Process validation is the process of ensuring that a manufacturing process consistently produces a product that meets its intended specifications and quality requirements. It involves a series of activities that are performed throughout the product lifecycle to verify that the manufacturing process is capable of consistently producing a product that meets the predetermined specifications and …
Equipment qualification is the process of verifying and documenting that equipment, facilities, and systems are suitable for their intended use and operate consistently within their specified range of parameters. It is an important aspect of ensuring product quality and regulatory compliance in various industries such as pharmaceuticals, biotechnology, medical devices, and food manufacturing. The equipment …
Data integrity refers to the accuracy, completeness, and consistency of data throughout its lifecycle. In other words, data integrity ensures that data is reliable, trustworthy, and has not been altered or manipulated in any way.Data integrity ensures that research findings are reliable and can be reproduced by other scientists. To maintain data integrity, organizations must …
Regulatory compliance refers to the adherence to laws, regulations, and standards that apply to a specific industry or organization. Compliance is essential to avoid legal and financial consequences, maintain reputation, and ensure the safety and well-being of stakeholders. To achieve regulatory compliance, organizations must identify and understand relevant laws and regulations, develop policies and procedures …
Regulatory audits are an important tool used by government agencies to ensure that organizations comply with laws and regulations. These audits are typically conducted by auditors who have been trained to assess an organization’s compliance with applicable laws and regulations. During a regulatory audit, auditors will typically review an organization’s policies and procedures, as well …
What is Dossier??? A dossier is a collection of documents and information about a particular person, organization, or subject. It can be used for various purposes, such as a record of someone’s personal or professional history, a compilation of evidence for legal proceedings, or a report on a company’s financial or operational status. Dossiers can …
A vision statement for a pharmaceutical consultant is a declaration that expresses the organization’s long-term objectives and aspirations and acts as a manual for decision-making. A vision statement for a pharmaceutical consultant should describe the goal of the organisation and what it hopes to accomplish in the future. It should demonstrate the company’s dedication to …
