So I got a press announcement from FDA this week announcing it was embarking on a “major hiring initiative” to fill more than 1,300 positions within the next several months as part of a multi-year hiring effort. The new employees will be medical officers, consumer safety officers, health care and regulatory scientists, and other such professionals involved in protecting the public from unsafe food and drug products. And I said, “Great! FDA is finally stepping up to its charter and working to provide the manpower demanded for a truly effective safety monitoring and inspection program.”

I read on. It turns out that many of these positions will be located in the Washington metropolitan area, specifically Rockville, Silver Spring, and College Park, MD. That’s logical since that’s where FDA is largely based. And there will also be new hirings across the country in FDA’s five regions, 20 districts, more than 179 resident posts, and the newly created FDA offices overseas.

And I stopped. What was that? “

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Tissue banks and researchers rely on frequent testing and strict cleanroom controls to keep human cell- and tissue-based products alive and free from contamination.

By Sarah Fister Gale

Every year, more than 1.5 million units of allograft tissues harvested from deceased donors are distributed annually for transplant in the U.S. While the risk of bacterial infection from an allograft tissue transplant is extremely low, in an industry where the lives of human patients are at stake, any contamination risk is a serious concern. Fortunately, the industry has established strict protocols for the screening and handling of tissue in the manufacturing environment to effectively manage that risk.

“The current risk of an allograft infection to the average patient appears to be much less than the risk of infections surrounding the operation itself,” notes Joel Osborne, vice president of quality assurance for the Musculoskeletal Transplant Foundation (MTF), an American Association of Tissue Banks (AATB) accredited tissue bank in Edison, NJ. Still, the allograft industry and the FDA are making constant strides to more strictly control contamination in the handling and processing of human tissue-based products.

Patients receiving allograft tissues put their lives in the hands of the companies supplying those products, relying on them to enforce strict tissue reviews, cleaning and disinfecting processes, and monitoring strategies to ensure donor tissue is healthy and free from infection, and that it does not encounter contaminants during processing.

Human tissues intended for transplantation have been regulated by the U.S. Food and Drug Administration (FDA) since 1993 under 21 CFR 1271. All human cells, tissues and cellular, and tissue-based products (HCT/Ps) used for transplant fall into this category, including bone, ligament, skin, and other soft tissues. These requirements were designed to prevent the introduction, transmission, and spread of communicable diseases via HCT/Ps by ensuring that the HCT/Ps do not contain communicable disease agents, are not contaminated, and do not become contaminated during manufacturing.

As part of the ongoing effort to enforce rigorous safety methods, in May 2005, FDA put three new, comprehensive regulations into effect that address manufacturing activities associated with HCT/Ps. The first requires companies that produce and distribute HCT/Ps to register with FDA. The second provides criteria that must be met for donors to be eligible to donate tissues (the “Donor Eligibility” rule). The third rule defines current Good Tissue Practices (cGTPs), which govern the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps; recordkeeping; and the establishment of a quality program.

Many tissue banks also receive accreditation from the AATB, a voluntary accreditation organization that sets standards for tissue banking.

Every step of the way

“HCT/Ps are unlike pharmaceutical products because they are composed of living functional cells,” notes Dr. Scott Burger, principal of Advanced Cell and Gene Therapy, a consulting firm in Chapel Hill, NC. “They can respond to the microenvironment of the patient, taking advantage of their intrinsic biological functions and capabilities, but they are very complex and challenging materials to handle.”

The success of a tissue-based product relies on its ability to stay alive and functional, which dramatically limits sterilization options and requires strictly controlled transportation and handling conditions to maintain that viability. Those limits in larger part define the processing environment.

“A tissue manufacturing facility cannot be a sterile operation because you are working with biomass,” notes Mark Hallworth, pharmaceutical business manager for Particle Measuring Systems in Boulder, CO. “Human tissue is a living organism that can’t be sterilized, so you’ve got to be able to prove you are in control of your processes at all times.”

Figure 1. A CryoLife technician dissects a human heart, retrieving valve and vascular tissue for preservation and eventual implantation. Photo courtesy of CryoLife.Click here to enlarge image

Proving that drives a lot of the environmental controls used by the HCT/P industry, and it begins with evaluating the donor tissue before it ever comes through the door.

