Twelve Signs that It’s Time to Change Your Business Process

Efficient business processes employ modern information technology to operate quickly, consistently and securely, automatically collecting data and converting it into information with minimal manual intervention, especially from skilled professionals who have better things to do. The following 12 signs indicate that your business process needs improvement:

1. You employ spreadsheets or paper forms, sometimes with multiple copies in multiple locations.

2. You print documents for "wet" approval signatures.

3. You train your people in the "quirks" of the process--and they still ask experts for help.

4. Your SOPs do not describe the real process.

5. You spend lots of time handling "exceptions" and "work arounds" that the automated system cannot handle.

6. You are not sure where to find the correct versions of spreadsheets and paper documents for auditing--and, even then, can't find an audit trail.

7. You manually transfer data from one automated system to another.

8. You manually consolidate data for reports or to support management decisions.

9. You employ "data managers."

10. You use personal technology to get your job done.

11. It is not always clear who has what authority or who is responsible for what.

12. You feel like you are serving the system instead of the system serving you.

Your team might not complain about the time they waste locating and updating paper forms, replacing outdated information, replicating and filing documents, tracking lost documents, etc. Why? Because that "that's the way it is." They will do the best job they can with the resources they have. It might take some probing to discover the true state of affairs, but once your team realizes that you really want to help them achieve their objectives, their minds will open up with a flood of creative ideas to improve cost, quality and timeliness. Without all the wasteful activity, your staff can get their important work done without the stress or long hours.

Learn how VACAVA can help your organization. Contact me today at tbird@vacava.com or visit www.vacava.com/healthcare.

VACAVA. Inc.

VACAVA's mission is to deliver high-quality, affordable custom applications that allow companies to reengineer their existing processes and operate more efficiently and effectively. VACAVA's solutions are tailored exactly to the needs of the organization, allowing us to work with companies of all sizes, from fledgling ventures to Fortune 500 companies.

This article was originally published in the February 2016 edition of the Journal of Clinical Research Best Practices at firstclinical.com/journal/contents.html

Lab Certification Management consuming you? See how a major healthcare organization streamlined their process

Lab certification management can be difficult and time-consuming for organizations. Maintaining certifications and accreditations that provide proof of meeting standards like the Clinical Laboratory Improvement Amendments (CLIA), the College of American Pathologists (CAP) and the Commission on Office Laboratory Accreditation (COLA), is key to the success of clinical laboratory operations.

Managing the documentation and deadlines for these certifications and accreditations can be complex for large networks spanning multiple states, as continually monitoring deadlines and submission details is time consuming. In a fast-paced lab environment, keeping up to date with the changes is challenging and may result in missed updates, especially if an organization has no automated or centralized way of managing information. This can lead to issues with the accurate completion of certification applications and cost your organization money.

Recently, a major Minnesota healthcare provider realized the value of changing their process for lab certification and accreditation management. With 190 labs running over 2 million tests per year, the provider's process of manually tracking certificate completion, maintenance and expiration dates in a spreadsheet was challenging.

Collaborating with VACAVA Inc., a custom solution provider, they designed and implemented a software application which simplifies data collection, management and access. The cloud implementation enabled remote data entry in a real-time sharing environment and introduced features such as certification renewal notifications, compliance reports, profile management, certificate archiving and automated certification and accreditation form population. This new solution has enabled the provider to reduce their management cost and increase efficiency. Now, one employee (FTE) manages lab compliance and accreditation for all 190 labs in the provider's network.

This software application, developed in collaboration with one of the world's most respected healthcare organizations, is now available to organizations of all sizes at an affordable price. VACAVA's LabRight Certification is a tool for busy lab professionals, enabling greater efficiency and lower cost management of lab certifications and accreditations.

Want to learn more about VACAVA's LabRight Certification and the benefits it can offer you? Visit www.vacava.com/labright.

How to make clinical trial regulatory document management easier

Managing clinical trial regulatory documentation is time-consuming and complex for organizations, but is required for success in the field. In the medical research industry, operating clinical trials with greater efficiency, higher quality and lower cost is key. How you manage the essential documents associated within the research cycle can make a surprising difference in the efficiency of your operation.

