Quality System CFR 21 Part 11 Compliant

How to Make Your Quality System CFR 21 Part 11 Compliant

In this article we will discuss major CFR 21 part 11 requirements. We will present how an Office/SharePoint-based quality management system complies with relevant regulations for the life science industry.

People who use systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and the confidentiality of electronic records.

 

Quality System CFR 21

This means an electronic system needs to clearly identify users and assign the right permissions to create, validate or read documents inside and outside the organization. Electronic signature makes sure authorized users can prepare and edit documents. Once a document is published, the system declares it as a record for the specified retention period. Information right management policies restrict users from copying or printing documents, even if documents are saved outside the system. Workflows enforce document approval and signoff. An audit trail has to be kept with a document throughout the document and record life cycle. Most of these technologies are part of native Microsoft Windows, Office and SharePoint.

Signed electronic records  clearly indicate the following information: the printed name of the signer, the date and time when the signature was executed, the meaning or responsibility associated with the signature. With Microsoft Office and SharePoint, digital signatures are stored as part of the document. Electronic signatures are stored as part of the audit trail and metadata associated with the document when signed as part of a workflow. The linkage between signature and document is maintained by the server.

Each electronic signature shall be unique to one individual. With Microsoft Office and SharePoint, Active Directory enforces a unique user ID and password for each user. Procedures and policies should be in place to ensure user credentials are periodically checked. Failed login attempts will be logged by Windows Server and related user accounts can be locked out.

Three topics need to be addressed when validating the system: installation qualification, operation qualification and  performance qualification. In the end, the system should perform to the end user’ needs.

The implementation of an electronic signature system must be simple for end users but rigorous enough to meet the organization’s need for record keeping within the organization.

BPA Quality is running on the latest Microsoft SharePoint and Office 365 technologies. BPA contains all necessary technologies to build a CFR 21 Part 11 compliant system. BPA Quality is cost effective and adapted to the needs of very small to large businesses.

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Proces map

Driving Efficient Risk Management

Risk management is a fundamental part of your Quality Management System. In the latest ISO 9001:2015 quality standard, risk management has become a central preoccupation.

Risk management is about developing a preventive attitude to avoid the occurrence of unfortunate events. In managing risks, companies can save resources, improve productivity and increase collaborators’ safety and health.

Not just used in banking or insurance organizations, an efficient risk management can have a direct impact on profits, revenue and business continuity.

A typical risk management process contains 4 main steps:

  • Risk identification
  • Risk assessment
  • Risk treatment
  • Risk monitoring

It’s good to start by defining company processes prior to identifying risks. A process map illustrates value added and resource processes in order to deliver valuable products/services to satisfy customers.

 

Knowing issues, indicators and risks for each process gives clear insights on how to make improvements.

There are 2 ways to identify risks, on the strategic or operational level. SWOT or stakeholder expectation analysis are great tools to identify strategic risks. In daily operations, issues, complaints, audits, correctives actions, indicators, etc. are typical events used to  detect risks. A recurring issue is a typical source for declaring a new risk.

 

 

Different methodologies exist to assess risks. A simple one is to assess probability/occurrence and impact/gravity of risks. The risk severity is the multiplication of probability by impact factors. The impact is sometimes expressed as a monetary value. In FMEA’s methodology (Failure Mode and Effects Analysis), the risk severity is the multiplication of three factors: impact, probability and detection. The risk severity is often displayed in a risk heat map for a specific period. A scorecard is an ideal tool to monitor risk assessment values over  time with their trends.

methodologies assess risks

 

High severity risks display in the red zone of the heat map. These risks need to be treated. Corrective actions are assigned to the process owners, to reduce the risk probability or impact. Periodical controls are set to monitor risks.

Risk compliance documents will be needed to describe your risk methodologies and procedures with their related instructions. These documents are usually part of your quality document management system.

Excel spreadsheets are not ideal to manage risks with their related actions and controls. Excel is a personal tool that is not adapted for collaborative work.

An integrated digital quality management software like BPA Quality will help quality managers to have a participative quality and risk management system.

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BPA Quality for Office 365 – A Game Changer For Quality Managers

It’s almost released. BPA Quality for Office 365 represents a game changer for Quality Managers. It’s a plug and play QMS software fully integrated with your Office 365 system.

The time of spreadsheets, databases and expensive QMS solutions is over. Quality Managers, we will change your life.

The 4th generation of BPA Quality integrates with the best Office 365 collaborative technologies. Embedded technologies in BPA Quality allow instant discussions, team collaboration, workflow automation, mobility, advanced reporting and many more.

