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FDA, Industry Grapple with Similar Quality, Technology Challenges

June 16, 2011 By Leave a Comment

Dennis Payton, Executive Director of Product Marketing, Expandable Software, Inc.

With the explosive growth in imported goods to the US and very tight budgets to maintain a level of public safety, what is the FDA doing to insure it maintains a level of service inspection to insure the best protection of the public health? Some obvious answers are to partner with supplying exporting countries but another, perhaps less obvious one is to demand of itself the same level of systems it requires of the medical device industry and other industry segments they oversee. While the FDA pushes even harder on the medical device and lifescience industry toward electronic reporting to the FDA, internally they must not only tackle the challenge to how to handle eMDR and other e-submissions, but also to be much more efficient internally with ever pressing budget cuts.

Electronic Submissions to FDA

As the medical device industry grows, the FDA continues its effort to reach out to industry manufacturers to provide updates, allow the agency to be better connected, and to open an avenue of two way communication in sharing current regulatory thinking.

As medical device industry leaders, we know the attention to detail that is required in setting up a validated, comprehensive and business workable quality system in compliance with FDA regulation. While the FDA’s mandate of safe products in the US marketplace is paramount, there is also a strong mission and vision to make sure there is support for new technology and goods for the advancement of public health.

Turns out the FDA faces some of the same challenges all medical device companies face – how to do more with less while ensuring a level of world-class excellence in an ever-growing global economic supply chain.

In this quarter’s FDA update (Q2, 2011), Mo Samimi of the FDA presents some of the details behind the FDA in defining, setting up, implementing and managing its own internal FDA quality system. Similar to any national or international quality system standards, the FDA for the most part holds itself to some of the same requirements and standards that are required of the medical device industry and other life science, food, and drug industries they regulate.

Mo outlines how the FDA drives their quality system from mission statement and vision to day-to-day operations. He also shows how some of these same goals align with companies that are positioning themselves to become world suppliers of regulated goods with limited resources that must become more efficient over time.

Click here to request the full report.

 

 

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Filed Under: FDA Regulated, Quality Management, Regulatory Tagged With: , ,

Protect Your Firm as FDA Inspections Spike for CROs, Sponsors

May 24, 2011 By 2 Comments

Patrick Stone, President, TradeStone QA

During the last two years of my time with FDA I noticed the amount of Sponsor and CRO inspections triple in number (for CDER, CDRH, & CBER).  CRO’s with less than adequately trained clinic staff and facilities to conduct human clinical trials are receiving warning letters and other FDA regulatory penalties.  The FDA has not conducted enhanced Sponsor or CRO Inspections in many years.  I have observed study sites get warning letters because monitors did not catch informed consent violations early in the trial or for other regulatory and subject record keeping violations.  Catching serious problems early in the trial can prevent adverse events, save time and assets in the long run.

Clinical Investigators and Sponsors  do not want to throw study data out due to preventable errors and inconsistent data.  Monitors for CRO’s and Sponsors should be proficient at the Quality Assurance (QA) they provide and be given adequate time at the study site to ensure regulatory and protocol compliance.

In my time at the FDA, even up to the end of my tenure this past March, I have observed CRO’s collecting original source site documentation from the clinic site at study close-out. I wonder how CRO’s seem to keep missing the basic reason FDA investigator’s conduct data-validation audits.  FDA wants to validate that source documentation match the case report form (CRF) and the sponsor provided data-listing with efficacy end points & adverse event lists.  CRO’s can easily scan the original documents into their system, but physically removing the source documents has conditions.

If a CRO truly wants the original documents for whatever reason, the CRO may certify each copy as a true duplicate of the original (21 CFR describes this process).  In many cases the Clinical Investigator relocates or there is no available space and money to store the records so the sponsor may step in to take over.  There’s not going to be any problem as  long as the FDA can follow the paper trail and review original documents as needed.   Copies may and have been found to be falsified so Investigators will not review paper copies of paper source records.  Electronic printout (output) is a different way to operate now and is acceptable for review.  Sponsors & CRO’s are using more electronic case report forms CRF’s & electronic records in general.  FDA is now requiring field Investigators to review computer systems for 21 CFR part 11 compliance & legacy system maintenance.