Recently, a leading cancer center recognized an opportunity to dramatically reduce management complexity and cost by transforming their clinical trial regulatory document process. This comprehensive cancer center offers its patients opportunities to participate in more than 500 clinical trials at a multitude of locations across the country.

Previously, regulatory documentation was managed using shared server files and spreadsheets, which created numerous inefficiencies in the updating process. Because all the data was associated with a specific trial, content changes that affected multiple trials such as physician participation updates, expired medical licenses and laboratory certifications required manually replicating the documents across all the trials. Making all of the required regulatory documentation available for monitors and auditors was problematic and time consuming for both the staff providing the documents and the monitors and auditors reviewing them.

Now, this major healthcare player has simplified its clinical trial regulatory documents collection, management and access by collaborating with VACAVA, Inc. to design and implement an affordable custom application. Developed for the specific needs of medical research organizations, this application has enabled the institution to transform its process and dramatically reduce management complexity and cost.

Web-based forms have replaced paper documents, and are significantly easier to manage. All signatures are collected electronically, and rather than multiples versions of the same document floating around, all necessary forms are collated in one place online. Via the cloud, collaborators can view regulatory documents remotely, which makes the review process more seamless for monitors and auditors.

How can VACAVA help your organization reduce complexity and cost? Contact me today.

About VACAVA Inc.

VACAVA's mission is to deliver high-quality, affordable custom applications that allow companies to reengineer their existing processes and operate more efficiently and effectively. VACAVA's solutions are tailored exactly to the needs of the organization, allowing it to work with companies of all sizes, from fledgling ventures to Fortune 500 companies.

Regulatory Document Management Strategies

Precise regulatory documentation is an imperative in the healthcare industry. The sheer amount of paperwork and detailed tracking required for regulatory compliance can be daunting and costly. A well thought out automated document strategy can ease minds, facilitate audits and make a surprising difference in the efficiency of your operation.

Regulatory documentation often comes in paper forms that are copied and placed in numerous locations, approved by multiple individuals, and audited manually. Regulatory data may be collected and accessed via spreadsheets and IT applications, then manually, consolidated to complete tasks and make management decisions.

The problem with these methods is their inefficiency and the large time investment they require from employees in order to keep records up to date. Read how three healthcare organizations automate their regulatory document management processes to increase operational efficiency, reduce cost and improve quality.

Reducing the complexity and cost of clinical trial regulatory document management

A major cancer center recognized the opportunity to dramatically reduce management complexity and cost by transforming their clinical trial regulatory document process. This comprehensive cancer center offers its patients opportunities to participate in more than 500 clinical trials at a multitude of locations across the country. They simplified their clinical trial regulatory documents collection, management and access by collaborating with VACAVA, Inc. to design and implement an affordable custom application specific to their needs.

Paper documentation has been replaced with easy-to-create online forms, a single source of online information has eliminated confusion caused by multiple paper versions, and all signatures are obtained via electronic signature. The cloud implementation enables remote review of regulatory documents to ease the review process performed by monitors and auditors. This new application has enabled the institution to significantly increase efficiency and quality, while reducing the cost of its research regulatory document management process.

Preparing for exponential growth in regenerative medicine

A manufacture and distributor of stem cell culture media recognized the need to rapidly scale production as their pharmaceutical clients were completing clinic trials and preparing for commercial use.

In the highly regulated pharmaceutical industry, auditability and trackability of every critical material is imperative. Patient and product safety is a matter of utmost importance. Therefore manufactures, must implement audit and tracking processes that document critical materials from supplier, through manufacturing, to the end user. The custom application developed by VACAVA, Inc. supports the collection, retention, management and access of this supplier's, manufacturing and end user data supporting Good Manufacturing Process (GMP), ISO, and CFR regulations.

By implementing a cloud-based document solution from VACAVA, this manufacture now has an infrastructure that will enable them to rapidly scale efficiently and productively, without adding exponential staff or technology expense.

