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Are you Prepared for Software Validation?

12 Sep 2011 0 Comments

For industries that operate in regulated environments, software validation of processes and systems is an important and required part of business. The goal of the software validation process is to provide a high degree of confidence in a process or system by demonstrating consistent and repeatable operational results through documented evidence. The exact requirements of a compliant validation will be detailed by the appropriate regulatory agency that oversees your business sector. If your business uses Good Practices
(GxP) and is in the food, pharmaceutical products, or medical devices business sectors, then you are likely required to comply with a regulatory agency. Failure to comply with regulations could lead to fines, suspension of business, or even loss of your business. This article will provide an overview of a software validation for a computer software system to be compliant with Food and Drug Administration (FDA) regulations.

Computer software can be employed within an organization to gain efficiency or perform functions that are specialized. Software can consolidate data and make data analysis more effective or flexible. For all of the positive things software can provide, it is not a magic bullet that will solve problems without understanding the requirements for obtaining the desired results. Understanding the scope and requirements of processes that the software will be employed is the first step in executing a successful software validation.

Gathering requirements is a critical step for implementation of software. Documentation of features and functions will provide the validation process with the information needed to develop the appropriate test scripts that will demonstrate all requirements are satisfied. Within the requirement phase, the documents produced will include:

Feature Request Specification (FRS) / Business Process Analysis (BPA)

This is step provides the high level overview of all processes for which the intended software solution will cover. If the software will replace manual processes, then examples of the manual process should be included. When no manual process already exists, a map of the intended process should be developed. The software scope is defined and the type of software solution is determined. The type of software could be a commercial off the shelf (COTS) solution or a custom development solution.

Software Requirement Specifications (SRS)

Whether the software solution selected is custom or COTS, the SRS will detail each feature and function required from the processes or procedures defined in the FRS or BPA. Each statement within the SRS is written in precise and explicit language such that it will become a testable item for the validation process. Approval by all appropriate parties is required and once the SRS has been signed, no changes can be made to the signed version. Subsequent versions of the SRS require the re-execution of the approval and validation cycle.

The SRS is one of the most important documents within the software implementation process. It becomes the blueprint with which all validation results will refer back to.

Software Design Specifications (SDS)

When custom software development is required, the SDS document provides the development plan for the software code. This document will detail the technology, development tools, software architecture and parameters to be implemented in the software code during the development of the software solution.

Software development and Installation

Once you have the above requirement phase complete, you should have the roadmap for the tasks required to reach the goal of system installation. Timelines developed from the requirement documentation will account for all development, testing and installation of the software solution. During this cycle, all changes and deviations need to be recorded and updated in the documentation with appropriate approval steps followed.

Custom development systems will require the development of installation and configuration procedures and documentation. If the software system is a COTS system, the vendor will need to provide you with concise and complete documentation for installation and configuration of the software. These documents will accompany the System Configuration Specifications (SCS) document. The SCS captures all software installation/configuration, hardware, network, and environment details. The purpose of the SCS is in part for disaster recovery planning.

Validation Preparation

Validation personnel should be consulted during the requirement and development phase of the project. During this time, validation personnel can begin preparation and planning for the validation testing, but test script development will be limited until a development environment has been installed with the software system. Once a full development environment has been setup, the validation team can engage directly in preparing the required validation documentation. The documentation produced in this phase will include:

Installation Qualification (IQ)

The IQ document is a set of test scripts used to verify that all software and equipment has been installed correctly and meets the specifications defined in the SRS. The development of the test scripts will determine if all installation and configuration instructions have been executed and followed as written, thus it is important that there are no ambiguous parameters or instructions contained within the installation documentation or SCS. If the installation instruction provides alternative configuration methods, the specific configuration will be defined by the SCS. The IQ testing is limited to the static attributes of the system and subsystems prior to operation.

Operational Qualification (OQ)

The OQ document is a set of test scripts used to verify that the operation of features and functions within the software system meet the specifications defined in the SRS. These test scripts will target not only specific function and feature, but also will test processes, security, and data integrity. Each test will relate to one or more SRS items.