Do a search for your competitors’ recent FDA inspections and you will see the trend I am describing.  Build quality into your system from the ground up and you will get quality product results.  Trying to retroactively validate electronic systems and equipment or implement late stage corrections will leave you vulnerable to 483 observations.

You can follow Patrick on Twitter.

 

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Filed Under: FDA Regulated, Medical Devices, Patrick Stone, Pharma/Biotech, Regulatory Tagged With: , , , , ,

Handling a Warning Letter: If At First You Don’t Succeed…

December 10, 2010 By 2 Comments

Last year, we blogged about the most common drug and device GMP 483 items and how to respond to them in writing.  But what if your response is judged inadequate or the FDA otherwise issues a Warning Letter? First off, understand that the agency even at this point is strongly hoping you will voluntarily take the corrective action required so they can settle this case and move on to something else. They are intended to elicit voluntary correction.

However, if you fail to address the issues raised in a Warning Letter, your company can face some serious repercussions, including: recall, seizure, injunction, monetary fine, debarment, disqualification, license suspension or revocation, and prosecution.

The issuance of a Warning Letter certainly raises the stakes after a 483. The violations it contains represent concerns not only of an investigator, but of the District and/or Center Compliance Officers.

Responding to a Warning Letter

Your first action after you receive a Warning Letter should be to immediately notify top management of the letter and give them an idea of the scope of the problem. You should also contact the FDA’s District Director or Compliance Officer. In your written response to them, you should acknowledge your obligation to comply with the law, discuss the impact the issues raised will have on product quality, address any broader or systemic corrections the Warning Letter may have raised, and offer your corrective actions and timetable for completing them.

Ask to meet with the FDA. That meeting is important for a number of reasons, including:

  • Ensuring there is common understanding of GMP concerns
  • Verifying the adequacy of proposed corrections
  • Revealing if further action is planned by the FDA
  • Achieving agreement on how to proceed
  • Providing a written summary, including any clarifications and additional commitments from either side
  • Setting a timetable for periodic updates on progress

Your company can avoid “unnecessary problems” with the FDA as long as your response avoids the following: unrealistic goals, blaming everything on a lack of training, trivializing the product complaints, failing to proofread your correspondence, citing other firms’ practices as an excuse for your own, and failing to implement promised corrections.

Attorney Peter Reichard with Sheppard Mullin works closely with drug and device companies and former FDA officials. He stressed that your Warning Letter response should focus on how you are addressing the problem. “Companies have a tendency to try and explain something, but the FDA is not interested in that,” he says. “They just want to know your plan and that you followed up,” he says.

Part of that plan, Reichard says, is to put together a Warning Letter response team that goes beyond regulatory personnel. Include those involved in business and legal issues and those who keep a handle on resources and expenditures, he advised.

Avoiding Warning Letters

The only proven technique for avoiding enforcement actions [is] establishing an effective Quality System.  And the FDA defines “establish” in this instance as a Quality System that is defined, documented and implemented.

Companies that have SOPs and teams in place to handle process problems tend to do a better job of avoiding Warning Letters, agreed Adam Bloom, an attorney in Reed Smith’s Life Sciences practice.

But the absolute “worst-case” scenario is to become a repeat offender in the eyes of the FDA, he said. “If you said you would fix something, and they come back a year or two later and find the same problems,” they will view you harshly, he added.

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Filed Under: FDA Regulated, Featured, Medical Devices, Pharma/Biotech, Quality Management, Regulatory, Tamar June, Warning Letters/Recalls Tagged With: , , , ,

Balance of “Spirit,” “Letter” of Life Sciences FDA Regulations Key to Compliance

November 9, 2010 By 3 Comments

Russ King, Managing Partner, MethodSense

While on a recent vendor audit of a contract research organization (CRO) we observed a situation we see over and over in this industry: Our client, the sponsor, was looking for compliance within the “spirit” of the regulations. But the CRO’s understanding of regulatory obligation was much narrower and driven by a strong emphasis on “procedures” which was principally informed by ICH E6 and their experience from relatively short one to two day audits by their clients / Sponsors: The CRO was seeking to comply with the “letter” of the regulations as they interpreted them.

