Services

Project management

Efficiency and Cost Savings Through Strategic Project Execution

At 11 Compliance Consulting, we help clients maximize efficiency, resource utilization, and quality outcomes by applying proven methodologies and industry best practices.

As the saying goes, “If you fail to plan, you plan to fail.” Effective planning is the foundation of success. We collaborate closely with clients to develop strategic project plans that align with defined deliverables while maintaining seamless business continuity throughout execution.

By leveraging modern project management methodologies, including both waterfall and agile frameworks, along with sector-specific knowledge, we help you:

Plan and execute projects from start to finish—on time and within budget
Clearly define project scope to meet all requirements
Implement structured plans that carry through the entire project lifecycle
Deploy tailored strategies aligned with your organization’s goals

Our services offer both strategic guidance and hands-on leadership, from initial planning through to successful completion. We also provide access to skilled professionals who help ensure smooth, integrated implementation.

Partner with a team that understands your industry, your systems, and your compliance priorities. “Your success is Our success”

Comprehensive Training Solutions

Maximizing System Value Through Effective Learning

From end users to administrators, we bring real-world experience to create realistic simulations and hands-on training—centered around your business processes.

And if those processes aren’t yet documented, we can help with that too.

Our training solutions are flexible, scalable, and tailored to your organization’s needs and budget:

eLearning development: Custom content aligned with your workflows and business goals, delivered in clear, high-quality formats.
Train-the-Trainer Programs: Empower your internal team to deliver consistent, effective training with confidence.
Facilitated Training & eLearning: Instructor-led or self-paced options designed for maximum retention and accessibility.
Curriculum development: Addressing learner needs and business culture to ensure curriculum relevance, with clearly defined goals and objectives.
Tailored Documentation: SOPs, user guides, manuals, job aids, and other materials to ensure clarity, usability, and compliance.
User Adoption Support: Marketing and communication materials to drive awareness, engagement, and acceptance.
LMS Consulting: Guidance and configuration support to optimize your learning management system for delivery and tracking.

After months of planning, configuring, and preparing for go-live, training often arrives as a last-minute hurdle. With limited time and resources, it can feel overwhelming.

At 11 Compliance Consulting, we simplify the process by delivering not only expert system implementation but also role-specific training programs that ensure lasting adoption and compliance.

We enjoy training—and it shows. Our passion translates into engaging, customized learning experiences that equip your teams with the knowledge and tools they need to succeed.

Stay compliant with a partner who understands your systems—and knows how to train your people. “Your success is Our success”

SAMPLE JOB AID: Setting up your e-mail signature

SAMPLE JOB AID: Good Documentation Processes

Validation

Quality expertise + efficiency: optimizing and trusting system performance

It can feel daunting to now add validation onto the plate. With teams stretched to cover ongoing operations, a new system rollout, migration, there is limited bandwidth to address. There may not even be the expertise to do validation, and it would be time consuming to try to learn.

At 11 Compliance Consulting, our validation services ensure you have the utmost confidence in your system’s performance. We design our validation processes around your documented business process. Our team focuses on ensuring your system is validated while taking the least burdensome approach, utilizing risk to mitigate testing while not losing sight of data integrity and system security.

• Verification of compliance with FDA 21 CFR part 11 and EMA Annex 11 pertaining to
electronic records.
• Development of Validation Documentation
• Validation Plan
• User Requirement Specifications
• System Specification (Functional, Configuration etc.)
• Installation, Operational, and Performance Qualifications.
• Risk Assessments and migration strategies.
• Final validation report
• Vendor documentation assessment and acceptance strategy
• System usage procedures (see Training)
• Lifecycle management procedures

At 11 Compliance Consulting, our team maintains up-to-date knowledge of regulations and guidelines to provide premier validation services. We also stay up to date on the latest FDA guidance and industry trends. With a wide range of experience, we are well positioned to provide advice and recommendations for compliance improvements for enhanced system performance. We have helped our clients achieve excellent outcomes with their compliance.

Keeping you in compliance with a partner who understands the industry and systems

Configuration

A complete solution: align your processes to fit your needs to help your teams and get the most from your systems

A configuration can make or break system usability. Cookie-cutter solutions can be cumbersome, inadequate, or not intuitive to your company’s processes. Too much design makes it difficult to get anything done. Too little, and you’ll be plagued with quality issues errors, missed handoffs, and confusion.

At 11 Compliance Consulting, we work closely with you to clearly identify your business requirements and end-user needs. Our expertise in configuration and implementation enables us to provide you and your team smooth transition from the initiation and planning phases to the implementation of a robust quality system.

Our skilled professionals provide the following implementation services:

Our team works with you to understand the unique business processes that make your company successful. We identify pain points within current processes with the aim to improve and streamline the processes. We are well versed in moving companies from paper or legacy systems to electronic and can help minimize or eliminate steps within the process. The implementation is tailored to your unique company and workflow. This end-to-end perspective and streamlined approach ensures an efficient implementation.

Keeping you in compliance with a partner who understands the industry and systems

Managed Services & Support

A complete solution: post-implementation, ongoing maintenance for continued performance through managed services and support

Don’t have time or expertise to effectively manage your system? Or you may want to partner for expertise to save time, costs and let your team focus on their mission.

At 11 Compliance Consulting, our System Administration team is trained and ready to provide administrative services for Quality System Software. We can help you develop a custom maintenance plan that will keep your system running smoothly.

We provide the following services to save you time and optimize your investment:

Staying a step ahead: We keep up with system enhancements, software releases, and vendor updates. We monitor and evaluate updates on new functionality that occur monthly, quarterly, semi-annually and annually basis so that we can recommend the best enhancements for your organization. We provide notifications to the right team members following the evaluation. To ensure your team knows how to use any new system features 11 Compliance Consulting also provides end user training. See our training services for more info.

Keeping you in compliance with a partner who understands the industry and systems

eQMS

Quality expertise: Quality Management Systems configured and deployed by quality industry specialists

A Quality System is interconnected.

A Customer Complaint causes a CAPA…

A CAPA causes an Engineering Change…

Documents change as a result of Engineering Changes…

Training is deployed as a result of the Document Change…

We live and breathe this space, so we get it! Each step impacts the whole system, and it’s all AUDITABLE!

11 Compliance will work with you to configure your electronic Quality Management System (eQMS) which will provide your company with peace of mind through one system that suits all your quality needs.

An effective, properly configured eQMS will allow you to bring new products to market earlier than anticipated with the assurance that all regulations have been met. 11 Compliance will help ensure your eQMS meets FDA, ICH, and/or ISO regulations to generate commercialized success. We have helped clients in pharma, medical, compliance and quality assurance achieve quality goals to help contribute to commercial success.

Keeping you in compliance with a partner who understands the industry and systems