Performance Qualification (PQ)

The PQ document is a set of test scripts used to verify that the expected daily performance is acceptable. These test scripts verify that the system will give consistent results under load and predetermine SRS criteria.

User Acceptance Test (UAT)

The UAT is a set of test scripts used to verify the intended daily operation of the system within your environment. These tests will closely mimic the procedures and processes executed during the course of regular business operations.

Reverse Tractability Matrix (RTM)

The RTM provides the direct links between the SRS and IQ/OQ/PQ/UAT tests. For each SRS item, the validation test scripts that verify the expected result are listed. This provides any party involved the ability to audit the validation results and determine if all expectation of the software have been satisfied.

Standard Operating Procedure (SOP)

The Standard Operating Procedures will be a set of documents detailing the steps and procedures required in the operation, maintenance, backup and recovery of the software system. These documents also specify who is responsible for tasks and when actions are to be performed. The SOPs are not exclusive to the software system. The SOPs generated here are part of the entire company Standard Operating Procedures.The software validation documents prepared will need to be dry run by quality assurance personnel to verify that the test scripts execute cleanly. Language is an important component of the test scripts. Dry runs will
identify any ambiguous instructions and mistakes within the test scripts. At the point where all the validation documentation has been verified, all documents will be versioned, approved and signed by the responsible parties involved. Once this has occurred, no further changes can be made to documents without repeating the approval process on any change. The approval of validation documents is required before execution of validation can begin.

Now it’s Time to Validate

The install processes developed above are executed to create a testing environment for the software system. The quality assurance personnel will execute the validation plan, recording all results and deviations. On completion of validation process within the testing environment, all documentation will be signed and approved with all exceptions and deviations accounted for.

Provided there are no deviations or exceptions recorded that violate compliance regulations, the production environment can be installed and validated. The production environment will follow the same procedure as the testing environment.

Acceptance

After all validation documents have been executed without any unacceptable deviation or exceptions, the final acceptance of the system can be done. The acceptance criteria for the completion of system testing will include:

  • Successful completion of the testing developed according to the Validation Plan for each test component.
  • Approval of all test documents for each test component.
  • All SRS requirements have been verified in the working test and production systems.
  • Proper recording of any reported variances and appropriate corrective actions for closure applied to each variance.
  • Assurance that the number and/or nature of reported variances for each test component do not compromise the intent or integrity of the software implementation as determined by test document post reviewers.

After the system has been accepted, you will need to train personnel for daily operations. Along with training, the SOPs will be implemented and official release of the system is required.

Conclusion

The validation process provides the evidence required to prove that a system or process operates as designed and complies with any industry regulations. Validation also provides you with a greater depth of understanding about your systems or processes. If your validation has been well designed, it has greater benefits than just being compliant; it can also provide a greater level of control to your business. The documents described above are part of a living process. Any software updates or patches require validation that will follow updates to initial validation plan. These subsequent validation cycles may be scaled down from the initial validation, but the result will extend the unbroken historical line of the system or process.


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Why Use Technology For Your Courier Business

12 Sep 2011 0 Comments

Couriers who transport such items as medical specimens face special challenges. Organizations such as clinical laboratories, blood banks, biomedical services, hospitals, pharmaceutical services, and tissue banks depend upon couriers to transport medical specimens safely and track time critical delivery. Because of today’s mobile technology, clients can track individual packages in real time and validate deliveries, especially critical in life or death scenarios.


For companies offering time critical services, the ability to access information and packages quickly can result in time and labor savings and improve customer satisfaction. For some clients, efficient time critical service is truly a matter of life and death.

In addition to changes in devices used by drivers, highly sophisticated warehouse management solutions can have a tremendous impact on the business, allowing for reduced warehouse space due to increased efficiency, less labor, carrier freight savings and improved overall service.