The Donor Eligibility rule requires comprehensive screening of the donor’s medical and social histories, and testing of the donor for risk factors and/or clinical evidence of infection due to communicable disease agents and diseases, such as HIV, Hepatitis, or Strep A. The rule also includes requirements for recordkeeping, quarantine, storage, and labeling of the HCT/Ps.

If a donor meets the eligibility requirements, the tissue is removed in a hospital setting using aseptic surgical techniques. At the time of recovery, cultures of the tissue are taken to look for the presence of bacteria, mold, and fungi, with those test results later determining whether the tissue can and will be processed, says MTF’s Osborne. While every processing facility is different, at MTF the donor tissue is frozen at

Non-fire propagating building materials and tools, along with adherence to fire safety standards, have made the cleanroom industry safer and more aware of the potential cost of cleanroom fires

By Vinnie DeGiorgio, FM Global

During the past 30 years, the semiconductor industry has experienced exponential growth that has significantly affected consumers’ daily lives. This growth, however, has come at the expense of semiconductor process-related fires that have caused devastating property damage, production interruption, and loss of market share.

Following the two large fires in Taiwan in 1996 and 1997, respectively, FM Global and other fire protection professionals stepped back and asked, “How can we improve fire safety and change the industry’s track record?”

Ten years later, with the collective efforts of many organizations and individual contributions, the journey toward the fire-safe cleanroom is almost complete.

Factors that have led to this tremendous improvement include the following:

• Widespread use of non-fire propagating construction materials
• Process liquids being heated remotely
• Third-party assessment of process equipment prior to installation
• Improved handling and disposal of silane gas
• Adherence to improved codes and standards

Current state

Released in 1997 by FM Approvals, a Nationally Recognized Testing Laboratory (NRTL), the Cleanroom Materials Flammability Test Protocol (Class 4910) has become the industry standard for the evaluation of construction materials used in cleanrooms.

FM4910 measures two crucial, fire-related elements of a product or material: the fire propagation index (FPI), an indicator of the tendency of a material to ignite and propagate fire, and the smoke damage index (SDI), an indicator of the amount of smoke generated.

For material to be considered non-fire propagating under FM4910, its FPI must be equal to or less than 6.0 and its SDI equal to or less than 0.4. Materials that meet the Cleanroom Materials Flammability Test Protocol do not require, in and of themselves, fixed fire protection when used according to the appropriate FM Global data sheets. Materials listed under FM4910 may burn locally in the ignition area but will not propagate a fire beyond the ignition zone. Additionally, such materials produce little, if any, smoke or corrosive byproducts, thus minimizing non-thermal damage.

Today, there are 17 manufacturers producing nearly 150 different types of FM4910-listed materials. A complete listing of FM4910 materials can be found at www.fmglobal.com/assets/pdf/4910Approved.doc.

This ever-expanding list has led semiconductor tool vendors to build the majority of products (e.g., wet benches) out of FM4910 materials. In fact, for some tool vendors, FM4910 material-constructed tools have become the standard. Tools made with less expensive (but highly combustible) polypropylene or polyvinyl chloride are, in many cases, now available only by special order.

While FM4910 materials are prevalent in semiconductor cleanrooms, they can easily be applied in other industries that utilize cleanrooms, such as the pharmaceutical, biotech, and food processing industries.

Although FM4910 fire-safe materials are helping prevent cleanroom fires, they can’t do it alone.

In the past, the typical fire scenario was a high-energy process liquid immersion heater or hot plate igniting combustible plastic associated with wet benches. Once ignited, the fire was drawn into the process exhaust ductwork, which many times was constructed of combustible plastic. Once the ductwork was ignited, the fire would spread inside the ductwork all the way to the scrubber.

Companies have eliminated the exposure created by combustible process exhaust ductwork by installing ductwork that meets FM Approvals’ Standard for Fume Exhaust Ducts or Fume and Smoke Exhaust Ducts (Class 4922). Even when subjected to a severe fire, FM4922-approved ductwork will not collapse or propagate fire and will release only minimal amounts of smoke.

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Increasingly, new and retrofitted cleanrooms are installing FM4922-approved ductwork; however, a considerable amount of combustible ductwork with no automatic sprinkler protection still remains in some facilities. Installing either FM4922 products or proper sprinkler protection in these cleanrooms is highly recommended.

