Corporate Oversights of Quality and Compliance

Six Corporate Oversights of Quality and Compliance Issues in Pharmaceutical Environments: Benefits of Iterative and Administrative Task Automation
by Caroline Gasson

At a corporate level, quality and compliance management in heavily regulated pharmaceutical environments is a tricky endeavor. After all, success in the areas of quality and compliance can only be achieved when a multitude of variables are controlled and continually maintained. From document control to CAPA control, and from audit to CRO management, quality and compliance, to avoid oversights, requires full attention and/or automation over all pertinent details.

Avoiding Quality and Compliance Oversights
This article presents six significant quality and compliance oversights that pharmaceutical companies may unknowingly propagate or encourage over time.

Corporate Oversight #1: Lack of Investment in CROs

It's no secret that pharmaceutical companies want clinical trials to move faster while simultaneously maintaining high levels of trial accuracy. However, many pharmaceutical companies aren't taking the right steps and/or spending in the right sectors to achieve those goals. Their clinical trial oversights are leading to a common conundrum that is expressed well in an online article1:

"...the outlook is worsening: a drug entering phase I testing in 2000 actually had a lower chance of winning approval than one that began testing in 1985."

The same online article also offers some indirect suggestions regarding CROs (contract research organizations) for clinical trial improvement.

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Utilize CROs
Utilizing CROs can be a great boon to pharmaceutical companies and can speed up product-to-market times while maintaining quality. states the following in regard to the implementation of CROs:

"In recent years, an increasing proportion of resources involved in clinical trials have shifted from the pharmaceutical industry to CROs. According to the Tufts Centre for the Study of Drug Development (CSDD) – which conducted the first independent, third-party examination of the CRO industry's rapid growth – this realignment has increased the speed and efficiency of the pharmaceutical product pipeline, while maintaining high levels of data quality and regulatory compliance.

Among other things, the Tufts study found that trials with significant CRO involvement are more likely to stay on schedule than those with less CRO involvement. Typically, data from such studies were sent to regulators more than 30 days closer to the projected submission date than studies with less CRO participation."2

Clinical trial professionals should also consider investing in technology that allows them to quickly assess their respective CROs and consistently audit the same. The right software solution should also allow users to accomplish the following:

  • Maintain archived audit information and keep track of any outstanding actions
  • Allow personnel to assign a status (e.g. assessed, assessment in progress, approved, etc.) to any given CRO or supplier
  • Organize approval subcategories. (i.e. If a CRO has been approved for the production of x,y, and/or z then the clinical trial personnel will have even more control in their choice of appropriate CROs
  • Improve communication channels between corporate management and CROs

Corporate Oversight #2: Lack of Training for Corporate Personnel
Though most corporations support training at some level it can often be surprisingly inadequate. Take for example some of the top reasons that the U.S. Food and Drug Administration will primarily assign 483 observations:

  • Inadequate Complaint Handling
  • Inadequate Corrective and Preventive Action (CAPA)
  • Inadequate Medical Device Reporting (MDR)
  • Inadequate Documentation for CAPAs
  • Inadequate Validation Procedures
  • Inadequate Quality Audits
  • Inadequate Design Process Control Procedures

All of these "weak spots" could be less-than-perfect for a variety of reasons. Lack of centralization of key quality and compliance information or poor root cause analysis could very well cause glitches in even the most carefully planned quality systems. One may wonder however what it is that contributes to lack of centralized information or poor root cause analysis. In many cases, the problem can be related to training or the lack thereof.

Pharmaceutical corporations should consider more advanced methodologies for quality and compliance training.

This may include a more sophisticated training staff, the control of administrative tasks with learning management software or training consultation.

Corporate Oversight #3: Lack of Investment in Successful Technologies
One of the most serious corporate oversights for quality and compliance is a tendency to "play it safe" without the appropriate technologies. For example, many pharmaceutical companies still manage documents with a manual (i.e. paper-based) system or a hybrid system that literally costs the company hundreds or even thousands of annual administrative work hours. Audit, change control, CAPA, customer complaints and nonconformance identification processes are also often handled manually when there are software solutions that can electronically streamline the administrative aspects of all--or most--quality and compliance processes. One can hardly blame these "suspicious" companies however when one considers the large amount of available quality and compliance technologies and their respective costs. Software solutions designed to streamline processes associated with both quality and compliance can be difficult to select, implement, use, and pay for.

To avoid the "burnout" that often occurs when companies search for automated software solutions, companies need to follow a simple process:

  • Discuss Options with Other Companies - Pharmaceutical companies need to talk with other pharma companies that have implemented automated software solutions and determine whether the same solution(s) would function in their own environment.
  • Carefully Determine ROI – Companies also need to determine the estimated ROI (return on investment) they will achieve with the solution(s) themselves. When calculating ROI, companies should remember to account for the time that will be spent for the installation, configuration, training and deployment of the software solutions. The time required should also be confirmed by the software vendors' clients.

Many corporations also need to consider investing in the technologies that ease the burden of globalized quality and compliance management. Corporations that work with internationally located research and manufacturing contractors should--for example--invest in the technologies that can produce reports in a variety of languages and route those reports on global and local levels.