And there’s the rub.

Separately, strictly following the “letter” or the “spirit” of the regulations can be problematic. Put them together in a contractual environment and the risk of conflict increases.

A company seeking to follow the letter of the regulations often approaches regulatory obligation as an externally imposed necessity. The company must somehow conform to the documentation requirements because to be cited as non compliant can harm their reputation, create greater regulatory oversight, interfere with contracts and revenue generation, or worse.

Such companies easily gravitate to a narrower interpretation of regulations with a checklist mentality of obligation and the belief that if they can address the checklist items, justify them, and conform to the checklist, then they’ll get a more cost effective path to compliance and achieve auditability. But such benefits are frequently limited because a check list mentality often means either achieving too little or too much in a compliance effort.

On the one hand, checklists can create inflexible approaches that generate costs. We’ve seen many companies using software for critical functions whose strict interpretation of 21 CFR Part 11 controls suggested a checklist of user and functional requirements that far and away exceeded their development budget. They would have achieved compliance by following the checklist, but at a cost that was unnecessary and without creating any real benefits. Once they adjusted their approach to accommodate the intent of Part 11 within the context of their current circumstances, they found a cost effective development solution that added value and achieved FDA compliance.

From another perspective, checklists can produce regulatory shortcomings that generate risk. Organizations that drive their quality culture with checklists tend to have great difficulty in extending good quality practices and oversight company-wide. We’ve seen many organizations with very superficially attractive SOPs but when their operations are examined closely the reach of those SOP’s do not extend with evidentiary assurances beyond what is normally reviewed during a superficial audit. For example, validation of software systems in support of a Sponsor’s project is often the subject of short cuts which can include missing requirements that identify the products’ intended use and informal or incomplete testing intended to replace formal validation. Such short cuts are easily hidden in thick binders of documentation where accountability for validation is difficult to establish without a trained eye. The consequence is the absence of clear accountability for data integrity and, therefore, a risk to the Sponsor’s data.

At the other end of the spectrum are companies whose quality compliance vision is driven by the spirit of the regulations. Typically we see this in Sponsors and their relationships with CROs. Sponsors believe that quality should somehow be imbued into the very fabric of an organization, a belief that can often manifest itself with a Sponsor expressing a quality vision that is made up by selecting for a particular set of tasks the most rigorous relevant regulations for guidance. For CROs, it becomes difficult to meet Sponsor expectations that leave the CRO confused or with the view that the Sponsor does not have clear expectations. As a result, the CRO too often assumes the role of defining for the Sponsor the expectations that the CRO will meet.

The root causes of the conflicts between Sponsors and CROs is primarily the lack of due diligence by the Sponsor to determine the “right fit” of the CRO and the unwillingness of the CRO to understand the expectations of the Sponsor. Sponsors should always thoroughly audit their vendors as part of their vendor selection process (not as justification for their vendor choice) and the Sponsor’s regulatory affairs / quality experts should have input on the vendor contract to ensure that their regulatory expectations are a point of contractual obligation. CROs should insist on fully vetting the Sponsor’s expectations before the engagement and be clear in advance what will be accomplished or where a compromise should be made during contract fulfillment. Failure in either regard can mean a costly change of scope down the road or unacceptable project risks.

Every life science company is different and every contractual relationship between life science companies creates opportunities for improvement. Having the right intentions does not by itself create auditable best practices. Generating auditability does not necessarily imply that a company is doing the right thing.

But the life sciences industry has a much better shot at fulfilling its public mission by integrating through cooperation both the Spirit as well as the Letter of the regulations.

Russ King is Managing Partner at MethodSense, Inc.

