How to Reduce the Burden of Validation Documentation by Using Lean Documentation and Risk Assessment Best Practices

Despite the criticality of Computer Systems Validation (CSV) and its related regulations on data integrity, such as 21 CFR and Annex 11; perhaps no company seems to be happy at the prospect of carrying out validation. Why is this so? It is because most companies that have reservations about validating computer systems in accordance with 21 CFR and Annex 11 don’t realize its importance.


Many organizations and regulatory professionals show resistance to CSV because they believe that this is a time-consuming and expensive exercise. Many believe that implementing CSV retards the deployment of many features and functions that could accelerate the organization’s business growth. Nothing is farther to the truth than this.

Patchwork solutions

It is a misconception that solutions such as commercial off-the-shelf (COTS) systems solve the issues relating to cost and productivity. COTS is at best an ad-hoc solution that is bought and installed on servers internally and then configured to suit the company’s corporate network and with other systems and databases and then used to manage it according to the company’s IT strategy and its SOPs. So, what is wrong with this system?

CSV-processNothing, except that when a company opts for COTS, the COTS vendor supplies only the COTS software package, which still leaves everything other than it with the ownership, management and maintenance by the company. The company still incurs significant costs on critical areas such as maintenance, administering the internal network connections, securing the data, creating disaster recovery contingencies and keeping the required hardware viable, which is very capital-intensive.

Most companies don’t realize that it is this, and not proper CSV, which slows down business functionality. This arrangement, with its inherently slow pace of deployment and functionality, keeps burgeoning, even as the resources needed for its implementation keep becoming lean, becoming inadequate to meeting business needs.

And what about the humongous blunder of documentation? This adds greater burden and could require redoing the whole thing if something goes wrong somewhere. In addition, most vendors use current technologies such as the cloud. Here, the vendor is in partial to near-total control. The automation techniques the vendor would use to update features and functions could sometimes clash with the current validation processes.

The solution

The solution is to get clarity on how to meet the same level of Quality that complying with regulations and GAMP 5 ensures, while taking advantage of technologies such as cloud and SaaS implementations, and to keep abreast of the latest technologies while ensuring the quality of computer systems and that they are “built to regulations” to achieve Data Integrity.

All aspects of validation explained

At this hands-on seminar, Angela will describe how the participants can speed up validation that is current in keeping up with recent technologies while still implementing a rigorous computerized system compliance program. She will show how to use the methodology enhancers of risk management, lean documentation and automated testing for ensuring this. She will explain how companies can achieve rigorous compliance, build computerized systems to regulations and use techniques that reduce the validation effort.

Also splashed into this seminar is a set of exercises that includes a project which the attendees are currently working on. Angela will also bring in a Jeopardy style quiz to test the attendees’ knowledge, and to also ensure maximum retention of the concepts and practices.

As a result of the learning gained at this seminar, attendees will be able to:

  • Master the principles and regulations that achieve data integrity by applying the 21 CFR 11/Annex 11 and GAMP 5 validation of computerized systems regulations to computerized systems
  • Explain how to reduce the burden of validation documentation by using Lean Documentation & Risk Assessment Best Practices while still fully complying with regulations and achieving data integrity
  • Explain automated testing best practices how to select automated testing vendors to ensure that use of vendor tools allows for the flexibility to use Cloud/SaaS/IaaS/PaaS related technologies while maintaining data integrity
  • Explain how to use Hardware Qualification and Change Control to manage both internal network and infrastructure as well as vendors such as cloud providers.

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What Happens When Your Product Is Detained by the FDA?

What happens when your product is detained by the FDA? In short and simple words, a nightmare. If you thought that the FDA Compliance had always been strict in its enforcement of import rules, you would think again if you heard about what it has worked out lately.

Import Rules for FDA Imports1

The FDA has partnered with the Customs and Border Patrol Service (CBP) to put in place a sophisticated and agile method by which it can monitor the information it requires from importing firms, and also ensure their adherence to government procedures. The CBP has created a novel mechanism to intensify vigilance of imports, called the Automated Commercial Environment (ACE). This computer program has brought in many changes into import logistics and the method by which importing firms have to report information pertaining to FDA-regulated products.

