In the traditional compliance approach, Quality Assurance and Compliance are backroom cost centers, piling on non-value added requirements that detract from the company’s ability to innovate and be profitable.

ValGenesis, a Business Intelligence Solutions business partner, would like to invite you to a complimentary webinar to review how an electronic Validation Lifecycle Management System (VLMS) can standardize and improve the efficiency of your current validation process.

In an environment of increased scrutiny by international regulatory organizations, medical device, pharmaceutical and biotechnology companies face new challenges in managing regulatory submissions and information.

FDA regulatory compliance is a mission-critical requirement for medical device manufacturers. If the FDA finds a manufacturer to be non-compliant to or in violation of FDA rules, the consequences can be severe with warning letters, mandatory product recalls, temporary shut-downs, criminal penalties and fines depending on the severity of the violation.

There are times when a white paper comes across our desk that we wish we wrote it.  That's the case with a white paper from DPT Laboratories, a contract development and manufacturing organization. 

BioWorld Today, the newspaper of record for the biotechnology industry, is read by biotechnology professionals worldwide for its hard-hitting, objective news reporting.

Custom systems are treated in the same manner as commercial off-the-shelf (COTS) systems; that is, the proper installation of system components that meet technical requirements is verified, and the system is tested in a validation environment.

The FDA’s General Principles of Software Validation (GPSV), emphasizing how crucial requirements are to successful validation, recognizes the requirements for a successful validation project are difficult, if not impossible, to create accurately and to an adequate level of detail in one pass.

The GAMP guide provides guidance and examples on the application of the principles and framework of GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems to a wide range of systems, from basic instruments to large, complex, distributed control systems.

Documentation is important to demonstrate system validation. The documentation should include a written design of what the system is intended to do and how it will do it. Process Validation is a legal requirement and enforceable under the following guidelines: 501(a)(2)(b) of FD&C Act and cGMP guidance –ICH Q7.