Product category:
Pharmaceutical Processing News
News Release from: Bovis Lend Lease | Subject: Meeting 21 CFR Part 11
Edited by the Processingtalk Editorial
Team on 08 April 2003
Electronic records and signatures
consultancy
Bovis Lend Lease Pharmaceutical division has dedicated consultancy services that have been specifically designed to help companies meet FDA regulations on the use of electronic records and signatures
These services help pharmaceutical companies meet procedural and technical 21 CFR Part 11 requirements in the shortest time possible and with the minimum of fuss Although Part 11 is an enabling legislation intended to govern paperless processes within the pharmaceutical, biological or medical industries, it is often regarded as an onerous set of regulations, which are difficult to meet
This article was originally published on Processingtalk on 1 Aug 2003 at 8.00am (UK)
Related stories
See the world's largest mass flow meter with Able
Able will be exhibiting at the largest oil and gas industry sector exhibition, Offshore Europe 2003, with the largest ever mass flow meter: see it in Aberdeen for 4 days from 2-5 September 2003
Website dedicated to spreadsheet validation
ABB Process Solutions and Wimmer Systems are very excited to announce the release of a new website dedicated to spreadsheet validation
The Pharmaceutical Division's team of experienced consultants can guide companies through the regulatory maze, which has recently been compared to the Y2K compliance issue.
Dr Brian Hatton at Bovis Lend Lease, explained that the services followed a holistic approach that would enable companies to take full advantage of the possibilities offered by Part 11.
"By taking an overview of the whole Part 11 process, our consultants can formulate a specific action plan that can help organisations benefit from the legislation by improving efficiency and developing their operating procedures".
Further reading
New explosive certified reference materials
AccuStandard, a world leader in the synthesis and manufacture of organic, inorganic, and petrochemical chemical reference standards, has developed a new line of explosive certified reference materials
Fipronil Metabolites as reference standards
Fipronil Metabolites as reference standards are now available from AccuStandard, a world leader in the synthesis and manufacture of Organic, Inorganic, and Petrochemical Chemical Reference Standards
No hazardous shipping fees for reference standards
AccuStandard announces the introduction of its new line of inorganic standards, AccuNoHaz, with a 20 mL volume below the cut-off for the IATA regulated hazardous material shipping fees
Applicable to all GxP (GMP, GLP and GCP) IT systems that create, modify, maintain, archive or retrieve electronic records, Part 11 is relevant to pharmaceutical, biological and medical organisations that produce materials for the USA.
This covers the use of electronic signatures and electronic records, including the original data files from which the printed copy has been obtained.
Part 11 is therefore applicable to every GxP-critical computer system producing electronic records since August 20 1997, even if the primary output of the system is a printed, hand-signed paper record.
In Europe the same rules for electronic records are implicit in Annex 11 of the Regulations for Medicinal Products, but are not yet enforced in the same way.
The Bovis Lend Lease team of pharmaceutical experts can help companies get the most out of Part 11 by establishing the most effective ground rules for paperless processes in the pharmaceutical and related industries.
This is achieved by initially completing an on-site inventory and identifying quality-critical systems.
A process of prioritisation then follows which determines the most critical systems to be assessed and remedied first.
The next stage is to assess each system for applicability of and compliance with 21 CFR Part 11.
Finally, any deficiencies identified during the assessment are corrected and upgrades and/or replacement systems validated.
Bovis Lend Lease has unrivalled knowledge of the software systems employed by the pharmaceutical, medical device and healthcare industries, that can be effectively utilised to help companies implement and execute Part 11 policies.
Utilising proven tools, templates and techniques Bovis Lend Lease consultants apply their in-depth understanding of the global pharmaceutical industry, its regulatory requirements and how these regulations are interpreted worldwide to provide independent and pragmatic guidance.
The February 2003 draft guidance document summarising FDA thinking on the scope and application of Part 11 heralds changes to the rule.
It is important that companies continue their Part 11 projects to reach compliance, however there are now alternative means to reduce the cost impact of remediation.
• Bovis Lend Lease: contact details and other news
• Email this article to a colleague
• Register for the free Processingtalk email newsletter
• Processingtalk Home Page
Search the Pro-Talk network of sites