The benefits of using current technology for your courier business:

  • Delivery confirmation signatures can be captured, stored, transmitted and reported electronically.
  • Using handheld devices saves time and reduces labor costs
  • Electronic information can be stored in formats that can be readily searched and reported, saving on labor and clerical costs.
  • Using software and handheld devices increases accuracy, reducing the incidence of costly, time consuming errors.
  • Employing technological solutions allows for real time tracking of information.
  • Use of electronic data makes information easy to reconcile, track and implement in producing reports
  • Removing the paper trail reduces paper waste, saving trees and other resources.
  • Use of warehouse management system software enables a business to organize, schedule and monitor critical warehouse functions, increasing efficiency in order to save time and money.
  • Using transportation management system software enables the business to streamline transportation routes, collect, organize and monitor data on drivers, deliveries and transportation resources. The streamlined business can reduce energy costs and other expenses.

Overall, the correct use of today’s courier business technology can help to reduce errors, save time and money and develop more efficient, consistent business practices. These streamlined operations often are more productive and profitable. In addition, having access to accurate real time data and information provides the opportunity to communicate clearly with customers, potentially increasing the level of service, support and customer satisfaction.

Technology currently available for your courier business

  • Barcode scanners create business efficiency by recording information about packages, enabling them to be tracked throughout the warehouse and delivery processes. This ability to track packages is essential to meeting expectations and regulations.
  • Warehouse management software solutions help to organize the storage, retrieval and processing of packages and inventory, as well as to produce useful, critical reports and provide visibility for customers and employees.
  • Transportation management software solutions produce effective information tracking of drivers, deliveries, routes and other critical information.
  • Radio frequency (RF) facilitates the use of handheld devices in warehouses, allowing for the transmission of information from point to point, reducing labor expense.
  • Handheld computers capture signatures electronically, allowing the data to be transmitted, stored, tracked and reported for a variety of functional uses.
  • Global positioning systems (GPS) technology is essential in tracking packages, deliveries and drivers throughout the logistics and delivery processes.

How to find effective technology solutions for your business

  • Contact a company that has experience in dealing with companies in the courier industry and is a member in good standing of courier associations, such as MCAA and ECA as well as FMA and other state courier business associations.
  • Look for a single source supplier of technology. Ideally, your business should be able to contact one company from which to purchase handheld devices which are already configured. This company should be available for consultation, service and support and be knowledgeable about selecting hardware to meet the specific challenges faced by your business and its users.
  • Seek a company that has experience in dealing with warehouses, third party logistics providers, transportation professionals, and supply chain/logistics providers. This experience is essential in helping you to locate solutions that will benefit your business while applying best practices to minimize inefficiency and waste.
  • Contact hardware manufacturers such as Motorola, Honeywell and AT&T for recommendations and company references.
  • Find a company that comes highly recommended by other businesses in the courier industry.
  • Information can be found by searching user groups and forum on LinkedIn, the professional social media network.

How a Warehouse Management System (WMS) Can Benefit Your Courier Business

  • Improved customer service: through the enhanced ability to provide accurate, timely information and facilitate more efficient package storage, processing and delivery, the warehouse management team can better communicate with customers and meet customer needs and delivery expectations.
  • Speed of inventory management and control: using RF scanning in combination with a wms allows for improved productivity, streamlined operations and a potential reduction in equipment requirements. Real time tracking ability and the ease of task management allows for tasks to be changed smoothly, making changes in priority relatively fluid.
  • Increased visibility: using a wms system can produce the ability to locate inventory and packages quickly and give vital information needed to make business and operational decisions.
  • Maximized space utilization: by continually managing the location of packages and inventory meticulously, a warehouse management system ensures that warehouse space is used as efficiently as possible, often reducing the need for additional space or off-site storage.
  • Reduced labor cost and dependence upon warehouse personnel: by optimizing productivity through streamlined operations, labor costs and errors are reduced.

The days of using extensive warehouse labor to store, process and locate packages in warehouses are now past. Supply chain efficiency is now a business necessity, demanding that technology provide solutions to complex logistic and operational challenges streamline processes and operations and increase both efficiency and productivity. As consumers have become familiar with the advantages of technology through their ready adoption of sophisticated mobile phones, handheld devices and games, they expect technology to be used in businesses and depend upon it for real time information and service. Courier businesses which utilize technology benefit from reduced expenses are able to satisfy customer expectations and build stronger, more profitable businesses.