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Filed Under: FDA Regulated, Quality Management, Regulatory, Risk Management Tagged With: , , ,

Circle of Compliance Part IV: Improve

September 27, 2010 By 1 Comment

Sal Lucido, VP Enterprise Solutions, AssurX

In Part I, Part II and Part III of this series we discussed the benefits of using a closed-loop process for managing regulatory compliance (pictured below). We discussed how setting up Key Performance Indicators (KPIs) that monitor performance to goals is a good way to Check that processes are working properly thus reducing the need to perform manual audits of a given operation. We also looked at how to collect and process problem information ensures that the right information is collected, the problem is contained and that the root cause is identified. This sets us up for the next step, which is to fix the problem by executing a Corrective Preventive Action (CAPA) project.

The primary goal of this step is to implement changes that correct (corrective action) the problems and prevent recurrence (preventive action). This is where we get our payoff; this is where we ‘close’ the loop. Remember the overall goal is to systematically and continuously improve regulatory compliance. The inputs we will need to execute the CAPA project are show in Figure 1 (below).

Corrective Action Inputs

Problem Scope: Determine the boundaries of the problem we are trying to solve. Trending helps determine the scope. If the scope is too narrow the project will not address all of the future potential issues. If the scope is too broad the project may be too time consuming and expensive.

Root Cause(s): In the previous step we determined the root cause or causes. Check that the corrective actions taken in the project address all of the causes.

Project Schedule: Determine how long this project is expected to take or how long you want to allow it to take. Time is money. This will guide your resource loading decisions.

Project Costs: Determine the overall project budget. Include all labor and material costs.

Determining the Root Cause or Causes is a crucial part of the process. Here are two effective methods for making this determination. The Eight Discipline workflow shown in Figure 2 is optimized for larger, multi-member team projects.

8 Discipline Workflow

8 Discipline Workflow

The Five Why Methodology shown in Figure 3 is an effective technique for separating symptoms from causes. The example in the diagram illustrates this process.

5 Why Methodology Principle: Five or more iterations of asking why is generally sufficient to get to a root cause.

Once you have all of this information you can execute the CAPA project. The CAPA project outputs are shown in Figure 4.

Corrective Action Outputs

Action Items: Define and assign each task that needs to be completed. Unassigned tasks never get done.

Due Dates: Refer to your project schedule and consider the order of action item execution to set target due dates for each task. With team projects have each member report progress to due dates. Missing due dates is a symptom of a problem with the project (not enough resources, unclear tasks, etc.). Address these to keep the project on schedule and budget.

Document Changes: If you don’t change the ‘process’ and/or ‘product’, which are documented in your ‘procedures’ and/or ‘specifications’ – then you are not improving your operations. Remember what Einstein said: “Insanity is defined as doing the same thing over and over again and expecting different results.”

Notification and Training: If a tree falls in the forest and no one is around to hear it, does it make a sound? The same can be asked of CAPA projects. If process and products are change and no one is notified or trained on these changes, did we make an improvement? I know the answer to the second question, no.

Verification: Check to make sure the project solved the problem. This step usually takes place sometime after the project is completed. Set up the verification criteria and date before closing the project.

And there you have it – we have closed the loop. We have defined how a closed loop process defined by what I call the “Circle of Compliance” is used to automate a process that continuously “pulls” the operations toward meeting regulations. By replacing a manual ‘audit’ and ‘check’ routine with this process your company saves time and money while improving its ability to comply with industry regulations. This is the definition of a win-win situation.

Sal Lucido is Vice President, Enterprise Solutions at AssurX, Inc. You can follow him athttp://twitter.com/ComplianceTips

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Filed Under: Quality Management, Regulatory, Sal Lucido Tagged With: , , ,

Expandable Software, Inc. and AssurX, Inc. Launch Integrated Solution with Expandable ERP and CATSWeb Quality Management System

September 20, 2010 By 1 Comment

ERP and quality management integration drives life science manufacturer’s solution for managing regulatory compliance

Expandable Software, Inc.Santa Clara, CA, Morgan Hill, CA – Expandable Software, Inc., a developer of ERP software and AssurX, Inc., provider of quality management and regulatory compliance solutions announced the launch of joint products and a partnership that brings critical regulatory compliance solutions to medical device and life science manufacturers. This enterprise-level global solution and partnership has already proven fruitful with a first joint medical device customer, ReVision Optics (RVO).

