© CERULEAN ASSOCIATES LLC

FAQs

Below is a list of questions we are frequently asked (and some we wish were asked)! Click on each question to get the answer or feel free to contact us if your question is not answered below.

What is Lean Compliance?
Lean compliance is a way to simplify and streamline compliance. On average, clients have found it cuts costs and overhead by at least 5% of their total budget each year. This also includes techniques to keep computerized system validation to 13% or less of the total cost of ownership of a system (versus the more traditional 30% cost). By controlling and optimizing regulatory compliance and quality systems, you improve operations, personnel buy-in to compliance, and business flexibility. Our clients have also found that a lean compliance strategy improves morale and fosters improved communication and teamwork.
How can you help with data integrity?
Our managing director and principal, John Avellanet, has spent his entire career dealing with data integrity, compliance, and records retention – both inside and outside of FDA-regulated firms, during inspections and product liability litigation. He is one of few noted international experts in the field:   he has worked with The Sedona Conference to devise rules and guidelines for legal courts and regulators around the world when it comes to assessing a company’s data integrity controls; served on the ISPE’s special interest group on data integrity; and has been interviewed, spoken at conferences, and written widely on challenges with data integrity, Part 11 and Annex 11 (see the complete list in our resource library).  One of the first things we’ll do is talk with you to explore what you hope to achieve through data integrity controls – and also what may not be possible. Typically, we suggest beginning with a data integrity and Part t 11 workshop to bring your team up to speed on today’s enforcement environment and the real-world challenges faced around the globe and across technologies. The goal is to ensure your team understands the scope of the issues – from initial data creation all the way through eventual data disposition and disposal. Then, it’s time to pull together a cross-functional project team to plan and then implement the overall project. Some clients also ask for a data integrity gap analysis audit. Finally, rather than outsourcing, experience has shown it is best to rely upon your people to do some of the “heavy lifting” to implement modern data integrity controls. This is the only way to make sure the knowledge is transferred and any recommended controls are appropriately adapted to your organization.
Do you do computer validation?
We can, but we’d prefer to help you get a bigger bang for your dollar, so when it comes to IT or computer compliance, we prefer to focus on: policy creation (or revision) and training, Part 11 & Annex 11 auditing, long-term data integrity, and cost-effective, risk-based validation strategies. Several clients have turned this around and used our expertise to help them respond to and recover from regulatory inspections that cited poor IT controls and records management issues. Learn more about our cost-conscious, risk-based approach to lean compliance data integrity and Part 11.
Who are your typical clients?
Senior management in small to medium-sized companies, and divisional executives in large enterprises. In general, we focus on those firms regulated by the US Food & Drug Administration (FDA), but several of our clients have been service suppliers to companies that are regulated by the FDA. If you sign a mutual non-disclosure (confidentiality) agreement with us, we can provide you a complete list of client reference contacts. You can also see a list of some of our recent Cerulean clients or read their success stories.
How long has Cerulean been in business?
Co-founder, managing director and principal consultant John Avellanet opened the doors of Cerulean Associates LLC in April 2006 after more than 15 years as an executive accountable for regulatory compliance, quality systems, new product commercialization, IT, records management and data integrity, and trade secret theft prevention. The company’s principal office is located in Williamsburg, Virginia.
How are you different from other consultants?
Our clients repeatedly cite six main reasons why they chose Cerulean:  practical approaches, flexible pricing, real-world “walked-in-those-shoes” experiences, high integrity, strong references from previous clients, and the individual, personal help from Cerulean’s managing director (e.g., we don’t sell you with senior people, and then have junior consultants do the work). Of course, that’s all in addition to Cerulean’s industry-unique guarantees:  free post-project support and our exclusive 12-month audit and inspection warranty. And, because we rely upon positive word-of-mouth and referrals from clients for new business, we have every reason to do the best job possible for you. Cerulean prefers to work with what you have, and enhance and strengthen it rather than recommending major overhauls or complete outsourcing. If this is a sticking point for you, take a look at the ten important reasons not to hire us.
Can I sample your work without hiring you?
Yes – take us up on our offer of a free initial phone or email consultation, even if it’s just for a second opinion. This site should also be providing you some idea of what it’s like to work with us and why many of our clients see Cerulean as a safe choice. You might want to read through our various articles as they relate to your areas of concern (see the article section in our resource library). We’ve also written a well-received, non-promotional article published in BioPharm International on how to choose a consultant (read the online version here). You may also want to subscribe to our newsletter for one year and see if the tips and strategies are of value to you – there is a no-risk, money-back guarantee with SmarterCompliance. And, of course, you can purchase any of our FDA conference reports, industry best practice workbooks or pre-recorded webinars (they come with reference materials).
Do you guarantee your work?
Yes. Unlike many consultancies, Cerulean offers a money-back guarantee, plus 30 days of free retainer-based consulting after our work together is complete. We post the Cerulean guarantee online, and include it in the terms and conditions of any proposal or statement of work we provide. We also give our consulting clients an exclusive twelve months of retainer expertise to handle any audit or inspection – free of charge. We schedule multiple check-ins with you during any project to proactively improve our work and productivity together. Cerulean is a member of the local Virginia Better Business Bureau, and several other industry associations that require strict adherence to published codes of ethics (these are listed in the Cerulean guarantee).
What do you charge?
We post our pricing levels and are constantly calibrating it to ensure we offer the best return on investment to our clients. We offer options for every budget as long as you are willing to be flexible in how the objectives are achieved. Because we keep our overhead low, our costs are generally lower than many other consulting firms. We also offer significant discounts if you have been referred to us by a previous client.
How do you guarantee at least a 5-to-1 return on my investment?
