Xybion Corporation

• An integrated approach to GLP
• Xybion has been an industry leader in providing technology and services that support a number of sub-categories for GxP including cGLP, cGMP and cGCP for over 30 years.  Our technology, software and validation services are used by 70% of the top 20 Life Science companies.   Being subject to an every changing environment of government regulations which require certain Best Practices to be followed, LifeScience companies face unique challenges that detract them from their core business.  Xybion is your partner in that we alleviate many issues of GxP and help reduce technology costs designed to support GxP with our integrated approach.
• Why we are different?
• Xybion is truly unique amongst software vendors who typically support GLP as discrete, departmental function.  We provide a broad framework of technology, with underlying BPM designed to facilitate the rapid deployment and customization of a total compliance framework.  Our combined Compliance and Preclinical solutions help companies ensure GLP adherence at the root level.
• How we support GLP?
• A typical example of what must be followed for the pharmaceutical industry is as follows:
• For a drug to be produced in a GxP compliant manner, some specific information technology practices must be followed. Computer systems involved in the development, manufacture and sale of regulated product must meet certain requirements.
• The pharmaceutical industry therefore must by law heed various things:
• Secure logging: each system activity must be registered, in particular what users of the system do, that relate to research, development and manufacturing. The logged information has to be secured appropriately so that it cannot be changed once logged, not even by an administrative user of the system.
• Auditing: an IT system must be able to provide conclusive evidence in litigation cases, to reconstruct the decisions and potential mistakes that were made in developing or manufacturing a medical device, drug or other regulated product.
• Keeping archives: relevant audit information must be kept for a set period. In certain countries, archives must be kept for several decades. Archived information is still subject to the same requirements, but its only purpose is to provided trusted evidence in litigation cases.
• Accountability: Every piece of audited information must have a known author who has signed into the system using an electronic signature. No actions are performed by anonymous individuals.
• Non-repudiation: audit information must be logged in a way that no user could say that the information is invalid, e.g. saying that someone could have tampered with the information. One way of assuring this is the use of digital signatures.
• Stringent record-keeping requirements and traceability: It is necessary to create and to document a chain of decisions that lead from user needs and business goals down to the system design decisions, and the verification of proper system installation and operation.
• Litigation and Regulation Support: Persons bringing lawsuits, and regulators, can subpoena or otherwise demand to obtain certain information which must be available and which must have been maintained according to law. This information must be promptly furnished to them in the format they require. The industry must be able to satisfy such requests promptly at any reasonable time.

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