QMS Office

The time for digital quality has arrived. The latest Microsoft technologies will help making your QMS participative, distributing tasks to the concerned persons and taking faster decisions.
Decentralizing the QMS, Quality Managers will have more time to spend on interesting activities to renew certificates and improve processes.

BPA’s digital quality software will prevent administration work to manage heavy paper systems and drastically save costs.

Typical QMS software are complex, expensive and not flexible. The time has come for a user-friendly and cost effective solution adapted for any industry sector and company size.

BPA Quality for Office 365 is soon available to be installed from the Microsoft store.

>> Let us know if you’re interested to know more about BPA Quality for Office 365.

Quality Managers – We Will Change Your Life

Quality Managers – We Will Change Your Life

How looks a typical day in a Quality Manager’s life?

Beside operational quality matters, Quality Managers and their team spend a lot of time to administrate heavy paper systems.

Because of the lack of adequate systems, Quality Managers have to deal with a lot of Excel files, retyping data again and again to have consolidated information on processes. Excel is an individual solution that is not adapted to solve quality matters.

Database systems are common to store quality data, like non-conformances, CAPA and others. Even if databases have several advantages compared to Excel files, they miss user-friendliness and collaborative features. Usually, these databases have been developed internally and become obsolete once developers leave the company.

Plenty of digital Quality Management solutions exist in the market. They will bring several advantages like integrating many modules in one single solution. However most of these solutions are intended to larger organizations, they are expensive with a long time to deployment and often built on non-flexible proprietary technologies. Return on investment with such solutions is unclear.
unclear

Quality Managers, we know your pains and will change your life.

>> Discover our SharePoint QMS solution

Office 365 users, stay tuned it’s coming very soon for you too…

Quality Managers – The Time Has Come to be Recognized for Your Work

Quality Management used to be an inessential responsibility plotted in the organization chart of many companies I was helping to get certified. It’s like there was no clear position in the organization chart for Quality Management. Even today, the Quality Management function is not always fully recognized.

Quality Manager

Like a music director leading his musicians, a Quality Manager needs to have very close relations with all service managers in the organization. The concert will only play in perfect harmony if director and musicians do their part of the job. There needs to be quality orchestration.

Unfortunately, in many organizations, Quality Managers have to play the music alone, with limited support from process managers and poor sponsorship from General Management. Chasing and motivating collaborators that are not fully engaged in the QMS becomes a daily task for Quality Managers.

As a result, Quality Management has turned out to be centralized, less efficient and Quality Managers lack recognition for their work.

The time has come for Quality Managers to be recognized for their work.

>> Discover our SharePoint QMS solution

Office 365 users, stay tuned it’s coming soon for you too…

quality consultant proposal

Unique Value Proposal for Quality, Compliance & Risk Consultants

If you have extensive consulting experience and network contacts within the Quality Management sector, and if you have access to decision makers and influencers, then this proposal is for you.

Performing sales organizations don’t work with spreadsheets anymore, but with powerful CRM systems. In the quality management domain, companies that run a digital QMS system will drastically increase their competitiveness and efficiency.

Today, customers expect advice from their consultants in order to select the most adapted digital solutions for their needs.
Unique Value Proposal for Quality, Compliance & Risk Consultants

 

Consultants, BPA is aware of this and has developed the most flexible digital QMS system to support your consulting methods, tools, and strategies. You and your clients don’t have to adapt to a rigid system anymore— BPA will adapt to you. As a consultant, you have full control in configuring the QMS for your clients, sharing content and methodologies, proposing added-value services, and getting additional recurring revenues. Our QMS system is accessible anytime and anywhere for you and your clients, even very small companies with less than 20 users.

Here is our promise to your customers. We want to make Quality, Compliance, Risk Managers recognized in their organizations by delivering a collaborative and participative QMS tool, where collaborators will be engaged. We want to reduce Quality Managers’ administration work with a simple and integrated Microsoft-based system. Finally, we want to facilitate the certification process and help your customers develop their businesses.

Consultants, here is our proposal for you. Through your network, you have customers that seek to implement digital Quality Management Systems. We want to make it worth your time if you bring us a lead, a qualified lead or a deal, and propose you high commissions from 5 to 30% in case the deal is closed.

We believe that this is a great proposal that can really create a win situation for all involved.

>> Make Your Clients Happy in Becoming a BPA Partner

quality manager

Breaking News – A New Era Has Come for Quality Managers…

Many factors explain Quality Managers’ life has become harder today.
Quality Management

We live in a more and more regulated world, which means Quality Managers are not only responsible for Quality Management anymore but also health, security & environment management.

More and more regulations and quality standards have been created the last decades and Quality Managers are now frequently audited on many standards to maintain certifications.