As part of our negotiations with you, we work to figure out – in dollars and cents – what the outcome of any potential work together is worth. To help start the conversation, we can present a sample “dollarized” list of outcomes (such as “writing and training 8 SOPs”) with dollar values based on typical industry costs and research. We then provide you the cost of Cerulean to conduct that service and deliverable. This allows you to easily compare the cost of Cerulean to other options. And this lays out the facts that clearly demonstrate the positive return on your investment in Cerulean’s services.
What does a typical workshop involve?
First, we discuss the outcomes you’d like to see – both the tangible (such as a training session with handouts and sample policies on Part 11 today and data integrity) and the intangible (for instance, obtaining buy-in from the rest of your team and management colleagues to adopt these data integrity principles in preclinical). Then we draft a proposed agenda and review that with you. Our private corporate workshops are highly interactive. We use a mix of presentations, case study examples, and then real-world exercises working through the issues you face so you can start to apply your new knowledge immediately. Depending on your needs and desired outcomes, workshops can be half-days, full days or even two days.
What does a compliance or quality project look like?
Depending on the specifics (putting in place a quality system or records management program, or revising inflexible IT policies or incorporating ICH guidelines into an FDA compliance program), we first have a “walk-through” of your business, operations and current policies or existing SOPs. We then develop a draft strategy, a prioritized plan and timeline, and a set of visuals and diagrams to illustrate the end situation. We review these preliminary drafts with you. Together, we agree on revisions and schedule regular check-ins. As the project moves along, we keep you as informed and as involved as you want. With most of our clients that hire us for a long-term project, we suggest breaking the work apart into incremental stages from which they can walk away at any point. This helps reduce their risk and ensures they get results fast. At the end of the project, we conduct a closeout meeting to ensure your satisfaction with all the deliverables and results. And lastly, we schedule a thirty day post-project check-in to ensure your continuing satisfaction and answer any further questions that might have arisen since our work together.
Is there anything you require before we can work together?
After our initial discussion together (either over the phone or in person), we work up a simple “situation review” that summarizes what was discussed. We then provide you our step-by-step pre-commitment process and our mutual non-disclosure agreement (e.g., confidentiality agreement or NDA). There is no point in going further if you are not willing to invest the time in signing an NDA, either ours or yours. Once the NDA has been signed, we hold a “needs analysis” meeting with you to understand in more detail your objectives and concerns, pencil in a preliminary goals and identify measures of success. We send you a draft proposal that spells out your situation, your needs, your objectives, the value to you of the objectives, and several options for how to accomplish those objectives. Together, we review that for accuracy. Once you are satisfied that we understand what you want to achieve, then we discuss cost options. All along the way, you have many chances to say “no” and disengage.
What options do we have to continue working with you beyond the project or workshop?
All of our clients receive a free subscription to our monthly newsletter of compliance tips and strategies, SmarterCompliance. We also offer retainer-based contracts, and keep all of our former clients informed of new service offerings, webinars, speeches, industry reports and other recent publications. With every client, we like to establish a good relationship so you come to see us as a trusted advisor…even if we only worked together for a one day workshop.
How big is Cerulean?
Cerulean is primarily a one-person company, run by the managing director and principal consultant, John Avellanet. Our “associates” are independent experts in their field with whom we’ve worked and trust. Some of them you can see in our adjunct section. If you decide such additional expertise is necessary, we will either refer you to them directly or sub-contract with them on your behalf as you prefer.
How do you pronounce Cerulean?
Suh · roo · lee · uhn. Like the color blue in a box of crayons. Our managing director’s last name, Avellanet, is pronounced similar to “have-a-bonnet.”
How do I know if I'm ready to hire an outside consultant?
When you begin to perceive an opportunity or a threat is the best time to reach out for independent advice; the worst time is when the crisis has hit and you are forced to react. People do not make good decisions when forced to choose between what few options remain. Once you perceive something new coming down the pike toward you that may be a threat or an opportunity, consider contacting a consultant with expertise in that arena to ask them to help you assess risk, evaluate the opportunities and envision better alternatives. If you like working with the consultant, then consider asking them to help you build consensus within your organization to tackle the new opportunity or threat (several of our clients have asked us to conduct corporate workshops for the sole purpose of motivating a discussion and building consensus in their companies to adopt cross-functional data integrity controls). If that sounds reasonable to you, then please email our managing director to set up an initial phone discussion.
Why should I hire Cerulean versus another consulting firm?
Cerulean is intentionally set up to be a small, more personal consultancy. Because of this, we provide you individual attention, immediate flexibility, and industry-unique consulting guarantees. One thing to consider as well is size and number of clients. Because Cerulean only handles a select number of clients per year, our clients don’t worry about new project managers or subcontractors suddenly showing up, paying for on-the-job training of new consultants still wet behind the ears, and so on. You hire us, you get us. And because we depend on word-of-mouth referrals and recommendations, we have every incentive to do the best job possible. Read more about this here.
Aren't you always looking for ways to expand the scope of our cost?
This is a common, and often valid, complaint about consultants. Our goal is to give you enough knowledge and expertise to be able to solve future issues yourself. So, if we notice other areas that might need shoring up that are outside of our original scope, we will mention it, but unless it directly impacts our work together, we will only offer suggestions for you to consider in the future – including suggestions that do not involve us.
Is thre anything else I should know about before I decide to hire Cerulean?
If you are considering our services, please first read our 10 Important Reasons NOT to Hire Cerulean. And consider taking advantage of our no-obligation offer of a free email or phone consultation – even if it’s just to get a second opinion; it’s a great way to get a real feel for what it would be like to work with us.