industrial and food retailing applications. The Company also holds top-three market positions for several related analytical instruments and is a leading provider of automated chemistry systems used in drug and chemical compound discovery and development. In addition, the Company is the world’s largest manufacturer and marketer of metal detection systems used in production and packaging. Additional information about METTLER TOLEDO can be found at http://www.mt.com.

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Christoph Jansen
METTLER TOLEDO
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