Corporate Oversight #4: Lack of Understanding and/or Investment in Pharmacovigilance and Pharmacoepidemiology

Pharmacovigilance, or the process of conducting risk assessment during pre- and post-marketing phases of product development is an essential series of processes that every successful pharmaceutical corporation needs to master. Several steps pharmaceutical companies can take to procure the best PV data while analyzing it successfully would include the following:

  • Maintain quality and compliance information relating to global, regional, or local PV audit programs. This information should be stored electronically (for easy access) if possible;
  • Ensure rapid resolution and follow-up of any pharmacovigilance issues. Rapid resolution will require some type of software control;
  • Harmonize PV auditing procedures;
  • Facilitate the handling of PV related regulatory inspections;
  • Provide PV related trending information.

As with other quality and compliance procedures the iterative tasks associated with pharmacovigilance should be automated when possible.

Corporate Oversight #5: Lack of Understanding or Investment in Risk-Based Management

Risk based management is essential to ameliorating the affects or potential affects of nonconformance events that is likely to occur in pharmaceutical environments. According to an online article "...risk management drives the identification of hazards, the risks associated with those hazards, and the probability of nonconformity occurring at the design stage, during production and post-production. Elements of risk management include analysis, evaluation, control and post-production data analysis. Most manufacturers do not have a complete risk management program in place, even though they may have some elements of risk assessment, control and/or a postproduction monitoring systems."3

Pharmaceutical manufacturers and researchers should seriously consider the advice of an online article which states the following:

"The FDA expects a risk management plan (RMP) to follow a basic process of, "(1) learning about and interpreting a product's benefits and risks, (2) designing and implementing interventions to minimize a product's risks, evaluating interventions in light of new knowledge that is acquired over time, and (4) revising interventions when appropriate"."4

The same article also recommends a "risk management paradigm," which includes the following steps:

  • "Identify: Search for and locate risks before they become problems"
  • "Analyze: Transform risk data into decision-making information. Evaluate impact, probability, and timeframe, classify risks, and prioritize risks"
  • "Plan: Translate risk information into decisions and mitigating actions (both present and future) and implement those actions"
  • "Track: Monitor risk indicators and mitigation plans"
  • "Control: Correct for deviations from the risk mitigation plans"
  • "Communicate: Provide information and feedback internal and external to the project on the risk activities, current risks, and emerging risks"5

For the planning, tracking, controlling and communication phases, pharmaceutical companies should consider—once again—a software solution that can more effectively manage and automate these processes.

Corporate Oversight #6: Lack of Necessary Quality and/or Compliance Personnel
Another common corporate oversight is the amount of personnel hired to manage quality and compliance endeavors. For example, many corporations hire liberal amounts of management and administrative personnel while personnel assigned to quality and compliance tasks often remains sparse. Obviously, pharmaceutical companies are seeking to save essential funds by investing in the positions that "really produce" but in most cases pharmaceutical companies are committing the misallocation of funds error. The misallocation occurs when companies continue to invest in manual work processes that could alternately be managed by high ROI software solutions. A portion of the funds saved with a software solution(s) could be used to invest in additional quality and/or compliance personnel positions which in turn can allow your company to achieve better levels of quality and compliance without the 483 headaches and product recalls. If a company does not have the resources to invest in additional QA personnel then the right software solution can also assist a limited QA group in the performance of their required tasks.

The Market Watch website in conjunction with PR Newswire published the following quality to manufacturing ratio of quality-to-manufacturing personnel suggestion:

"Proper staffing of quality roles is just one way organizations optimize their quality function and a study by pharmaceutical benchmarking leader Best Practices, LLC found best-in-class companies have a ratio of quality personnel to total manufacturing employees between 1:4 and 1:7."6

Pharmaceutical companies should also consider increased QA budgets and support. Support for a company's QA team may include/require the following:

  • Increased planning of workload and resources
  • Reduction of paper-based efforts
  • Harmonization of QA groups
  • Reduction of administrative tasks such as response and action follow-ups
  • Encouragement of relationships with QA customers

In regard to the encouragement of relationships with QA customers,

"Steady interaction with regulators," is also recommended by the ngpharma article. The old adage, "the squeaky wheel gets the grease," is certainly applicable in this scenario since persistence pays when it comes to working with large regulatory bodies like the FDA or the EMEA. The article reads as follows in regard to interaction with regulatory bodies:

"Steady interaction with regulators – for example, in representing the CRO industry in quarterly meetings of the EMEA's EudraCT-TIG working group – aims to improve the efficient conduct and oversight of clinical trials, and to foster greater collaboration across stakeholders."

Pharmaceutical companies are pressed for time and pressed to produce. What better advantage could pharmaceutical companies take advantage of than the ability to streamline and automate iterative and administrative tasks.



Caroline Gasson heads QAAD EU Operations for MasterControl, Inc. and was one of the initial founders of AMG IT Systems Ltd. which was acquired by MasterControl in June 2007. Committed to continuous innovation in software solutions for quality groups (especially innovation that enhances quality, functionality and ease-of-use), Caroline provides the overall vision for and direction of the MasterControl QAAD quality management and compliance solution.

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