Untitled Document

Our planning services include:

Compliance-driven planning, including evaluation of the non-conformance situation (483s, warning letters, consent decree), gap analysis, action plan, resource plan, budget development, plan optimization
Performance-driven planning, including evaluation of the performance gap situation (financial limitations, resource limitations, time constraints), gap analysis, action plan, resource plan, budget development, plan optimization
Competitive-driven planning, including evaluation of the competitive gap situation (SWOT analysis, Porter's 5 Forces, KSFs, market and industry dynamics), gap analysis, action plan, resource plan, budget development, plan optimization
Careful evaluation of your business processes to identify areas that could benefit from offshoring

Our compliance services include:

Process review (quality system, design control, document control, manufacturing, service, corrections and removals, clinical trials, MDR, management review)
On-site detailed audits
Non-conformance identification
Scope and effort definition
Remedial action planning
CAPA management advisory
Root cause analysis and documentation
Optimizations advisory
Lessons learned analysis

Our offshoring support services include:

Application of the OLAM Framework to identify specific offshoring objectives
Scope and effort definition
RFP preparation support
Offshoring candidate identification
Proposal review and comparative evaluation
Assistance in contract negotiation
Program and project management advisory
Periodic vendor performance assessments
Optimizations and course corrections advisory
Knowledge transfer assistance
Lessons learned analysis

Our process improvement services include:

Framework selection advisory (SEI-CMMI staged or continuous, 6-Sigma / DMAIC, Baldridge, etc.)
Independent assessments based on the selected framework
Gap analysis
"Black-Belt" advisory
Scope and effort definition
Improvement action planning
Program and project management advisory
Implementation and change management advisory
Lessons learned analysis

	\| Planning \| Compliance \| Offshoring \| Process \|
	Our planning services include: Compliance-driven planning, including evaluation of the non-conformance situation (483s, warning letters, consent decree), gap analysis, action plan, resource plan, budget development, plan optimization Performance-driven planning, including evaluation of the performance gap situation (financial limitations, resource limitations, time constraints), gap analysis, action plan, resource plan, budget development, plan optimization Competitive-driven planning, including evaluation of the competitive gap situation (SWOT analysis, Porter's 5 Forces, KSFs, market and industry dynamics), gap analysis, action plan, resource plan, budget development, plan optimization Careful evaluation of your business processes to identify areas that could benefit from offshoring Our compliance services include: Process review (quality system, design control, document control, manufacturing, service, corrections and removals, clinical trials, MDR, management review) On-site detailed audits Non-conformance identification Scope and effort definition Remedial action planning CAPA management advisory Root cause analysis and documentation Optimizations advisory Lessons learned analysis Our offshoring support services include: Application of the OLAM Framework to identify specific offshoring objectives Scope and effort definition RFP preparation support Offshoring candidate identification Proposal review and comparative evaluation Assistance in contract negotiation Program and project management advisory Periodic vendor performance assessments Optimizations and course corrections advisory Knowledge transfer assistance Lessons learned analysis Our process improvement services include: Framework selection advisory (SEI-CMMI staged or continuous, 6-Sigma / DMAIC, Baldridge, etc.) Independent assessments based on the selected framework Gap analysis "Black-Belt" advisory Scope and effort definition Improvement action planning Program and project management advisory Implementation and change management advisory Lessons learned analysis