So, what powers do the FDA and the CBP have by implementing the ACE? They have powers of delaying, detaining or refusing shipments of firms that fail to put in place a thoroughly executed import and export program. Importing firms that believe they can take this mechanism easily could not be more mistaken: noncompliance with the requirements set out by the ACE program empowers the FDA and the CBP to stop a shipment before it is even loaded at the point of origin, even if it is a foreign port. A ship that wants to be precluded from the ACE program attracts a fine of up to $10,000 for every offense. Alternately, if the FDA detains a product or products from such a company; it will start a long drawn out and costly legal process.

Import Rules for FDA Imports2

Since the agency expects companies to have the import coding information accurate and up-to-date; companies that do not have a clear understanding of the automated and human review process are very likely to have their shipments detained.

Another scenario

What happens to an importer whose product is deemed fit for release and to be brought back to the port of entry by the FDA, but the importer cannot locate the product that is already sold? On such companies, the FDA slaps a fine whose value is treble that of the shipment! And this is not all. This in no way waives the other usual legal actions that the FDA will initiate anyway.

Not everything is bleak

All this should not intimidate and put importers off. Alongside the ACE program, the FDA has also put in place a redressal mechanism under its Food Safety and Modernization Act. Called the Voluntary Qualification Importer Program, this FDA-monitored program is aimed at smoothening the review and import of food items from importers who can show the agency that they are serious about implementing a higher degree of control over the safety and supply chain elements of the food items they are importing. Those Importers who are serious about the quality of food they import.

The FDA also offers export certificates, which could give an importer a level of advantage in foreign markets. Also available for a fee, albeit a small one, an FDA export certificate is a shot in the arm for importers, because this certificate is required in some markets.

Familiarize yourself with all parts of FDA import rules for 2018

GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering complete learning on all aspects of the FDA import rules for 2018 at a two-day seminar. The Director of this seminar on FDA import rules for 2018 is Casper Uldriks, an ex-FDA Expert and former Associate Center Director of CDRH, Olsson, who has served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

The full expanse of Casper’s many years of experience will be exhibited at this valuable seminar. He will show how to steer clear of the many common potholes and constraints that importers who don’t have a sound strategy run into. Participants will be offered tips on how importers need to put in place an established and effective business plan.

This course is of immense value to domestic importers, foreign exporters, initial importers, international trade executives, Venture Capitalists, marine insurance underwriters, import brokers, Regulatory Affairs managers, import/export consultants, in-house counsel, contract specialists, logistics managers, third party establishment inspection entities, sales managers, and investors.

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Are Your IT Systems GxP/GMP Compliant?

How does Sarbanes-Oxley affect the accounting profession?

The Sarbanes Oxley Act, or what is more popularly called SOX, was enacted by President George Bush in July, 2002. This law was passed in response to the discovery of monumental scandals of many leading American organizations, whose managements exploited the loopholes in accounting practices to carry out huge financial frauds.

While the SOX Act is primarily aimed at making managements more accountable in their financial management practices, because of which the managements have had to make major changes into their financial reporting practices; another profession that has been impacted in a major way by the passage of the Sarbanes Oxley Act is the accounting profession. This is because of the fact that while management has to show greater transparency; it is the professionals in the accounting profession who have to actually carry out these changes and present them to the concerned authorities. This requires them to implement a number of major changes into their accounting and reporting practices.

Change at the most basic level


At the most basic level, the nature of work of accountants has undergone a major change. They are now required to orient their work a lot more towards ensuring diligence in the bookkeeping practices than they were used to. Restoring confidence in the public and with the financial institutions and the government, as well as with the investor community, has become a very high priority for accountants. It signals a new orientation in their careers.

On the administrative side, the Sarbanes Oxley Act makes significant changes into the accounting profession. Making CEO’s and CFO’s responsible for the authenticity of financial statement and requiring them to certify the veracity of accounting statements; SOX established the watchdog, the Public Company Accounting Oversight Board (PCAOB). On this board, two CPA’s are required to sit, along with three other people who are not necessarily qualified as highly, but are expected to have fluency in the workings of financial systems.

Clipping many functions 


More importantly, Sarbanes Oxley affects the accounting profession in more profound ways, because this Act has clipped many of their traditional supplementary functions. Sarbanes Oxley prohibits accountants from three major activities with a publicly listed company that comes under the purview of the Sarbanes Oxley Act:


Many of accountants’ functions pruned

Sarbanes Oxley affects the accounting profession in more ways. Based on the apprehension that auditors might influence financial decisions from managements by promoting a few services; Sarbanes Oxley bars accounting firms from implementing a client’s information system. They cannot also provide advice on investment, and they cannot advice managements on banking services and management services.