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Adopting New WMS Business Technology

12 Sep 2011 0 Comments

Even though the Einstein quote is well known, far too often we go about our daily wms business doing the same things over and over and expecting different results. Many companies don’t realize that what made them competitive five years ago may be the very thing that’s holding them back now. Technology and process development continue the move forward. That proverbial wheel keeps turning out system enhancements targeted to increase productivity, efficiency, visibility, customer service, ease and flexibility. In order for a business within the supply chain to use technology as a competitive advantage, it is essential to reassess both your system and process at a minimum of every 2 to 3 years.

In the last 5 years no ground breaking hardware technology like the computer or cellular phone has been introduced. No new paradigm that fundamentally changed the game like the Internet. Yet the rate of change has not slowed, if anything it’s increased. The Internet may not be new, but through the emergence of social media, the way we interact and benefit from it is. Does your web page still say “Under Construction?” If your technology and processes are more than five years old, how can they possible accommodate new WMS business drivers that didn’t exist when the solution was implemented?
Now you may ask yourself what is the concern if my system continues to work for me, my team and my customers. The real question is “how long will it continue to work?” We are emerging from a time of  great shrinkage and stock elimination, when logistics slowed to a crawl. Have you failed to review your system because it was fine or perhaps just fine for now?

Recent studies have proven that most customers invest in technology solutions to meet the following criteria:

  • Support corporate growth
  • Improve customer service
  • Increase return on investment
  • Provide a competitive advantage

Some warehouse management software systems that are more than 5 years old can hinder your WMS business progress more than they can help. Keeping in mind the top 4 technology investment criteria mentioned above, as time moves forward and technology advances, a change is often more practical to achieve these goals.

Constantly fixing or tweaking your existing systems is like fixing your five year old cellular phone. You can make in and out calls and add on extra features from your provider but at the end of the day you’re still left with an old phone that can’t perform and simplify the way the latest technology can. There’s nothing more frustrating than watching your peers utilizing the latest mobility, communication, and productivity features of a smart phone with ease, especially when they paid less now than you paid 5 years ago and their maintenance is similar to or less than yours. Sometimes you just have to make the change.

Fear Factor

Intimidation plays a big roll – Accepting change is never easy. Sometimes we get into a comfort zone with what we’ve already got. You’re aware of the costs incurred 5 years ago and the aversion to change you had to overcome to roll out a new system. Now you see a fancy new system with all the bells and whistles and it’s intimidating to look and hard to believe that it could be within your budget, scope, grasp, and reality.

Consider these questions:

  • Is your software vendor’s strategy still in-line with your company’s goals and objectives?
  • Can your needs be met by simply re-configuring your system or does your provider have to rewrite or code enhancements to meet your needs and will this effect bringing on new WMS business?
  • Are your systems integrated or do you have to re-enter data between systems?
  • Does you technology give you an advantage over your competition or do your customers ask for service only your competition is providing?
  • Are you able to use the latest technologies, processes, and standards such as real-time, activity-based management, automated processes, workflows, and customer visibility into inventory?
  • Is your system compliant with the latest government requirements and documentation?

Which are you more afraid of, implementing or fixing a system, or not doing anything at all?

Call to Action

This first step to solving a problem is recognizing the problem. Before the economic recovery strains your system, take a long hard look at the process you have in place and see if your system is supporting or interfering with your WMS business. Make repairs while you have the extra resources to fix the problem and test new solutions, not when you are under pressure to perform. This will ensure that as new business and customer requirements come your way, you can easily adapt and keep your profits. While the economy is still soft, you can typically receive more flexibility from vendors who are also feeling the pinch, especially for soft services like a warehouse mangagement system business analysis or site survey. If you wait too long, you’ll be competing with all the other businesses that waited until the situation reached a critical stage. Not only will vendors be less likely to make deals, they’ll also have less flexibility in terms of scheduling and you may find yourself waiting at a time when you can least afford to – when you are losing money.

Now ask yourself, “If I always do what I’ve always done …”

Special thanks to Datex solutions consultants Norbert Altenstad and Nick Mazeika for consultation on the construction of this document.

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