The customer is at the core of the business. Armed with more choice and power, customers expect businesses to deliver a satisfying experience throughout the sales cycle. Customers are accustomed to simple one-click purchasing and a streamlined full mob…
Paper and manual processes are delaying critical treatments from getting to market. Discover how Life science organizations reduce development time and costs by transitioning to Digital Transaction Management (DTM). And the result? Going digital saves …
This new report from Ardent Partners is based on a survey of 318 Chief Procurement Officers (CPOs) and other procurement leaders from across the country. It examines the agile and innovative strategies, processes, and tools that CPOs and other business…
Discover how legal teams like yours are enjoying an average 70% more efficient execution of everything from NDAs to complex contracts – some from months to just hours – while also better serving their constituents inside and outside the bus…
In today’s fast-paced business environment, the legal department is often the bottleneck to faster execution. Colleagues in procurement, marketing, and sales are demanding greater efficiency from the legal department to accelerate business relati…
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…
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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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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:
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What is Cloud Security? Cloud security is an approach that typically relies upon a specialized – external IT security company – to remotely manage your business’s data integrity. It can …
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