This requirement clips the wings of the accounting profession, whose bouquet of services has now got substantially reduced. They can help with tax preparation along with some allied services, but will have to do so only after getting approval from the board. In this way, Sarbanes Oxley affects the accounting profession by barring it from carrying out a variety of activities that were considered fluffy and auxiliary.

The accounting profession has to now be on its toes all the time – Read more


New Food Labeling Regulation in Canada

In late 2016, Canada introduced new changes to its food labeling regulation, which does away with the existing one, the Guide to Food Labelling and Advertising. Codified under what is called the Industry Labelling Tool; this regulation tool provides guidance to a number of important aspects of food, such as:

  • Food Products that Require a Label
  • General Principles for Labelling and Advertising
  • Labelling Requirements Checklist

Aim of the new food labeling regulation in Canada 

The main aim of the new food labeling regulation in Canada is to make it easier for consumers to understand the nutrition information more easily and make informed choices about the food they consume.


It also seeks to bring safer food for the country’s children by making changes into the labels of food meant for children. Towards this, it will continue to implement the recommendations the World Health Organization passed in 2010 to ensure safer food and beverages for children.

At the time of passing the new food labeling regulation in Canada; the WHO guideline was being implemented vigorously in Quebec for children below the age of 13.

How is the new food labeling regulation in Canada being implemented?

The new food labeling regulation in Canada, which was enacted in late 2016, expects the designated industries to implement the guidelines set out in the Industry Labelling Tool over a five-year period. Some of the amendments that come up for the earliest phase of implementation cover the food color specifications and the removal of synthetic color specification. The implementation of these amendments has started in early 2017. Consultations have been going on with food experts, stakeholders, the industry and the general public.

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Concerned about health and safety on the job?


Are you one of those concerned about health and safety on the job? You’re not alone. Across the length and breadth of the US, the millions of workers who are employed in the various sectors, be it manufacturing or services, or technological or agricultural, are prone to injury at the workplace. Not one kind of job or working condition or employment or workplace is free from the potential to cause injuries or illnesses. This is why there is every reason to be concerned about health and safety on the job.

Concerned-about-Health-and-Safety-on-the-JobYet, there are a good number of security safeguards that have been put in place in the form of legislations from the Occupational Safety and Health Administration (OSHA). OSHA has been primarily enacted with the purpose of giving employees rights to a safe workplace. Why every employee needs to be concerned about health and safety on the job is best answered by these disconcerting statistics:


OSHA is about dispelling concerns about health and safety on the jobConsidering the damage that concerns about health and safety on the job can cause to the workforce as well as to the economy, the US legislated OSHA way back in December 1970. The main intention of this historic piece of legislation was to ensure safety of workers at the workplace not just through suggestions, but through actionable steps.

Concerned-about-Health-and-Safety-on-the-JobThe hallmark of this legislation is that it empowers employees to demand a safe workplace. If an employer is seen to be violating the provisions of OSHA or if the employee feels that there is some form of potential danger to her physical wellbeing at the workplace; she has the right to complain to OSHA without fear of being retaliated against.

A host of rights to assuage concerns about health and safety on the jobAmong the main features of OSHA is that it requires the employer to publish employee rights about their safety at the workplace. This enables them to allay concerns about health and safety on the job, as they have a ready reference to which they can go back in case of a doubt about the implementation aspects of any provision of OSHA. Employees who are concerned about health and safety on the job have the following rights:


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Risk Management in the Global Economy and outlook for 2017

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Risk management in the global economy is a highly challenging field for risk managers from any part of the world. With most of the world’s countries almost becoming part of the global economy in this era of globalization; it is emerging that risks that apply to one part any one nation’s or group of nations’ economy could affect many more in a chain reaction, or domino effect.

The Judge Business School of Cambridge University, in its estimate for risk management in the global economy for 2017, has a rather bleak outlook for the global economy. The report analyzes that no fewer than 25 dozen of the world’s urban centers could face close to two dozen different kinds of major shocks of primarily an economic and also of a political and social nature.

risk-management-in-global-economy-and-outlookThis is going to likely impact these important nodal cities of the global economy to the extent that the world’s GDP is going to shrink by as much as 1.5% percent till 2019. This translates to something in the order of $ 1.2 trillion.