Revision Optics VUE+“As RVO prepares for expanded Vue+ commercialization, it is important that our quality systems grow and expand as we navigate through regulatory compliance processes,” said Ali Dahi, ReVision Optics’ V.P. Operations. “As we drive our business priorities in preparation for meeting these requirements, our choice of Expandable’s core ERP with integrated extension to CATSWeb help us incrementally bring functionality on line as our business dictates the need.”

The strategic partnership with AssurX reinforces Expandable’s commitment to providing a complete integrated solution for manufacturers competing in the life sciences industry.  Integration with CATSWeb delivers Expandable customers a powerful quality management solution that provides enterprise-wide visibility of quality issues and processes helping medical technology manufacturers meet the stringent requirements of the FDA and other governing bodies.

“What we’re offering Expandable customers is an extremely attractive entry point to a very robust quality management solution,” said Bob Swedroe, CEO of Expandable Software, Inc. “We’ve found that growing medical technology manufacturers have a distinct need for integrated quality management but often delay or forego the investment because of the typical high cost of commitment. Our partnership with AssurX is aimed at providing customers with a tier-one quality solution, integrated with Expandable ERP, that can be deployed by companies that are anywhere from pre-production to the high growth phase of their expansion cycle.

“Connecting the AssurX quality and compliance management system to the Expandable ERP system provides a complete solution for manufacturers, especially life science companies. This allows manufacturers already using the Expandable ERP system to realize the benefits of integrated quality and compliance process functionality. It also extends four pre-configured, 21 CFR Part 11 compliant processes to Expandable’s ERP customers: customer complaint handling, nonconformance tracking, supplier quality and corrective and preventive action (CAPA) management. We are thrilled that Expandable selected AssurX to provide this integrated functionality,” added Sal Lucido, Vice President, Enterprise Solutions, AssurX.

“Our product strategy is to provide a completely integrated enterprise-level solution that medical technology manufacturers can use to establish sound business practices early in their growth cycle,” said Dennis Payton, Expandable’s director of product marketing. “Our relationship with AssurX allows us to provide comprehensive solutions that meet the very demanding long-term needs of medical technology manufacturers at an investment level that is affordable for growing companies.”

About Revision Optics

ReVision Optics, Inc., (RVO) is a privately held corporation headquartered in Lake Forrest, California. The company’s main focus is the research and development of minimally invasive implantable devices for the restoration of reading vision.

ReVision Optics’ current product portfolio includes the Vue+ corneal microlens. Vue+ is a tiny contact lens-like device that is placed just beneath the surface of the eye. The lens is made from a proprietary, optically clear, biocompatible hydrogel that is similar in nature to the natural cornea. The lens is designed to slightly change the shape of the corneal curvature to improve near or reading vision, decreasing the need for reading glasses.

The company is actively pursuing regulatory approvals and market opportunities for the Vue+ worldwide. The Vue+ has received CE mark and is approved for sale in Europe. For more information, please visit www.revisionoptics.com.

*Caution, the Vue+ is an Investigational Device and is limited by United States federal law to investigational use only.

About AssurX

AssurX, Inc., provides highly regulated organizations with enterprise quality management and compliance solutions. With a choice of OnDemand (SaaS) or OnPremise (licensed) software delivery options, AssurX’s flexible, all-in-one system automates quality and compliance processes so issues can be centrally managed. It helps collect, organize, analyze and share information to better manage and improve quality and compliance performance everywhere in your enterprise. More information is available at www.assurx.com.

