Engineering / Enterprise IT

Best Practices: Concept to Manufacturing

It takes the concerted efforts of many people to take a product from an idea, or concept, to a final product. It starts with generating ideas of how to solve a problem, or improve upon an existing design. Ideas for new products must be conceived, vetted, discussed, tested, and refined until an optimal solution is found. Rushing through this critical phase of product development prohibits truly innovative design.

Having the right tools at your disposal and employing best practices can make all the difference. SOLIDWORKS Solutions provide you with a full suite of tools that enable you to quickly and fluidly create and capture concepts and transfer these into solid models that can easily validated and used ultimately to manufacture the product—all in one fully integrated system.

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Biotechnology / Enterprise IT

ISO 13485 – Change? Do I Have to??

Once a standard has reached the Final Draft International Standard (FDIS) stage, comments and objections have been addressed. Each technical reason is addressed in a comments resolution meeting, so that the parties resolve issues before the standard is published. So in effect, the standard has been approved at this point, and only very technical issues would be addressed before its publication.

Accordingly, many companies have a conundrum if they want to maintain both ISO 9001 and ISO 13485 certification: How to comply with the varied requirements within only one quality system. The array of opportunity may not be as broad in terms of rationalizing how to do business as an outlier. In other words this standard is now at a new level of application based on these three points:

  1. Any actions taken by a business must be measures for controlling risk
  2. Critical factors must be evaluated as Risk and Opportunistic (R&O) driven outcomes
  3. As a result of 1&2 it is explicitly imperative to make planning a tangible and documented activity with appropriate review and actions at executive-level decision-making

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Biotechnology / Enterprise IT

Clinical Study eTMF Manager

The management of a Trial Master File (TMF) for a clinical study goes beyond simply managing the creation, review and approval of content that is included in a TMF. Each clinical study brings about its own level of documentation, complexity, collaboration, information exchange, milestones and activities which must be managed as evidence of GCP compliance and the scientific credibility of the clinical study. The ability to manage all of the interactions required by all participants and contributors, such as sponsors, CROs, vendors and study sites in a secure and organized manner ensures the completeness, compliance and “audit readiness” of a clinical trial and Trial Master File (TMF).

The MasterControl eTMF Manager™ is an electronic trial master file management solution designed to enable real-time visibility into the status of all activities pertaining to a clinical study. Based on the TMF Reference Model, the eTMF Manager provides management of all documents, tasks, milestones and activities (such as monitoring visits and audits) required during a clinical trial, while allowing both sponsors and CROs to track the progress of pending, ongoing, and completed actions.

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Biotechnology / Enterprise IT

CAPA Toolkit

MasterControl has invested over 240 expert hours into the creation of this CAPA Toolkit that provides all the materials needed to build an efficient, compliant CAPA program.Download to gain access to the following CAPA Management information:Four Webin…