ISO 9000 Quality
The ISO 9000 standard is the most widely known and has perhaps had the most impact of the 13,000+ standards published by the ISO. It serves many different industries and organisations as a guide to quality products, service, and management.
The ISO 9000 quality standards series are aimed at creating the highest possible customer value through consistency throughout the organisation, as well as continuous improvement. It includes:
- Ensuring and defining responsibility and ownership throughout organisations.
- Ensuring adherence to defined policies, procedures and work instructions (ISO documentation) – developed to meet agreed customer product requirements and levels of service
Workbench and ISO 9000 Quality
Ideagen's Workbench provides full history and audit trail throughout the different modules, i.e. every significant action is recorded – who did what and when.
- Workbench manages and controls ISO documentation
- Ensures staff are adequately trained to effectively do their job
- Making sure that the company works to its defined standard (ISO documentation) and highlights areas for improvement
- Reports issues that do not conform to the defined standard
- Reports and actions customer complaints in an accurate and timely manner
- Ensures that an organisation’s equipment is qualified as suitable for use
ISO 14000 Environmental
The purpose of the ISO 14000 standard is to minimize negative impact from organisations on the environment.
Workbench and ISO 14000 Environmental
Workbench controls the Environmental documentation (i.e. how processes should be structured in order to minimize negative environmental impact), supports the training of the standard, manages audits of the standard, manages any incidence that is not in conformance with the standard, and manages the equipment from an environmental perspective.
ISO/TS 16949:2002 Automotive
This is the standard devised specifically by and for those companies involved in the Automotive Industry. It is an extension of the ISO 9001:2000 standard and covers the management and quality of the products as well as the management methods.
Workbench and ISO 16949:2002 Automotive
Workbench supplies a number of tools to enable companies to manage their ISO 16949 accreditation, from the Document Control Module, which handles any of the documentation from policies, and procedures to product specification and manufacturing records, to the NCR, or Issues Management module where product testing anomalies can be reported, action taken to rectify those anomalies, and full KPI and FMEA reports can be generated.
ISO 27001 Information Security
The ISO27000 standards provide best practice guidance on protecting the confidentiality, integrity and availability of the information on which we all depend.
Workbench and ISO27001
Workbench provides the tools for automating vital tasks, such as controlled document approval and issue, and provides easy-to-use audit management tools, for an efficient means of driving ISO 27001 workflows throughout the organisation and ensuring that compliance is upheld.
OHSAS 18001 Health & Safety
OHSAS 18000 is an international occupational health and safety management system specification. It comprises two parts, 18001 and 18002 and embraces BS8800 and a number of other publications.
Workbench and OSHAS 18001
Workbench assists organisations to maintain this compliance with the ability to manage and control all the relevant documentation, audits and assesses all the identified risks, ensures that any and all actions are implemented and follow up assessments undertaken.
FDA/CFR 21 Part 11
The 21 CFR part 11 rule provides requirements under which the Food and Drug Administration (FDA) of America will consider electronic records to be equivalent to paper records, and electronic signatures equivalent to traditional handwritten signatures
Workbench and FDA / 21 CFR Part 11
Workbench Professional addresses the requirements of this standard through the Document Control Module with features such as full audit trails. These audits are available both as an electronic record, and can be printed as an integral report.
A full workflow can be defined at a system level, i.e. all records are controlled in exactly the same way, at a group or “rules” level, i.e. all records matching certain criteria, or at an individual document level. Access to change this workflow is both controlled and traceable.
Sarbanes-Oxley (SOX)
The Sarbanes-Oxley (SOX) Act of 2002 was established as a result of the accounting scandals mainly at Enron and WorldCom that were revealed in 2001. These scandals resulted in billion dollar losses for investors and employees, and the trust from financial markets and general investors was severely damaged. The SOX Act was developed to protect the shareholders and the general public from fraudulent practices and accounting errors in companies.
Workbench and SOX
Workbench provides secure, complete and un-editable audit trail for all changes in documents, i.e. what was changed, who did it and when.Workbench will securely retain records in accordance to company policy. The retention period can be set differently for different types of documents.
Workbench will securely store all types of documents and will make sure that access to documents is strictly controlled, not only for viewing, but for access to edit and modification of metadata.
COMAH
COMAH applies mainly to the chemical industry, but also to some storage activities, explosives and nuclear sites, and other industries where threshold quantities of dangerous substances identified in the Regulations are kept or used.
GAMP / GXP
Good Automated Manufacturing Practice is a set of guidelines as to best practice for automated systems within a manufacturing environment. It was originally established within the pharmaceutical industry by the International Society of Pharmaceutical Engineering. The GAMP 4 Standard is designed to promote the understanding of the regulation and use of automated systems within the pharmaceutical industry.
Additionally, GMP requires that all manufacturing and testing equipment has been qualified as suitable for use, and that all operational methodologies and procedures (such as manufacturing, cleaning, and analytical testing) utilized in the drug manufacturing process have been validated (according to predetermined specifications), to demonstrate that they can perform their purported function(s).
Workbench and GAMP/GXP
An extremely important part of GMP is documentation of every aspect of the process, activities, and operations involved with drug and medical device manufacture. If the documentation showing how the product was made and tested (which enables traceability and, in the event of future problems, recall from the market) is not correct and in order, then the product does not meet the required specification and is considered contaminated (adulterated in the US). Workbench ensures this risk is avoided.