CONSENT DECREE REMEDIATION
TRACK & TRACE SERIALIZATION ePEDIGREE
AUDITS & REMEDIATION
As a result of a Consent Decree cited by the FDA, companies need to develop, implement and operationalize quality and compliance remediation plans at their locations within strict timelines that may carry huge fines for not meeting its milestones. Our software tools will help you implement your remediation activities much faster and in a consistent manner.
Our Quality, Information Security Audit and Remediation Program is a unified and structured solution that will properly assess, report and remediate your quality processes, software security or resources. At Boston Technology Research, we understand that each company provides a uniques service or product, so our approach is tailored to your specific needs.
Pharmaceutical track and trace regulations will cover over 70% of global medicines by 2017. Serialization, product tracing, product verification and government reporting compliance requirements are growing fast in US and elsewhere. We will help you assess, plan and execute the changes and enhancements necessary to meet these regulations
REGULATORY AND RISK ASSESSMENT SOFTWARE
sFMEA RISK ASSESSMENT APP
Our sFMEA (smart Failure Modes and Effects Analysis) App is a Quantitative Risk Assessment web based solution that determines your system's Risk Priority Number (RPN), through a series of simple steps. This will help you prioritize and mitigate your system's risk.
GxP ASSESSMENT APP
PART 11/ ANNEX 11 APP
sHRA RISK ASSESSMENT APP
Our GxP Assessment Application, it is our Web based solution that determines your system's Regulatory Applicability (SOX, Hipaa, GxP) and business criticality, through a series of simple questions. It also determines the criticality of your system, by adding the weighted value of your answers.
Our Part 11/ Annex 11 Assessment App, it is a Web based solution, that determines your system's Part 11 applicability and gaps through a series of simple questions. The generated report will aid your Part 11 remediations efforts
Our sHRA (smart Hybrid Risk Assessment) App is a Qualitative FMEA, GAMP and PHA hybrid web based solution, that determines your system's risk classification through a series of simple steps. The Application, automates an industry best practice, that will substantially reduce your risk assessment efforts.
INTEGRATED COMPLIANCE SOFTWARE SUITE
SLIC (pronounced SLICK) is our Smart Lifecycle Integrated Change tool. SLIC simplifies change management by using an intuitive interface without sacrificing functionality and depth. SLIC allows the user to create, track and manage all system changes. SLIC uses the latest in risk-based concepts to evaluate and implement your change. This is accomplished by using a value system, based on system and change criticality.
SLIM is our Smart Lifecycle Implementation Management tool. It is an innovative tool to manage the validation lifecycle process. SLIM simplifies the way you execute your validation projects. Its integrated approach uses proven techniques to eliminate redundancies and inefficiencies, which will ultimately allow for quicker system implementation. It was derived from years of industry experience working on numerous implementation projects.
SCMDB is our Smart Configuration Management DataBase that acts as smart repository for IT organizations. This enables our clients to track and control the configuration of their systems at any time. What makes our solution unique is the smart elements and the inrteraction with our other SDLC modules. This allows the generation of reports for Inspection Readiness, System Inventory List and Configuration Management.
© BOSTON TECHNOLOGY RESEARCH 2010-2016
S.M.A.R.T. is our web based System Management Audit Remediation Tool. It brings a structured/ consistent approach to Vendor Audits, Software Security Audits and QMS remediations. Its built in preset library audit topics (security, QMS, Validation, Resources, etc) makes it versatile and useful in many types of audits. SMART uses an online audit agenda creation, interactive client audit remediation activities and generates audit ready reports of your overal system or quality management program.