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| Regulatory Compliance following FDA / EMA / GMP |
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PAS-X is a modularly structured standard product, tailored to the needs of the pharmaceutical industry and developed under consideration of the specific requirements for product software operated in validated environments.
The software is developed in line with the GAMP 5 recommendations and follows a software lifecycle that takes into account product development as well as project management requirements. Werum has established a framework of quality policies, which have been certified as highly useful and
sophisticated.
PAS-X fully covers the entire range of pharmaceutical specification and execution functions, from materials management through to electronic batch recording, while following the GMP requirements according to FDA 21 CFR Part 210, Part 211
and the EU COMMISSION DIRECTIVE 2003/94/EC) plus the GMP Annex 11 for Computerized Systems Guidelines .
The business functions provided by PAS-X functions comply with the GMP regulations, including the duty to describe the manufacturing process, tracking of containers, equipment logbooks or cleaning rules.
Moreover, PAS-X meets the regulatory requirements regarding the handling of Electronic Records and
Electronic Signatures according to 21 CFR Part 11. To ensure compliance, an electronic signature may be demanded not only during day-to-day data entry, but also in special situations, or for the release of electronic batch records.
In our White Paper "Compliance with FDA 21 CFR Part 11" we explain the primary compliance functions of PAS-X.
 White Paper "Compliance with FDA 21 CFR Part 11" pdf (334 KB)
In late 2001 we presented PAS-X and its Part 11 functionalities to an FDA committee.
You may view the corresponding FDA minutes through the following link:
FDA minutes regarding the presentation of the PAS-X 21 CFR Part 11 compliance functions
pdf (37 KB)
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| Further Links |
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The Food and Drug Administration (FDA) establishes regulations and
evaluation criteria relating to products for humans and animals.
They carry out risk analyses and assessments, approve statements on product efficiency within the scope of the approval process for the US market, and monitor the products after their approval.
FDA documents relating to 21 CFR Part 11:
http://www.fda.gov/ora/compliance_ref/part11/default.htm
The European Medicines Agency (EMA) can be regarded as the European counterpart to the FDA for the EU member states.
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The International Society for Pharmaceutical Engineering (ISPE) is an international association of engineers and companies doing business in regulated industries.
The ISPE plays a decisive role in the enforcement of the 21 CFR Part 11 standards
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The GAMP Forum is an ISPE committee and was founded to promote acceptance of the regulations and the use of computer and control systems in the life-sciences industries.
The GAMP Forum's most important publication is the GAMP Guideline which interprets the specifications of FDA and European authorities in the form of GxP (e.g. Good Manufacturing Practises). GAMP 5 was issued in 2007.
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Concept Heidelberg is Germany's leading advanced training and information services provider in the area of pharmaceutical quality assurance and drug safety. Werum takes an active role in their events relating to the IT requirements of the pharmaceutical industry.
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