Replacing combustible ductwork with FM4922-approved ductwork in existing, operating cleanrooms is not as daunting a challenge as it may seem. In fact, a major semiconductor manufacturer has successfully completed such a replacement. To that company, the benefits substantially outweigh the potentially astronomical loss.

Codes/standards

As mentioned previously, adherence to improved codes and standards (see Table 1) has been a significant contributing factor in improving cleanroom fire safety.

Many of these codes/standards recommend the use of fire-safe construction materials for cleanroom applications. In cases where such materials are not used, fixed fire detection and suppression systems are the recommended alternative. If neither measure is taken, the results can be catastrophic.

In 2005, FM Approvals issued an assessment standard for tools used in the semiconductor industry (Class 7701). This assessment standard evaluates the following aspects of semiconductor manufacturing equipment:

• Chemical
• Control and/or safety interlocks
• Electrical
• Ventilation

Currently, before new tools are installed, they often require on-site evaluation at either the manufacturer or client’s facility by a semiconductor specialist on a case-by-case basis. Due to the complexity and diversity of semiconductor manufacturing equipment, this can be a time-consuming and potentially costly endeavor.

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When a tool is evaluated under FM7701, it will only require a spot check after installation, saving tool vendors and semiconductor manufacturing companies significant amounts of time and money. Having fire-safe semiconductor equipment is critical in the event of a fire. Consider the fire damage consequences cited at the outset of this article.

A major semiconductor equipment manufacturer has recently completed the FM7701 assessment and will shortly become the first company to receive formal FM7701 recognition.

Silane gas usage

Silane, more so than other gases used in semiconductor manufacturing, can lead to severe explosions. It is a stable gas but is pyrophoric, which means that under certain conditions it can spontaneously ignite or have delayed ignition that could lead to an explosion.

Silane has been involved in a considerable number of fires. Common scenarios included untreated silane released into combustible fume exhaust ductwork and improper cylinder change-out procedures resulting in leaks at the cylinder connection points.

During the past couple of years, there have been several unfortunate events that have led to a renewed interest in the safe handling of silane. During the past 2 years, Air Products and Chemicals, Inc. organized a series of silane safety seminars held in Taiwan, Korea, China, and Singapore and most recently in Portland, OR. The goal of these highly successful seminars was to educate the audience on the behavior and best protection practices concerning silane.

Open issues

One significant cleanroom fire hazard still needs to be addressed: containers used to store in-process silicon wafers.

Wafer carriers or pods (200-mm wafers) and front-opening unified pods, or FOUPs (300-mm wafers), are currently made of highly combustible materials such as polycarbonate and polypropylene. These pods or FOUPs are typically placed inside vertical storage systems known as stockers. Fire burns for highly combustible materials placed in a vertical array.

FM Approvals issued the “Approval Standard for Wafer Carriers for use in Cleanrooms” (Class 4911). This standard provides testing criteria similar to FM4910 in order for a fire-safe wafer carrier to earn approval.

A supplier of wafer carriers and FOUPs is presently working with FM Approvals to develop a FOUP that will meet the requirements of FM4911 as well as the strict process requirements.

New fire safety products

The products in Table 2 have recently received FM Approvals certification and can improve overall cleanroom fire safety.

Future outlook

The outlook for further progress in cleanroom protection looks very promising. The use of FM4910 materials and FM4922 ductwork is well-established. Current codes and standards support the use of fire-safe materials. Attention needs to be focused toward bringing an FM4911-approved wafer carrier/FOUP to market. Recently released products have provided solutions to areas previously lacking fire-safe alternatives.

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Vinnie DeGiorgio is FM Global’s principal engineer for the semiconductor industry. He has more than 26 years of property loss control and business impact risk assessment experience associated with the semiconductor and related high technology industries. DeGiorgio has a bachelor’s in engineering and a master’s in fire protection engineering. He maintains memberships in the NFPA and SFPE, is a board member of SESHA, and is the secretary of the NFPA 318 Technical Committee on Cleanrooms. More than one out of every three FORTUNE 1,000 companies work with FM Global (www.fmglobal.com) to develop robust property insurance and engineering solutions to protect their business operations from fire, natural disasters, and other types of property risk.