About Expandable

Expandable Software, Inc. develops, markets and supports an enterprise resource planning (ERP) software suite designed to help executives and managers of fast-growing companies maximize business performance by maintaining visibility and control of manufacturing operations. Expandable’s fully integrated accounting, engineering and manufacturing modules provide a solid back office foundation while CRM, e-business, and supply chain functions deliver front office tools to manage business relationships, and streamline transactions.

The Expandable system is targeted to medical device, high tech and other manufacturers who need a dependable business foundation that will support their growth all the way to the billion dollar mark.

Expandable is located in California’s Silicon Valley.  More information is available at www.expandable.com.

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Filed Under: Company News, FDA Regulated, Medical Devices, Quality Management, Tamar June Tagged With: , , , ,

Savvy Compliance Strategy Part III: How to Track Problems

July 13, 2010 By 4 Comments
Sal Lucido, VP Enterprise Solutions, AssurX

Sal Lucido, VP Enterprise Solutions, AssurX

In previous series of articles Part I and Part II, we discussed the benefits of using a closed-loop process for managing regulatory compliance (pictured below). I also showed how setting up Key Performance Indicators (KPIs) that monitor performance to goals is a good way to Check that processes are working properly, thus reducing the need to perform manual audits of a given operation.

The Circle of Compliance

The Circle of Compliance

Let’s now take a closer look at the Track Problems step. The primary goal of this step is to collect and analyze data related to operational problems. This is a vital prerequisite for the next step in the process: Improve. Remember our overall goal is to systematically and continuously improve regulatory compliance. So let’s first take a look at collecting data.

Collecting data about operational problems sounds like an easy task, but it turns out to be anything but. First of all, there is a cultural stigma associated with anything that is labeled as a problem. This is because, where there is a problem, there is blame. And where there is blame, there are consequences. Given the fact that we are talking about consequences associated with someone’s livelihood, this is not something to take lightly. Therefore it is important to set a “tone from the top” that let’s employees know that the data will be used to improve operational processes and not punish employees. It is also helpful to ask employees to suggest improvement ideas. I’ve even seen some companies acknowledge and reward employees for suggestions that result in positive actions.  These are all good ways to encourage problem reporting. You want to tip the scale in favor of logging problems as shown in the illustration.

Logging Problems

Logging Problems

The next question is, “What data should we be collecting?” Let me start by pointing out that some data is better than no data. Waiting to create the perfect system will result in the loss of valuable information that could have alerted you to looming problems. So at the very least, start collecting data any way that you can.

I have seen hundreds of problem tracking forms spanning many processes and many industries. I’ve created product issue forms, process problem forms, out of spec forms, suggestions forms for industries regulated by the FDA, NERC and the SEC. I’ve summarized four design tips in the next illustration.

The Four S's: Problem Tracking Form Design Tips

The Four S's: Problem Tracking Form Design Tips

Now that you are collecting problem data, what should you do with that data? The high level steps for processing issues are: Identification, Investigation, Immediate Actions, Analysis and Planning for Further Action.

Problem Processing Flowchart

Problem Processing Flowchart

This is a summary of what each of these steps involves:

Identify: Collect problem data from all sources. Route these to someone that can determine immediate actions and investigate the problem.

Investigate: Look into the problem beyond the initial problem report. Look for trends from other sources (employees, vendors, customer) and from similar product and problems.

Immediate Actions: This step may be performed in parallel with or before the Investigate step. Determine if there are any immediate actions that need to be taken to contain the problem. While you are looking for root causes you don’t want the problem to grow or continue to do damage.

Root Cause Analysis: This is different from the initial investigate step in that you now are trying to determine what actually caused the problem. During the investigation you may determine that the problem was a result of operator error. But the root cause analysis may reveal that the operating procedure is unclear and is in fact the root cause of the problem.

Plans for Further Action: Once you have established the root cause you can take actions to Improve operations. In this step you would plan out what those improvement actions will entail, who will implement them, and how long they will take to enact. Typically this Corrective Action project requires management approval to allocate the required resources.

One benefit of this process is that a single Corrective Action project can address multiple problems. See the following illustration.

