Slingshot Blog

Investing in the future of your business during periods of economic uncertainty is what separates your business from the competition. Industry leaders confirm that now is a good time to make strategic investments in your company’s operational systems. ERP software should be on top of your to-do list, given the positive impact that improvements in procurement and supply chain management can have on your bottom line.

Slingshot’s Momentum promotion is all about enabling you to invest in your business at a time when the greatest competitive advantage can be gained. Our Momentum campaign enables you to defer software licensing costs until two consecutive quarters of GDP growth are published.

Your ROI will skyrocket when the recovery kicks in, and your operational efficiency goals will be met and exceeded at the same time.

By all means, contact us to discuss the Momentum campaign, and how it might unlock much needed investment in your business systems. Slingshot provides a genuine low cost alternative to your ERP software challenges.

Labels: economic uncertainty, ERP Software, promotion

For some time now, statistics have shown a steady increase in the Food and Drug Administration's (FDAs) monitoring of pharmaceutical companies' compliance with 21 CFR Part 11 and other regulations.

This article in the New York Times makes reference to this, and the Federal Government's increasing focus (through the Government Accountability Office) on the safety of all pharmaceutical products (both equipment and medicines) on the market.

The article highlights a situation where the Federal Government is now insisting on retro-active compliance of medical devices that pre-date the enactment of medical device law in 1976. This kind of scrutiny from all regulatory bodies can be expected to increase over time.

The issue of Combination Devices is a particularly important one right now as the charter of a number of separate FDA departments have been combined to make sure that compliance regulations are properly maintained and monitored.

Labels: 21 CFR Part 11, combination products, pharmaceutical

Webinar Title: Using Next Generation Software Technology to Satisfy Compliance and Best Practice Requirements

REGISTER NOW

Webinar Overview

Slingshot Software is pleased to announce that it will be hosting a free Webinar that is all about using technology to turn your compliance against 21 CFR Part 11 - and other regulations - into an undeniable competitive advantage.

Businesses across the pharmaceutical, biotechnology, medical device manufacture and life sciences industries are finding that FDA scrutiny is increasing against regulations like 21 CFR Part 11. What's more, compliance to 21 CFR Part 11 and an increasing number of regulations just like it is becoming more complex.

Slingshot recently helped one of their major clients in the pharmaceutical industry to automate many of their processes that were previously paper based, or prone to human error. At a time when scrutiny of company processes is increasing and when efficiency is a major competitive advantage, good business systems become critical.

In the context of regulatory compliance - against 21 CFR Part 11 and others - the Webinar will address:

• The need for pharmaceutical businesses to track processes and maintain accountability.
• How to make inventory tracking more effective and visible across all process participants.
• How to achieve a state of audit readiness now and maintain it into the future as requirements evolve.

When, Where and How?
Title: Using Next Generation Software Technology to Satisfy Compliance and Best Practice Requirements - Turning 21 CFR Part 11 Compliance Into Competitive Advantage

Date: Tuesday, April 14, 2009

Time: 2:00 PM - 2:45 PM EDT

After registering you will receive a confirmation email containing information about joining the Webinar.

REGISTER NOW

Labels: 21 CFR Part 11, FDA, pharmaceutical, slingshot software, Webinar

What is Title 21 CFR Part 11?
The Code of Federal Regulations Title 21 CFR Part 11 (referred to as 21 CFR Part 11) regulates the use of electronic systems in clinical trials. Any pharmaceutical company seeking to submit their clinical trial results to the US Food and Drug Administration (FDA) must first comply with 21 CFR Part 11 as part of their trial and pharmaceutical commercialization process.

A separate entry in this blog (21 CFR Part 11: What Do I Need to Know?) discusses 21 CFR Part 11 in a more general sense, explaining its objectives at a summary level.

This entry discusses what you will need to have in place to make sure the electronic signatures applied by your systems are legally binding.