The revision expands the list of materials of concern and provides more examples of sample preparation to help eliminate industry confusion

By Jim Ohlsen, Chair of IEST Working Group CC031

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In February 2008, IEST published the latest revision of IEST-RP-CC031.2: Method for Characterizing Outgassed Organic Compounds from Cleanroom Materials and Components. Five years after the original IEST-RP-CC031.1 version was published, this revision enables the user to scrutinize a greater number of cleanroom materials, components of construction, and polymers that can outgas organic compounds of concern. Experts in contamination control for aerospace, data storage, and microelectronics used their training as engineers, scientists, and educators to help contribute to the revision process. A seminar will be offered at ESTECH 2008 and should be of interest for industry representatives from numerous related fields.

What are the most significant changes from the previous edition?

Sub-section 4.1, “Materials of Interest,” has been expanded to include more than fifty materials, components of construction, and polymers that may outgas organic compounds of concern in cleanrooms or other controlled environments.

Sub-section 4.2, “Organic Compounds of Concern,” now references ISO 14644-8:2006(E), Annex B, thus greatly expanding the list of contaminating chemicals that can be of concern to a microelectronics product or process.

Sub-section 5.1, “Test Material and Sample Preparation,” has been expanded to include more examples of sample preparation such as a solid to solid transfer method; cure times for two-part mixtures, coatings, paints, sealants, and caulks; and sample preparations for homogeneous and non-homogeneous materials.

Finally, sub-section 5.6, “Extensions of Outgas Testing Beyond this RP,” has been added to briefly address testing of the outgassing of a large part, assembly, or complete system that may be in operation.

How do these changes improve the RP and/or make it easier for the user to apply?

These changes improve the RP by enabling the user to scrutinize a greater number of materials, components of construction, and polymers that can outgas organic compounds of concern. Similarly, a list of the number of organic compounds of concern has increased. In addition, more examples of sample preparation are described. Finally, a brief explanation is given of how the test method of this RP can be extended to test the outgassing of a large part, assembly, or complete system that may be in operation.

What leading-edge or innovative technology does the RP incorporate?

The RP incorporates thermal desorption gas chromatography mass spectrometry (TD-GC-MS). Having access to this technology is essential to carrying out the test method described in this RP. Companies that do not have this capability in-house can utilize contract laboratories; thus the test method of this RP is accessible to anyone.

Does the RP help clarify methods or practices that are a source of industry controversy or confusion?

The RP describes a test method appropriate for semiquantitative determination and qualitative characterization of organic compounds outgassed from materials or components exposed to air in cleanrooms or other controlled environments. This RP specifies four outgassing temperatures–50

CAPA systems will factor into survival of firms in regulated life sciences markets

By James Jardine, MasterControl Inc.

The primary objective of a corrective and preventive action (CAPA) is a solution to the problem for which the CAPA was generated. If CAPA efforts are not driving toward a solution they are nothing more than a waste of time and resources. For organizations in regulatory environments, CAPA is an overarching umbrella–all control points flow through to the CAPA system.

Some organizations are suffering from “death by CAPA”–their companies are being strangled because too many elements are included in their CAPA systems. At its most fundamental level, there are just two conceptual ingredients that make up a CAPA system. The first component is the experience, expertise, and wisdom of the personnel involved with conducting CAPA processes. If personnel do not have a prior track record with CAPA, this may be an area where an organization has less control over CAPA activities. The second core facet of CAPA, one where more organizational control can be demonstrated, is process. The CAPA process requires critical thinking and an effective determination of the exact questions that need to be asked in order to come up with proper solutions.

The regulatory perspective

From the standpoint of regulatory agencies like the U.S. Food and Drug Administration (FDA), CAPA is perceived as the central component that affects all control points including design controls, production and process controls, records and documents change controls, material controls, and facility and equipment controls. Since more than half of Form 483 observations and warning letters cite CAPA deficiencies, it is evident that FDA investigators are likely to look first at a company’s CAPA system during their inspections. In recent years, the FDA has been promoting the adoption of closed-loop CAPA systems where CAPA is the tool that drives reports and keeps management informed.