Investigation Funnel

Investigation Funnel

The next step is to Improve operations through implementing the corrective action project. We will take look at that step in the next article.

Read Part IV.

Sal Lucido is Vice President, Enterprise Solutions at AssurX, Inc. You can follow him at http://twitter.com/ComplianceTips

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Filed Under: Electric Reliability, FDA Regulated, Quality Management, Regulatory, Sal Lucido Tagged With: , , , ,

No News is Big News: SaaS is Configurable!

April 22, 2010 By 1 Comment

cloudcomputing1“There’s nothing to see here folks, move along. Nothing to see here.”

That’s what police usually say when a crowd gathers to watch something new, unusual or just plain interesting.

Reminds me of an article I recently ran across declaring that Software as a Service (SaaS) technology was indeed configurable.  The jist of it was that NetSuite CEO Zach Nelson was attempting to shatter some of the common misperceptions about SaaS during his keynote address at a company’s partner conference in San Francisco last week.

The WebCPA article covering Zach’s speech went on, “Addressing claims that most SaaS solutions are not customizable, Nelson claimed that there are currently 6,600 users utilizing NetSuite’s enterprise resource planning functions, the majority of which are customizable features.”

Extra! Extra! Read all about it: SaaS is configurable, says Zach.  And we’ve blogged about this before, too.

But is this news to anyone?

Apparently it is in some circles. So why has SaaS gotten a bad rap as inflexible?

Blame it on the early days of SaaS, when some providers offered more rigid, “pigeon-holed” solutions, says AssurX Operations Manager Karl Kleinkauf, who’s been in this business nearly twenty years. “In the old days there was something of a ‘take it or leave it’ attitude,” Karl adds.

But that’s all changed in recent years, Karl notes. For starters, the technology has improved and ample bandwidth is more widely available today. Both factors help make SaaS more configurable. But consumer demand also helped make it happen, Karl notes.

In fact, as his own customers get more adept using SaaS for regulatory compliance, they often see other uses for it. “I’ve helped many use our SaaS system for document control and customer complaint handling after they’ve gotten comfortable with it on the compliance side,” Karl says.

So let’s recap: SaaS is flexible, multi-faceted and configurable.

Remember, you didn’t read it here first.

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Filed Under: Quality Management, SaaS & Cloud Computing Tagged With: , , ,

Need for Change Control Never Changes

April 5, 2010 By 2 Comments
Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

They say that change is about the only constant in life (we’ll leave out death and taxes for the sake of this discussion).

And we all got an excellent reminder of that earlier this month when the FDA smacked Boston Scientific by saying the agency would not speed up the review of manufacturing changes required for Boston Scientific to resume selling its implantable heart defibrillators.

 As first reported by The Wall Street Journal, the medical-device maker recalled all seven brands of its defibrillators in March after having failed to receive FDA approval for the manufacturing changes. The company had earlier told physicians that it expected the review to take less time than the typical 30 days, according to the WSJ.

 Boston Scientific submitted the changes to the FDA for approval on March 15 and 16, according to an email sent by a Boston Scientific sales representative to a physician on March 17 that was reviewed by WSJ.

What’s at the core of Boston Scientifics’ problem here? Well, at least part of it is change control failures. As noted in the Journal report, “The Natick, Mass., company’s failure to report the manufacturing changes to the FDA was the latest in a string of problems in following reporting requirements. The FDA is investigating the company’s failure in this recent case as well as past lapses,” an FDA official said.

But Boston Scientific is by no means the only company out there with a shaky hand on change controls. If you are reading this blog and your gut is starting to churn a little, you know who you are.

It may be time to review your change control program, right?

We thought it might help a little to review exactly what change control is, while we’re at it.

Good old Wikipedia defines change control within Quality management systems (QMS) and Information Technology (IT) systems as “a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. It reduces the possibility that unnecessary changes will be introduced to a system without forethought, introducing faults into the system or undoing changes made by other users of software. The goals of a change control procedure usually include minimal disruption to services, reduction in back-out activities, and cost-effective utilization of resources involved in implementing change.”