Improving the efficiency and cost of Lab Certification and Accreditation Management

Recently, a major Minnesota healthcare provider realized the value of changing their process for lab certification and accreditation management. With 190 labs running over 2 million tests per year, the provider's process of manually tracking certificate completion, maintenance and expiration dates in a spreadsheet was challenging.

Collaborating with VACAVA, they designed and implemented a software application which simplifies data collection, management and access. The cloud-based implementation enables remote data entry in a real-time sharing environment and introduces features like certification renewal notifications, compliance reports, profile management, certificate archiving and automated certification/accreditation form population. With the help of this new solution, the organization has increased its efficiency and reduced its costs.

These are three different Healthcare teams who embarked on similar strategies to improve their efficiency and costs through smarter regulatory document management.

Learn how VACAVA can help your organization. Contact me today.

VACAVA. Inc.

VACAVA's mission is to deliver high-quality, affordable custom applications that allow companies to reengineer their existing processes and operate more efficiently and effectively. VACAVA's solutions are tailored exactly to the needs of the organization, allowing us to work with companies of all sizes, from fledgling ventures to Fortune 500 companies.

Is it time to change your processes to operate more effectively?

5 signs it’s time to change your business process

In the medical industry, organizations are constantly seeking ways to increase efficiency, improve quality and reduce costs. However, it can be difficult to know where to start. I have had the good fortune to work with many organizations and found that rethinking your business management processes & procedures can make a surprising difference in the efficiency of your operations. From my experience, it's time to make a change when:

1. You depend upon paper forms that are copied and placed in numerous locations, approved by multiple individuals, and audited manually.
The cost of manual processes to organizations can be significant in both inefficiencies and the added cost of resources to organize them. Your team may never complain about the time they spend locating and updating paper forms, replacing outdated information, manually replicating and filing the documents, and tracking lost documents. Why don't they complain? Because that is what you hired them for and unless they know of a better alternative, they will do the best job they can with the resources they have.  

2. You supplement IT systems with desk procedures and spreadsheets.
Your core business applications may have supported your operations when they were first installed. However, your business requirements don't stand still and frequently the applications can't keep up. Rather than incur additional IT expenses, you have adapted to change by adding desk procedures and spreadsheets into your process. Spreadsheets can be flexible and sophisticated, but they are not always the right solution.  Are you managing your critical business processes from manual spreadsheets?  How do you explain and remedy "multiple versions of the truth"?

3. You invest considerable effort into manually consolidating data to complete tasks or make management decisions. 
Sometimes it takes a lot of data to make the right decisions. But if that data is scattered across multiple systems, databases, and spreadsheets it can take significant time to pull the data together.  Does your decision-making and management process rely on complex data consolidation by experienced staff? Is this the most effective use of their time; are you prepared for the day they take a different job?

4. You use personal technology to be more effective at your job. 
With technology so affordable, your staff may bring their own devices to work; use public cloud storage or other technology that is out of your control. This is a sign your technology is seriously out of date. Where is your critical business data being accessed from and stored? Is your data secure and compliant with regulatory requirements?

5. You work in a highly regulated industry requiring detailed auditing and tracking capabilities.
The sheer amount of paperwork and detailed tracking required for regulatory compliance can be daunting. Managing this on paper and spreadsheets is an exposure waiting to happen. Does regulatory compliance keep you up at night?

If these signs sound familiar, it's probably time you start looking for a change. Automated and optimized business processes can deliver cost and quality improvements while easing minds, facilitating audits, and making better use of your valuable staff.

Learn how VACAVA can help you.  Contact me today.

About VACAVA Inc.
VACAVA's mission is to deliver high-quality, affordable custom applications that allow companies to reengineer their existing processes and operate more efficiently and effectively. VACAVA's solutions are tailored exactly to the needs of the organization, allowing it to work with companies of all sizes, from fledgling ventures to Fortune 500 companies.

