Academic CRO Strengthens Compliance

Toward the end of a long winter, an internationally renowned academic clinical institution based in Philadelphia, Pennsylvania, chose Cerulean Associates LLC to provide a full review and compliance gap assessment of its FDA data integrity and HIPAA security controls. The organization was on the cusp of rapid growth, running multiple clinical trials for its customers […]

Rapid FDA Recordkeeping

FDA is citing firms more and more for inadequate recordkeeping and record retention. From electronic recordkeeping systems to all paper to a hybrid reality, firms need to manage their documents and emails and records to ensure compliance without risking greater liability and causing greater cost. “Keeping everything” is no solution – and going it alone […]

Data Integrity Training

FDA’s emphasis on data integrity and electronic record compliance causes anxiety, confusion and frustration. What is “data integrity” as it relates to day-to-day activities? to data entry versus data review and manipulation and reporting? to data transmittal from one system to another? to data archives of historical records? And who is responsible for data integrity?  […]

FDA Part 11, Pre-Approval Inspections and Clinical Data Integrity

Getting ready to submit a new medicine or product for FDA approval is a hectic, anxious time. Worry that FDA will raise questions about data integrity and Part 11 only adds to the stress. Amid it all, day-to-day business must go on. And let’s not forget organizational dynamics, cross-functional challenges and tightened budgets. Here’s what […]

FDA Warning Letter Rescue

A mid-sized medical device manufacturer received an FDA warning letter. Cerulean was contacted over other consulting firms for several reasons, in the words of their president: “First, Cerulean’s experience in dealing with our specific issues of quality management. Second, Cerulean’s expertise with small and mid-sized manufacturers meant a greater understanding of how to apply cGMP […]

Learn to Balance Compliance with Competitiveness

A small business supplier to the pharmaceutical and medical device industry was getting overwhelmed with demands that they be compliant with ISO, with cGMPs, and with 21 CFR 11. We defined a defensible strategy for compliance using ISO and elements of compliance with Part 11, and then showed them how and why they did not […]

Develop a Workable, Livable Quality System

Clinical research organizations that work with very vulnerable patient populations have to maintain the strictest confidentiality while ensuring FDA compliance and sponsor support. For one CRO based in Califorinia, they originally hired us to perform a mock FDA audit and conduct cGCP training. As we got in, it became clear that a mock audit was […]

Simplify Processes to be More Compliant

Suppliers to pharmaceutical and medical device companies have to strike a balance between compliance for some customers while satisfying all the rest. It leads to complicated workflows and inconsistent control. What if you could streamline your processes and improve compliance? For one supplier of a critical component to both drug and device companies, that’s exactly […]

Top-Notch, Practical Solutions

When it comes to records and document policies, procedures and controls, Cerulean goes beyond “best practices” to practicalities and realistic solutions.  Our managing director spent his career putting in place records management departments, IT departments and ensuring compliance with 21 CFR Part 11 and EU Annex 11.  Today, John Avellanet helps clients solve their records […]

Reduce Records Risks

Despite all the media alerts and scare stories of executive emails coming back to haunt companies, records retention requirements are far more complicated and risky than simply emails taken out of context.  Firms that do not understand the myriad of ways that federal, state, and international laws require proper records management will find themselves struggling […]