The FDA’s 21 CFR 820, better known as the Quality System Regulation (QSR), may be specifically intended for the regulation of medical device manufacturing but provides good rules of thumb for CAPAs conducted in any GxP environment. The 820.100 regulatory guideline states that:

(a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for:

1. Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product or other quality problems. Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems;
2. Investigating the cause of nonconformities relating to product, processes, and the quality system;
3. Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems;
4. Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device;
5. Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;
6. Ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems; and
7. Submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review.

(b) All activities required under this section, and their results, shall be documented.¹

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In her “Quality Program, CAPA and Audits”² presentation at the 3rd Annual FDA and the Changing Paradigm for HCT/P Regulation Conference, Mary Malarkey, director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research (CBER), succinctly outlined the fundamental expectations of regulatory agencies in regard to CAPA. While some of her comments were addressed specifically toward current Good Tissue Practices (cGTP), these regulatory expectations can reasonably be applied to all GxP processes across the board. Malarkey made the following points:

• Organizations must be able to ensure that appropriate corrective actions pertaining to core current good tissue (or laboratory, manufacturing, clinical, etc.) practice requirements, including re-audits of deficiencies, have been taken and documented as necessary.
• Corrective actions must be verified to ensure that such actions have been effective and are in compliance with current good practices.
• In situations where it is appropriate, corrective actions must include both short-term action to address the immediate problem and long-term actions that will prevent the recurrence of the problem.

Malarkey also referred to guidance documents stating that documentation of corrective actions must include, where appropriate, identification of the affected product and a description of its disposition; the nature of the problem for which a corrective action was required; a description of the corrective action taken; and the date or dates the corrective action took place.

The 21 CFR Part 211.192 regulation and controls guideline was referenced in that same presentation by Malarkey and provides a good insight into regulatory expectations in regards to unexplained discrepancies that might or should lead to a CAPA investigation: “Any unexplained discrepancy (including a percentage of theoretical yield exceeding the maximum or minimum percentages established in master production and control records) or the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated whether or not the batch has already been distributed. The investigation shall extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy. A written record of the investigation shall be made and shall include the conclusions and followup.”²

CAPA essentials

Most companies doing business in regulatory environments could improve their CAPA processes by implementing better methodologies and applying effective risk-based filters.

At minimum, a good closed loop CAPA system is comprised of the following elements:

• Identification
• Prioritization
• Assignment/acknowledgement
• Investigation
• Correction
• Implementation
• Verification
• Close

The first element of a CAPA, of course, is the identified input that opens the CAPA: a customer complaint, a nonconformity report, an out-of-spec finding, an internal audit finding, and so forth. There are four core modules of an open CAPA: issue review, investigation (or failure analysis), effectiveness checks for verification, and preventive action.

Issue review is the evaluation phase, a scoping process where a determination is first made whether or not an investigation is warranted. The three main components of issue review are sometimes referred to as CSG (concern, specifics, and gateway).

Once the concern has been identified, issue review specifics can be defined by asking the five “W” questions:

• What?
• Where?
• When?
• Weight (magnitude)?
• Who?

An organization’s ability to successfully close a CAPA is directly related to how capably it is able to narrow down these five dimensions and arrive at a defensible decision. Designing and utilizing an issue review worksheet can facilitate CAPA investigations and streamline the gathering of accurate and specific answers to these five “W” questions.

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The “gateway” component of CAPA issue review revolves around the impact (safety, hazard, severity, visibility, etc.) and magnitude (i.e., frequency and/or size) of the situation. A gateway score chart can help managers hone in on magnitude specifics based on qualitative and/or likelihood in comparison with descriptions of the input event occurrence (continually, frequently, occasionally, rarely, etc.). Likewise, an impact chart can provide a gateway scorecard for the severity of the event (critical, important, minor, or negligible). Most issues will likely be categorized as important or minor events. Specific scores can be assigned according to impact and magnitude scales to determine if the event is acceptable (no action required), undesirable (may or may not be put in the formal CAPA system), or unacceptable (CAPA opened and a resolution is required).

Taking action

When the CAPA issue review specifics have been defined and impact and magnitude scores have been determined, it is time to take action. Depending on the impact and magnitude results, possible actions will include the following:

Adaptive action: These actions allow the organization to live with or adapt to the issue and continue to operate according to organizational objectives.