Electronic Signatures and 21 CFR Part 11
Electronic signatures, as an enabler of automated work flows, can introduce significant efficiencies to the day-to-day operations of your business. To be effective however, electronic signatures need to be applied in manner that conforms to the FDA 21 CFR Part 11 regulations. A full description of the rule on electronic signatures can be found here. While it’s a serious piece of bed time reading, it does layout the steps you need to take to ensure that the electronic signatures applied within your systems are compliant.

To summarize what it says, the following three points are important to consider:

• System Controls: The functionality of your system needs to be supported by a series of controls that are compliant with 21 CFR Part 11 which controls will also ultimately make your procedures easier to implement. This refers to the work typically performed by a System/Security Administrator who manages user access to the system, accrual of audit trail history, policies for individual user accountability and proof that adequate training has been delivered. Role based security plays a big role here, as its effective implementation limits a user’s access and delegated authorities within the system.

• Signature Controls: Each time an electronic signature is applied, re-entry of the approver’s Username and Password may be required. Automated prompts for continual re-entry of login details can become counterproductive and cumbersome. This makes role based security and appropriately delegated authority the safest and most productive approach.

• Password Controls: System access must be gained by entry of two unique elements, most commonly a user name and password. These details must also be protected by normal controls such as expiration, forced complexity and deactivation after excessive unsuccessful login attempts. Encryption and other safeguards should also be considered. Single login functionality, which relies on Windows authentication, is an efficient way to pass a user’s identity, role and authority through to your requisition and inventory control systems where electronic signatures are applied.

Procedures and Systems Must Work Together to Achieve 21 CFR Part 11 Compliance
It is important to keep in mind that while a piece of software can enable you to be compliant with 21 CFR Part 11 and its regulation of electronic signatures, it is ultimately your procedures that ensure your compliance. Once both are in place though, any FDA audit that assesses your compliance with 21 CFR Part 11, will become far less onerous.

Electronic signatures are the heart beat of your on-line work flow based system, and the processing efficiencies that are possible by using it properly can lead you to far greater organizational efficiency, growth and profit.

Labels: 21 CFR Part 11, Electronic Signatures, pharmaceutical

The Changing Business Processes Situation
Some manufacturers are now commercializing their own products and are starting to function as wholesale distributors as well. The economic compulsion behind this strategy shift is bearing fruit, however it is instigating changes to business process more quickly and more profoundly than has previously been the case.

Rather than pushing legacy Enterprise Resource Planning (ERP) software systems well beyond the intent of their original design (in many cases based around best practices of the 90’s) manufacturers are discovering a new breed of ERP software systems that can support their changing business processes, and also enable this shift in strategy far more than was previously the case.

The Drivers Behind Changing Business Processes
One of the following four things will drive your ERP software and vendor selection project:

• Regulations/Compliance
• Operational Efficiencies
• Growth Plans
• Changing Strategy

Whatever the driver, the current economic climate dictates that your project will be implemented in an environment where regulation and compliance laws are getting tighter, as are the requirements (both legal and commercial) to be green, sustainable and carbon neutral in all operations. Can you have your cake and eat it too?

The Solution
By having a handle on their business processes, manufacturers can apply a new style of software that can be changed without programming. There are a number of emerging ERP software products that use business rules engines, rather than hard coded functionality, to mold business process frameworks to exacting needs. Such an ERP software system will be:

• Delivered as a series of modules, each functioning independently or in seamless integration as required
  
• Extendable, to suit changing business processes without programming
• Distributed via the internet such that trading partners can be included in on-line transactions
• Able to deliver all decision support information (key performance indicators via dashboards and reporting etc.) accurately and quickly (in real time) to role based users
• Work flow and alert enabled so that exception conditions can be quickly corrected after notifications are delivered electronically
• Available on desktops, mobile devices and anywhere your workforce may be

The new breed of ERP software is driven by changing business processes, business rules and business rules engines that are inherently flexible and can be easily changed as needed.