And that’s a great definition — as far as it goes. What it leaves out is what can go wrong when change control isn’t handled properly.

But we already know what the consequences are when change control isn’t properly managed, don’t we?

ADDITIONAL RESOURCES

For more on the FDA’s change control requirements, go here:

Boston Scientific sees it all a little bit differently. In a March 18 release the company notes that the FDA did recommend approval of an expanded indication of its heart medical devices. However, Boston Scientific has thus far declined to address the FDA’s decision not to review it more quickly.

AssurX will host a complimentary webinar on this important topic April 8, 2010 at 10am PDT. Click here to register.

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Filed Under: FDA Regulated, Michael Causey, Quality Management, Regulatory Tagged With: , , , , , ,

FDA Lifts Curtain on Inspection Process, Rationale

March 25, 2010 By 2 Comments
Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Gotta give the FDA some credit here. In addition to its transparency initiative we’ve talk about before, the agency is also trying to remove some of the mystery about how it handles inspections and other inner workings at the FDA. From where I sit, it appears to be a sincere effort and I believe it is helping outsiders better understand what the FDA is trying to do – and how it is trying to do it.

For example, at the second in a new series of monthly online webinars, FDA’s Michael C. Rogers, deputy director, Office of Regional Operations, said today (March 25, 2010)  tried to outline how an FDA inspection tends to work, and what drives inspectors before, during and after an inspection.

As an aside, Rogers also said that the agency currently has about 1,800 total inspectors across its full portfolio, though food gets the bulk of the bodies. He also said there will be more foreign inspections this year, and that the number should continue to grow.

Inspections are based on risk, Rogers said. In other words, the riskier the potential drug, device or food item, the more likely they will be inspected.

Most inspections are unannounced, Rogers said. Before they go on-site, the inspector on inspection team will look at previous inspection reports and identify what corrective actions were promised during prior inspections. They also prepare inspection tool kits with sampling equipment, info to drive inspection based on guidance documents and the Investigation Operations Manual. They also carry a camera to document evidence.

They also conduct “for cause” inspections driven by consumer complaints or other outside activity.

Typically, the inspection begins with a discussion with management to explain the purpose of the inspection, and they try to learn about the corporate structure and any changes made since last inspection. They also ask about complaints, positive tests or returns. Answers to those questions help FDA inspectors focus their on-site efforts.

Next, they go to the physical manufacturing area. They try to observe and understand the on-site process. They ask about acceptance criteria and want specifics on failures, especially the reasons.

Inspectors also draw a diagram of the facility showing the manufacturing process from start to finish. They’re looking for problems in the system and looking to identify critical control points in the manufacturing process.

FDA inspectors then identify procedures in place and assess if company is actually following them. They also look for controls in place to mitigate any contaminated products.

They also look at training and cleaning programs. They also watch employees while they are actually making the product.

If they find evidence of an adulterated product, they collect evidence based on inspector observations and collect samples to prepare their case for possible legal action in court.

At conclusion of inspection, the FDA team meets again with management. They then inform the top company official what is in the official Form 483. That form documents observations during the inspection but does not include final recommendations. They also ask for the firms corrective actions planned or in place to get into compliance.

These corrective actions are taken into account as agency formulates official recommendations.

After the inspection at the firm, the inspector develops a report back at the home office. It includes evidence collected and what the firm has already agreed to do about any shortcomings.

In some cases firms can offer voluntary corrections. But sometimes the agency decides it needs enforcement action such as a warning letter, and can also impose civil and/or monetary penalties.

The webinar was extremely popular. In fact, it “sold out” so many who tried to join it could not get in to the live event. There will be a recording available on Monday March 29.

UPDATE: Slides are now available from this event here in PDF format.

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Filed Under: FDA Regulated, Food, Medical Devices, Michael Causey, Pharma/Biotech, Regulatory, Risk Management, Uncategorized, Warning Letters/Recalls Tagged With: , , , , , , , ,
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