Interim/correction actions: “Band-aid” or containment actions alleviate the effects of the issue and buy time before a corrective action is implemented. (Containment is a backup plan if a problem cannot be resolved).

Corrective actions: Problem prevention and containment actions permanently eliminate the issue.

Preventive actions: These actions anticipate potential problems and eliminate the most likely causes of the problems so they are less likely to occur.

Approaches to investigations

As in any problem-solving situation, there are three basic approaches to CAPA investigations:

Trial and error: This is a risky method that may work for some companies, but it also has the potential to exacerbate the problem. A company may get lucky, but it also may complicate the issue.

Design of experiments, fishbone diagrams (a.k.a. Ishikawa diagram), and brainstorming: These quality tools are usually better solutions than trial and error, but they are also dependent on past experience and potentially useless if the root cause lies outside the realm of personnel expertise. Scrap and downtime are potential complications with these approaches.

Comparative approach: A deductive thinking approach is the ideal method in that it provides understanding of what is not the problem. Investigators can use a comparative approach to discover what sets the problem apart. A fact-based, objective comparative approach investigation should yield clues that identify the problem’s root cause, which will then initiate a corrective action.

The PICCC investigation tactic

One valuable investigative tactic is sometimes referred to as the PICCC or PI-cubed methodology (problem, investigate, clues, compare, and cause).

Problem: The first step in the PICCC method is to determine and understand exactly what has gone wrong.

Investigate: Once the problem has been defined, investigators can gather data that can be used in comparisons and determinations of what is not the problem.

Comparison: Asking “is not” questions (comparing time periods, locations, types of defects, etc.) further refines the investigation.

Clues: The clues uncovered during the investigation are inferences of the facts. At this stage, the investigators are finally able to formulate some solid answers as to why the problem has occurred.

Cause: Investigators can now take the clues and build a cause that can explain the problem or deviation. An assessment can be made regarding the impact of the event and preventive measures, if necessary, can be identified and implemented.

At this stage, the Problem Prevention Analysis model (a modified FMEA tool) can be useful for developing mitigation strategies. The model consists of four basic rudiments:

• Result
• Problem
• Prevent
• Contain

CAPA verification and documentation

Every good CAPA process should have a built-in effectiveness checking mechanism to verify and validate that the CAPA system is working. Data tracking is another mandatory component of CAPA that allows an organization to guarantee that all CAPA-related information can be confirmed, monitored, measured, and, if necessary, corrected.

The ability to document CAPAs according to regulatory requirements is another vital factor to take into account. Because regulatory requirements mandate that CAPA data must be easy to access and analyze, every phase of a by-the-book CAPA investigation should be forms based. Automating forms-based processes like CAPA can not only facilitate regulatory compliance but will also save a company time and resources. Commercial off-the-shelf (COTS) software packages are available that can comprehensively document CAPA investigations and integrate the CAPA process with other processes critical to regulatory compliance such as change control, customer complaints, and audits. An effective CAPA software solution should be configurable and user-friendly and should include features such as:

• Automated routing, notification, delivery, escalation, and approval of CAPAs and all related documentation.
• A secure, centralized, and web-based repository for all CAPA documents.
• System oversight of quality incidents that escalate to CAPAs (i.e., customer complaints, audit findings, etc.).
• Efficient reporting capabilities and advanced analytics.
• Form-to-form launching capabilities.
• Revision and approval history tracking features.
• Best-practice electronic forms and workflow routes that can be used out-of-the-box or customized based on company requirements.

With all of the necessary steps in place, an effective CAPA system will provide all of the critical information for companies involved in the life sciences markets to make meeting regulatory requirements easier and conduct their operations using industry best practices without repetitive quality issues, which waste valuable time and resources.

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James Jardine is a marketing communication specialist at MasterControl Inc., a global provider of GxP process and document management software solutions for life science companies (www.mastercontrol.com).

References

1. Title 21 Code of Federal Regulations Part 820–Quality System Regulation, U.S. Food and Drug Administration, updated Mar. 31, 2006.
2. M. Malarkey, “Quality Program, CAPA and Audits,” pres. at 3rd Annual FDA and the Changing Paradigm for HCT/P Regulation Conference, Jan. 25, 2007.