What is GMP software?
Our GMP compliance software is a cloud-based documentation software designed to design, organize and control documents and workflow in any manufacturing process. It enables the user to create, archive, generate, review and audit all documentation related to the design, development, and manufacturing of a product.
What is regulatory compliance in pharmaceuticals?
Regulatory compliance means being in accordance with the regulations set out by regulators. These regulations are made by the regulatory agencies across the world, whose intention of making these regulations is to ensure the quality of products that are made by organizations in their industry.
What is RIM in pharma?
Regulatory information management (RIM) has become a major focus among pharmaceutical companies. Industry analysts observe that companies are viewing RIM more strategically and seeking to optimise their operational capabilities.
What is a compliance software?
What is Compliance Software? Compliance software is used to continually track, monitor, and audit business processes to ensure they are aligned with applicable legal, industry, and security requirements, organizational policies, plus consumer standards.
What is a CGMP system?
CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.
What are GMP compliance systems?
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
Why is regulatory compliance?
Regulatory compliance helps you protect your business’s resources and reputation. It takes time to build trust with customers, prospects, and vendors, and a big part of that centers on your ethical behavior. Compliance lays the foundation on which you build your company’s reputation.
What is legal and regulatory compliance?
Semantically, compliance means conforming to a rule, such as a spec, policy, pattern or law. Regulatory compliance outlines the goals that organisations want to achieve in their efforts to ensure that they are aware of and take steps to comply with relevant laws, policies, and regulation.
What is vault rim?
Vault RIM provides an authoritative source for regulatory documents and information globally. Content and data converge in a single cloud platform that unifies registration tracking, correspondence and commitments, submission document management, dossier publishing, and regulatory submission archiving.
What is regulatory intelligence in pharmaceutical industry?
In general regulatory intelligence is the monitoring, gathering and analyzing of publicly available and experience based regulatory information to develop a strategy for time- and cost-efficient drug development.
What is a compliance process?
Process compliance is the regulation and maintenance of industry standards and guidelines. Most industries have standards and guidelines relating to the execution of their business processes. Some of these are actual laws and non-compliance can result in stiff penalties or even jail time for company officers.