The To-Do List
This is a serious topic. And serious topics come attended by serious to-do lists. The dot points below are somewhat of a hybrid “Project Management Vs. ERP Software Implementation” best practices punch list, however, they’re all applicable as we consider changing business processes and how to deal with them:

• Step 1: Lobby for, obtain and document senior level sponsorship for your innovation/project.
• Step 2: Design the organization that will be required to support both the changing business processes and changed business processes (a classic change management exercise).
• Step 3: Align business and IT challenges. It sounds trite, however changing business processes demand clarity of business objectives before any ERP software can be considered much less designed.
• Step 4: Define and document your business processes. Clearly state your innovations and differentiators in the market place.
• Step 5: Document the architecture, functionality, distribution and infrastructure required of your new system in a long term application strategy.

Here are a couple of tough ones, just for luck:

• Step 6: Decide to include your trading partners into your day-to-day transacting. As a first step, this can cause some angst (security for one consideration), however, the operational efficiencies in doing so provide ample justification.
• Step 7: Allow for innovation in your budgeting. Each step above requires the investment of time by all affected stakeholders. The attendant shift in approach to ERP software (especially in a system that supports your businesses’ changing business requirements) will require investment; however it is likely to pay off faster than you think if done properly.

Then, And Only Then:
…should you set about determining a development partner who can deliver a solution that aligns with your vision for changing business processes.

Making these changes will change your fortunes for the better.

Good luck

Simon

Labels: business requirements, changing business processes, ERP Software

So it's come time to take your systems forward and implement electronic signature management. To achieve success, you'll need to know all about the Code of Federal Regulations Title 21 CFR Part 11.

Code of Federal Regulations (CFR): Title 21 CFR Part 11 - What Is It?
The Code of Federal Regulations Title 21 CFR Part 11 sets forth the business system access standards necessary to replace paper based signatures with electronic ones. For reasons of efficiency, electronic signatures are becoming standard practice. While electronic signatures are efficient, they are also exposed to additional security considerations.

What Do I Need To Know When Selecting a New System?
The Code of Federal Regulations (CFR) - Title 21 CFR Part 11 regulation requires that companies implementing electronic signatures in favor of hand written ones ensure the systems they use comply with the following provisions:

• Passwords shall age, and require periodic update by their (the more often the better)
• User access shall comprise two components: user identification and a password
  
• On failed entry, no indication shall be provided as to which of the user ID or password information failed validation
• After 3 unsuccessful log in attempts, access for that user shall temporarily be suspended
• Password strength shall be measured and recommendations made to improve it
• Paper based acknowledgment of these conditions shall be held on file for each user of the system

And, while it sounds a little futuristic, biometric system access including - but not limited to - fingerprint recognition and voice/retina scanning are also accounted for in the Code of Federal Regulations.

A series of standard operating procedures (SOPs) will also need to be in place to ensure that all the "compliant" provisions of the business system are supported by business operations.

Code of Federal Regulations: Title 21 CFR Part 11 Audits
Particularly in the life science/biotech industry, the U.S. Food and Drug Administration (FDA) is becoming increasingly vigilant about compliance with this particular Code of Federal Regulations. The number of random audits as well as the fines for non-compliance within specified time frames are both increasing.

Slingshot systems are compliant with all Code of Federal Regulations requirements, and we strongly recommend that you review the level of compliance of any business systems you are looking to implement now and in the future.

Labels: 21 CFR Part 11, compliant software, pharmaceutical

Slingshot recently published a White Paper titled the The Five Simple Secrets to a Successful Software Initiative.

You can download the document here.

The purpose of the document is to answer the question "How do you eat an elephant?" The answer of course is "piece by piece". It's been developed to help people charged with, or involved with, the selection and implementation of a significant business system within any organization of any size - a daunting task in any one's language.

The Five Simple Secrets are a distillation of the Slingshot management team's accrued experience, gained over many decades through consultations with hundreds of companies just like yours. Be assured, the secrets are logical and pragmatic, and while some may be challenging to achieve in your environment, the ability to articulate them to your management team will ensure you get their full and immediate support.

The upshot: If you're able to implement the Five Simple Secrets, you will improve your chances of achieving "golden-team-member" status significantly. Isn't that what's it's all about?

Good luck and well wishes from the Slingshot Team!

Labels: ERP project, secrets of success, software implementation