21 CFR Part 11
The FDA regulation that defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records. TrackWise supports this life science industry regulation by ensuring the software is compliant using secure, automated processes including CAPA, complaint management and risk management.
21 CFR Part 58
Good laboratory practice for non-clincal laboratory studies. Sparta Systems has software processes available to help pharmaceutical companies electronically manage CAPA, audits, complaints, change control and risk management.
21 CFR Part 110
Current good manufacturing practice in manufacturing, packing, or holding human food. Sparta Systems software solution, TrackWise, ensures compliance, improves quality, and reduces costs by centralizing and integrating quality processes, including management and reporting of deviations, complaint handling, supplier quality, internal and external audits, change control, corrective and preventive actions (CAPA), preventive maintenance and calibration, and others.
21 CFR Part 111
Companies that manufacture, package, label, or hold a dietary supplement, including a dietary supplement manufactured but is packaged or labeled by another person; and a dietary supplement imported or offered for import in any State or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico. This does not pertain to retail establishments holding dietary supplements for the sole purpose of direct retail sale to individual consumers. A retail establishment does not include a warehouse or other storage facility for a retailer or a warehouse or other storage facility that sells directly to individual consumers. Sparta Systems’ Trackwise allows companies to automate vital quality processes that enable conformance to legal regulations including CAPA, auditing and supplier quality management.
21 CFR Part 210
Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs. Sparta Systems software solution, TrackWise, ensures compliance, improves quality, and reduces costs by centralizing and integrating quality processes, including management and reporting of deviations, complaint handling, supplier quality, internal and external audits, change control, corrective and preventive actions (CAPA), preventive maintenance and calibration, and others.
21 CFR Part 211
This ruling requires the manager of any regulatory controlled manufacturing company to manufacture all medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorization and do not place patients at risk due to inadequate safety, quality or efficacy. TrackWise automated quality management software provides automated processes that achieve the highest level of safety and efficiency required by law to meet this FDA standard.
21 CFR Part 1271
Companies are required to create a unified registration and listing system for establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/P's) and to establish donor-eligibility, current good tissue practice, and other procedures to prevent the introduction, transmission, and spread of communicable diseases by HCT/P's. This requires companies to register and list HCT/P's with the Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research, whether or not the HCT/P enters into interstate commerce. Sparta Systems’ Trackwise solutions address the government requirements through automated processed including product registration tracking.
FDASIA (Food and Drug Safety and Innovation Act), Title VII – Drug Supply Chain
In effect as of July 9, 2012, this regulation addresses some of the supplier management challenges, creates new systems and makes other changes to ensure the safety of drugs through domestic and foreign establishment of registrations, inspections and new penalties. TrackWise allows companies to automate vital quality processes that enable conformance to this new legal regulation including CAPA, auditing and supplier quality management.
European Union’s Falsified Medicines Directive
The most commonly used international standard that provides a framework for a quality management system. ISO 9000 is a name given to a family of standards developed to provide a framework around which a quality management system can effectively be based. A quality management system is a common sense and well documented system that ensures consistency and improvement of working practices. This includes the products and services produced. It is based on standards, which specify a procedure for achieving effective quality management. The ISO 9000 family comprises a number of different standards (ISO 9000, ISO 9001 and ISO 9004). Each covers a different facet of the whole.
General requirements for the competence of testing and calibration laboratories is the main ISO standard used by testing and calibration laboratories. It applies directly to those organizations that produce testing and calibration results. The contents of ISO/IEC 17025 standard itself comprises five elements that are Scope, Normative References, Terms and Definitions, Management Requirements and Technical Requirements. The two main sections in ISO/IEC 17025 are Management Requirements and Technical Requirements. Management requirements are primarily related to the operation and effectiveness of the quality management system within the laboratory. Technical requirements include factors which determine the correctness and reliability of the tests and calibrations performed in laboratory.
The OHSAS specification gives requirements for an occupational health and safety management system, to enable an organization to control its OH&S risks and improve its performance. It was developed to be compatible with both the ISO9001 and ISO14001 management systems standards. This includes employee and workplace safety, events, observations, etc.
Good Manufacturing Practice (GMP)
GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act. These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors.
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21 CFR Part 820
Set of regulatory rules set by the U.S. Food and Drug Administration (FDA) for the purpose of ensuring the adequacy of quality systems involved in the manufacture of pharmaceutical products and medical devices. Part 820's GMP regulations are mandatory for all medical device companies. Sparta System’s TrackWise software allows manufacturing companies to comply with the mandated regulation by providing automated software processes that allow more efficient handling of quality systems including CAPA, complaint management and audit execution.
