11 Compliance
Consulting

Compliance is not a job function, it’s a cultural attitude. Compliance permeates every department, and combined with effective tools and oversight, results in organizational success.
 
11 Compliance Consulting offers subject matter expertise on quality systems management, with a concentration on compliance to 21 CFR Part 11 and Annex 11 requirements. Our primary emphasis is providing implementation guidance from purchase to deployment of your next EDMS, LMS, or QMS.

Our Services: End-to-End or Specific Needs

“Keeping you in Compliance” is our mission. At 11 Compliance Consulting, we assist clients with all stages of the electronic quality system. We can help with the end-to-end process from system selection to implementation to maintenance; or we can focus in on an individual system, process, or initiative. We are committed to finding the best solution for each client’s specific needs in the most efficient way possible.
We specialize in end-to-end compliance from selection to implementation to validation, maintenance and training to help you stay current with regulations. We are experts and well-versed in: 21 CFR Part 11, GAMP 5, 21 CFR Part 820, ISO 9001, ISO 13485, ISO:/IEC 27041 to name a few.
At system selection, you can count on us to help navigate options and select a vendor for a system including eQMS, eDMS, LMS or QMS. We have you covered, whether you are looking for a gap assessment to determine needs, are issuing an RFP, or want to tap into our years of experience with systems plus staying abreast of the latest regulatory changes. On, implementation, you can focus on your mission knowing the installation and deployment of your system and processes are in good hands by pairing our experts with yours: the perfect combination. We review your workflow and process in developing a plan for configuration as well as for validation where we take the least burdensome approach.
We stay with you after the implementation for training your team, including ‘train the trainer’, high-quality instructional material, and linkage to the LMS. Our managed services include maintenance and evaluation services to ensure smooth operations and help when you need it to quickly resolve issues and minimize downtime.
Learn more about each of our services and how we can help keep you in compliance.

Project management

Efficiency and savings: managing time, resources and increasing quality through proven methodologies and best practices
If you fail to plan, you can plan to fail. We partner with our clients to assist them in developing the best strategy for project implementation and deployment. Deploying new systems is a major endeavor but does not need to disrupt your business. We have years of expertise and experience with QMS, eQMS, LMS and EDMS systems. Using the latest project management tools combined with our industry specific knowledge and approach we can help you:
  • • Plan the execution of projects from start to finish, on time and budget.
  • • Define the scope of the project to ensure your requirements are met.
  • • Implement the project plan to flow seamlessly through the lifespan of the project.
  • • Deploy a strategy to best suit your needs.
Our services provide guidance and leadership in executing projects from planning to completion. Additionally, we offer our clients access to knowledgeable and skilled resources who can help ensure a seamless, integrated implementation.
Keeping you in compliance with a partner who understands the industry and systems
Gears with "strategic partnership" text.

Training Development and Delivery

Complete solution: getting the most from your systems through effective training
You planned it all out, you worked hard, you thought of everything—except training. It comes out of nowhere, at the end of the project, with go-live day looming. You have no time to develop the training, no energy to deliver it, and even less enthusiasm for it. It may feel like it’s a pain to train. Let us make it easy for you and deliver not only system implementation, but the right set of instructions by role. We actually enjoy training! Together, we can help your teams with the right tools and training.
11 Compliance offers a variety of training solutions for any system or budget such as instructional design, train-the-trainer, custom facilitated training and/or eLearning:
  • • Instructional Design creation catered to specific company needs to produce high-quality instructional material.
  • • Train-the-trainer services to familiarize your employee(s) with learning and instruction concepts, teaching them to provide optimized internal learning facilitation.
  • • Custom Training or eLearning development.
  • • Development of tailored documents and materials to ensure useability and uniformity of message.
  • • Marketing and promotional materials designed to boost end user acceptance.
  • • Consulting and configuration of Learning management systems (LMS).
From end users to administrators, our real-world experience allows us to build realistic simulations and examples, so we can train YOUR people on YOUR business processes. Don’t have documented processes? We can help develop those too. We offer custom-made materials, including end-user-conscious SOPs, work instructions, manuals, job aids, and other tools.
Keeping you in compliance with a partner who understands the industry and systems
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
Hand analyzing data charts on clipboard.

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:
  • • Configuration consulting bringing in industry-specific best practices and methodology
  • • New process development and documentation
  • • Problem-solving and issue resolution
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
Green smiley face keyboard key.

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:
  • • Sysadmin as a Service
  • • System Maintenance
  • • End-User Support
  • • Troubleshooting
  • • Issue Resolution
  • • Technical Support Follow-Up
  • • Upgrade Management
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
Continuous compliance on gears.

E.Q.M.S.

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. 11Compliance 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

Testimonials

From my own personal and professional perspective as a veteran IT Software Developer of 39 years, I found the services of 11Compliance to be invaluable and all of the people from your company to be both professional, knowledgeable, and a joy to work with. Of course, I can’t ever say enough about Kate. As a leader in your company, she was truly amazing and definitely appreciate all of her efforts and guidance on our project. I know that originally, the whole reason why we were connected with 11Compliance was because our Software’s vendor personnel resources were already heavily engaged with other customers and didn’t have the bandwidth to assist us with our project deadlines. Personally, I couldn’t have imagined a better fit in regards to your company and ours. And considering that my management requested an even earlier delivery date than previously discussed, I was amazed at how you all handled that and helped us meet our goals. You all did an incredibly amazing job!
Steve Furbacher
I am writing to provide my enthusiastic recommendation for 11Compliance. I have had the pleasure of working with them for 2+ years on high profile QMS Implementation project and I can confidently say that they are a highly capable and professional business. They have consistently demonstrated a deep understanding of their industry and system and has been able to provide innovative solutions to meet the needs of their clients. Their attention to detail and commitment to excellence have been evident in every project they have undertaken. One of the things that impressed me most was their ability to work collaboratively with their clients, ensuring that they fully understood their needs and concerns before providing a solution. They were always willing to go the extra mile to ensure that their clients were satisfied with the end result. In addition to their technical skills, I have found Jo Deyo and Kate Creegan to be especially reliable, responsive, and easy to work with. They always communicate clearly and effectively, and they are proactive in keeping their clients informed throughout the project lifecycle. Overall, I would highly recommend 11 Compliance to any business looking for a capable and reliable partner. They have consistently demonstrated their expertise and professionalism, and I am confident that they will continue to provide excellent service to their clients.
Pete Sosalski
Manager, Business Applications Century Therapeutics

Contact us

11 Compliance is devoted to helping your business.
Find out how we can help you meet your goals.
Phone: (617) 314-6888
Email: [email protected]