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‘Oh Crap,’ Was That Today? Keeping on top of regulatory document management

by Terry Bird

Anyone who works with regulatory documentation knows it can be difficult to stay on top of all the associated documents, requirements and deadlines. Let one aspect of the process slip your mind and you’ll feel like you are watching the ark sail away as the water rises around you. Failing to maintain proper regulatory documentation can end up costing your organization both money and your good reputation, making it more difficult to acquire new business and funding.

The procedures for managing regulatory documents can pose organizational problems. Most organizations track and complete these forms on paper. The forms need to be approved by multiple people, copied and stored in numerous places, which is made even more complicated when there are multiple locations in a network that need to maintain the same information. This leads to dozens of chances to miss a deadline, misplace a form or end up with incorrect information being submitted.

An opportunity to improve efficiency and reduce cost

Recently, a major Minnesota healthcare provider realized the value of changing their process for lab certification and accreditation management. With 190 labs running over 2 million tests per year, the provider’s process of manually tracking certificate completion, maintenance and expiration dates in a spreadsheet was challenging.

Collaborating with VACAVA Inc, a custom solution provider, they designed and implemented a software application which simplifies data collection, management and access. The cloud-based implementation enables remote data entry in a real-time sharing environment and introduces features like certification renewal notifications, compliance reports, profile management, certificate archiving and automated certification/accreditation form population. With the help of this new solution, the organization has increased its efficiency and reduced its costs.

Reducing the complexity and cost of clinical trial regulatory document management

A major cancer center also recognized the opportunity to dramatically reduce management complexity and cost by transforming their clinical trial regulatory document process.  This comprehensive cancer center offers its patients opportunities to participate in more than 500 clinical trials at a multitude of locations across the country. They simplified their clinical trial regulatory documents collection, management and access by collaborating with VACAVA, Inc. to design and implement an affordable custom application specific to their needs.

Paper documentation has been replaced with easy-to-create online forms, a single source of online information has eliminated confusion caused by multiple paper versions, and all signatures are obtained via electronic signature. The cloud implementation enables remote review of regulatory documents to ease the review process performed by monitors and auditors. This new application has enabled the institution to significantly increase efficiency and quality, while reducing the cost of its regulatory document management process.

VACAVA. Inc.

VACAVA’s mission is to deliver high-quality, affordable custom applications that allow companies to reengineer their existing processes and operate more efficiently and effectively. VACAVA’s solutions are tailored exactly to the needs of the organization, allowing us to work with companies of all sizes, from fledgling ventures to Fortune 500 companies.

Learn how VACAVA can help your organization. Contact me today.

Making your lab worry free

LabRight Certification

Even the best-laid plans can falter due to logistical issues, and a lab is no exception. The sheer amount of paperwork involved with running one can be daunting, especially when it comes to the certifications that are crucial to allowing the lab to continue working penalty-free. At the same time, allocating working hours to keeping track of all of these details siphons valuable resources from other tasks.

That’s where VACAVA’s LabRight Certification comes in.

LabRight manages the details of your certifications so you don’t have to. You can store lab profiles, stay aware of renewal dates and create easy-to-read reports for efficient auditing, all in one handy resource. Plus, when it comes time to renew your certifications and accreditations, the software automatically fills out the forms for you, eliminating the efficiency and quality concerns associated with manual form completion.

Your lab’s resources shouldn’t be tied up in continually monitoring certification deadlines or paying costly penalties for missing them. The less energy you’re compelled to devote to logistics, the more you will be able to retain for the tasks that truly matter.

LabRight can assist in a variety of areas, including but not limited to:

  • CLIA (Clinical Laboratory Improvement Amendments)
  • CAP (College of American Pathologists)
  • AABB (American Association of Blood Banks)
  • AOA (American Osteopathic Association)
  • ASHI (American Society for Histocompatibility and Immunogenetics)
  • COLA (Commission on Office Laboratory Accreditation)
  • TJC (The Joint Commission)

Want to learn more about VACAVA’s LabRight Certification, and the benefits it can offer you? Visit www.vacava.com/labright.