Factors determining risk management in the global economy in 2017The report pins down a few important factors that have contributed to the need for risk management in the global economy in 2017:

    • The world is producing more than it ever did in its history. This is because of the high level of human population, which is the highest ever recorded in history, and the economic, agricultural and industrial growth of many underdeveloped economies
    • There has been an unprecedented increase in crises and disruptions in the geopolitical, financial and technological fronts, making risk management in the global economy for 2017 an important area to be addressed by the political and financial leaders around the world


  • The financial sector has come under greater strain in the past few years following the slowdown of 2008 than it had in the few preceding ones, making the prospect of a global meltdown any time in the future a possibility, if not a certainty
  • Added to these, risk management in the global economy for 2017, like in any other year, does face prospects that are of a natural order, such as natural disasters and wars.
Global economy will bear the brunt

risk-management-in-global-economy-and-outlookAll these factors would not have had the same impact as they are likely to have in the current scenario and in the immediate and intermediate future, if not for globalization. The world’s shift towards globalization is now certain and irreversible. The interconnected nature of the global economy has ensured that a shock in one part of the global economy is sure to cause ripples of either a minor or major nature in any other part.

Other important factors for risk management in the global economy in 2017risk-management-in-global-economy-and-outlook

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An understanding of Risk Management and Analysis for Medical Device Manufacturers

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Risk management and analysis for medical device manufacturers is an essential set of approaches to quality in the field of medical devices. Implementing these is of absolute importance and criticality to the field, as the products in this industry are high-specialty ones that deal with human lives. A small error at any stage can send the product, and with it, the reputation of the manufacturer and even the healthcare provider, into a tailspin.

From its beginnings a few decades ago as a “nice to have” feature or discipline that used to come into the picture only when there were issues; quality has grown into an indispensable element of a medical device product. A medical device product into which quality does not get intertwined at every stage, right from procurement of the raw material to the use it is put to by the consumer and beyond, is unthinkable today.

risk-management-and-analysis-for-medical-device--manufacturersThe primary driver of this metamorphosis is risk management. Risk management and analysis for medical device manufacturers has been the lynchpin among the agents of change brought about into this field. Quality has evolved as a result of the change in the import regime in the US in the seventies, when products from around the world used to deluge the US market.

the consequences of this trade policy have led to the emergence of the creation of quality approaches such as Six Sigma and kaizen among many others, and global standards, of which ISO 14971 specifically relates to Quality Management Systems and methods for medical devices. Root Cause Analysis is at the root of each of these methodologies and standards.

So, what is risk management and analysis for medical device manufacturers?

risk-management-and-analysis-for-medical-device--manufacturersIn the context of medical devices, risk management and analysis for medical device manufacturers means applying a set of processes, policies, methods and practices into their manufacturing systems in alignment with respective and relevant standards as set out by global standards such as the ISO. The aim of these standards and practices is to analyze, assess, control and monitor risk. The ISO 14971 has been revised many times and each time this is done, the latest one becomes the extant version. This and other standards and practices prescribe steps and processes that need to be implemented at all stages of the product lifecycle.

The need for risk management and analysis for medical device manufacturersThe need for risk management and analysis for medical device manufacturers is simple: To ensure that the medical device meets quality requirements and is manufactured according to standards and specifications and methods prescribed in these standards. Standards such as ISO 13485, various Quality Systems Regulations (QSRs) such as 21 CFR 820 and a few European standards work in tandem with ISO 14971. The core purpose of requiring medical devices manufacturers to meet these requirements is to ensure that safety and quality are built into a medical device from start to finish.

The time at which to carry out risk management and analysis for medical device manufacturers

risk-management-and-analysis-for-medical-device--manufacturersRisk management and analysis for medical device manufacturers is to be carried throughout the lifecycle of the medical device. A set purpose is set out at each stage of the manufacturing process. For example, medical device manufacturers are required to identify and eliminate potential hazards at the initial stage using the concepts of product optimization, and use the principles of risk elimination at all the next stages, and to use the methods prescribed during a product recall.

The ways of carrying out risk management and analysis for medical device manufacturersThe ways by which risk management and analysis for medical device manufacturers are to be exercised form an important part of quality. The ISO 14971 standard is pretty flexible in this regard, allowing the manufacturer to adapt any existing standard or approach that he thinks is best suited for his organization.

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