ISO 14001:2004 sets out the criteria for an environmental management system and can be certified to. It does not state requirements for environmental performance, but maps out a framework that a company or organization can follow to set up an effective environmental management system. It can be used by any organization regardless of its activity or sector. Using ISO 14001:2004 can provide assurance to company management and employees as well as external stakeholders that environmental impact is being measured and improved.
ISO 14001 is relevant to every organization, including:
Specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
ISO 16949 specifies, in conjunction with ISO 9001, the quality system requirements for the design, development, production and, when relevant, installation and servicing of automotive-related products.
In addition, it also specifies development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain.
This technical specification is applicable to production and service part organization sites where customer specified parts are manufactured, and can be applied throughout the electronics supply chain.
ISO 17799 is organized into 10 sections: Security policy; Organization of assets and resources; Asset classification and control; Personnel security; Physical and environmental security; Communications and operations management; Access control; Systems development and maintenance; Business continuity management; Compliance. Each section contains the actual clauses and controls that comprise the standard. This is applicable to any manufacturing entity with mfr assets.
Restriction of Hazardous Substances Directive (RoHS)
The Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment 2002/95/EC was adopted in February 2003 by the European Union. The RoHS directive took effect on 1 July 2006, and is required to be enforced and become law in each member state. This directive restricts the use of six hazardous materials (Lead, Mercury, Cadmium, Hexavalent chromium, Polybrominated biphenyls, Polybrominated diphenyl ether) in the manufacture of various types of electronic and electrical equipment but is also considered in the production of cosmetic products as well (i.e. formulations for red lipstick contain lead). It is closely linked with the Waste Electrical and Electronic Equipment Directive (WEEE) 2002/96/EC which sets collection, recycling and recovery targets for electrical goods and is part of a legislative initiative to solve the problem of huge amounts of toxic e-waste. This is a requirement for medical devices and consumer electronics.
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Food Safety Modernization Act (FSMA)
The FDA Food Safety Modernization Act (FSMA) was signed into law by President Obama on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it.
Hazard Analysis & Critical Control Points (HACCP)
Hazard Analysis and Critical Control Points (HACCP) is a systematic management system in which food safety production and preparation is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. HACCP has been applied to a number of industries including cosmetics and pharmaceuticals. HACCP compliance is regulated by 21 CFR Part 120 and 123.
Global Food Safety Initiative (GFSI)
The Global Food Safety Initiative (GFSI) provides a benchmark to ensure consistency between countries and the products that have been certified. These global food safety standards address food, packaging, consumer goods, storage, and distribution for primary producers, manufacturers, and distribution. GFSI-benchmarked food safety standards include: Safe Quality Food (SQF), British Retail Consortium (BRC), International Food Safety (IFS), Food Safety System Certification 22000 (FSSC), and Global GAP (Good Agricultural Practices).
Safe Quality Food (SQF)
Introduced on July 1, 2012, the SQF Code, Ed. 7 serves as the replacement for the SQF 1000 and 2000 codes – offering one food supplier standard for use by all sectors of the food industry, from primary production to transport and distribution.
British Retail Consortium (BRC)
The BRC Global Standards are widely used by suppliers and global retailers. They facilitate standardization of quality, safety, operational criteria and manufacturers’ fulfillment of legal obligations. They also help provide protection to the consumer.
International Food Safety (IFS)
The International Food Standard (IFS) is a global food safety system developed by German and French trade associations to combine the food safety requirements of various retailers into one standard.
Food Safety System Certification 22000 (FSSC)
Food Safety System Certification 22000 (FSSC) is developed for the certification of food safety systems of organizations in the food chain that process or manufacture animal products, perishable vegetal products, products with a long shelf life, (other) food ingredients like additives, vitamins, bio-cultures and food packaging material manufacturing.
Global GAP (Good Agricultural Practices)
Global GAP is the comprehensive solution for retailers and major buyers all over the world who are looking to access certified suppliers and, as a consequence, open up supply chains and widen their merchandise ranges - all vital factors in today’s competitive trading environment. It provides the most widely recognized and trusted standard for farm assurance and food safety. Good Agricultural Practice lays the foundation for sustainable food production in the mainstream of primary product production and are the cornerstone upon which continuous improvements can be made.
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IEEE 1680-2006 EPEAT
EPEAT®-registered electronic products meet environmental measures referred to as criteria. All of the criteria used in EPEAT are based on ANSI-approved public standards, which provide technical details for every criterion and specify how a manufacturer must demonstrate compliance. EPEAT criteria reflect several categories of environmental attributes that cover the full lifecycle of electronic products. The 1680.1 PC and Display standard addresses:
Most EPEAT criteria apply to the characteristics of individual products. For example, one criterion specifies that the product being registered contains no intentionally added cadmium. This type of criterion must be declared for each registered product.
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