Not later than 2018, companies need to transition to the latest ISO 9001:2015 release and this will require additional efforts for Quality Managers to manage risks, opportunities and more.

As a result, quality management systems become more and more complex and heavy to manage. Quality managers spend a lot of time to manually administrate their QMS because no adequate digital solution exist.

But, a new era has come for Quality Managers. Discover our SharePoint QMS Now

Office 365 users, stay tuned, it’s soon available too…

2018 Deadline: How a Digital QMS Can Help You to Renew Your ISO Certificate

2018 is the deadline when ISO 9001 certified organizations will need to move to the new ISO 9001:2015 standard.

Meeting the new ISO 9001:2015 requirements will need additional extensive paperwork and Excel spreadsheets. Do you really want to make your actual QMS even more complex to manage?

Why is now the right moment for your organization to move to a digital QMS?

An ISO 9001:2015 compliant digital QMS will ease the transition to the new standard because tools have been specifically developed with quality professionals to match new requirements, such as risk management, opportunity management or SWOT analysis.

digital QMS

An integrated digital QMS will drastically save time for Quality.  Rather than spending time to administrate heavy paper-based systems and tons of Excel spreadsheets, Quality Managers can focus on value added processes and transition to the new standard. With an integrated QMS, you get the full picture for any quality process and drive continuous improvement.

ISO 9001:2015 brings a new opportunity for your organization to rethink your QMS and make it more efficient.

In moving from a paper-based and standalone system to a digital collaborative QMS you will better interact with collaborators and executives and make your QMS participative. Engaging with collaborators will bring your QMS to the next level.

The 2018 deadline is approaching. Use this great opportunity for your organization to simplify and improve your existing quality management system by moving to a digital integrated and collaborative QMS.

BPA has developed a cost-effective and integrated collaborative QMS based on the latest Microsoft SharePoint and Office 365 technologies.

Save time and cost while making your QMS more efficient and compliant with the new ISO 9001 standard.

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SharePoint QMS

Why SharePoint Is the Right Foundation for Your QMS

SharePoint 2016 is the sixth generation of the worldwide number 1 collaborative technology developed by Microsoft. With millions of users and more than a billion of revenues, the Microsoft SharePoint technology has reached maturity. The SharePoint ecosystem includes thousands of developers, partners and third party tools.
 
SharePoint has become a central piece in Microsoft’s Office 365 cloud offering. Many new technologies have been lately developed by Microsoft that will accelerate digital transformation, like Microsoft PowerApps and Flow allowing users to access data anytime and anywhere. A new era of collaboration has started and the technology is ready for it.
 

Sharepoint

 
Microsoft SharePoint is a feature-rich platform, including native and powerful document management, workflow automation, social and chat (Yammer), telephony (Skype), email, mobility, search any many more features. Thanks to the native integration with Microsoft Office tools, SharePoint gives the best user experience.
 
The SharePoint technology allows workspaces on demand creation, and provisioning a new site takes less than a minute. A company can create independent workspaces per business unit, plant or region. The technology is fully scalable and adapted for small to large organizations.
 
SharePoint’s entry cost is very low. It can be deployed on premises or used in the Office 365 cloud. SharePoint Foundation doesn’t require any additional software license if you have a Windows server running.
 
SharePoint brings a powerful foundation for your QMS initiatives. However, Microsoft SharePoint is not a QMS software.
 
BPA has developed an all-in-one and ready-for-use QMS solution built on Microsoft SharePoint and Office 365 technologies. 30+ components have been developed to drastically improve user experience, user interface and user productivity when using SharePoint.
 
ready-for-use QMS solution built on Microsoft SharePoint and Office 365 technologies

 
Using BPA on the top of SharePoint will avoid any costly and time-consuming SharePoint development, and our components solve challenges met by developers again and again.
 
BPA aligns with IT strategies to reduce the number of technologies deployed and cost. Compared to risky proprietary technologies, BPA is built on a no-risk and standard technology. This considerably lowers the risk of software obsolescence.
 
Maximize your return of investment with our cost-effective QMS solution.
 
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Introducing BPA Quality 2017

Introducing BPA Quality 2017

BPA Quality 2017 is the next generation of software for quality, risk, compliance management and internal control built on the #1 Microsoft SharePoint technology.
Don’t spend time retyping data in heterogeneous Excel files and systems. With BPA you can replace Excel/Office files & databases with one single integrated solution, drastically saving administration cost.

BPA is a unique solution supporting all needed collaborative technologies for improving your processes, like task, email, calendar, picture and document management. As a result, you get the full picture for any quality record.

For example, you can add an Outlook email as a non-conformance including attachments. Pictures can be added to describe the problem. Emails and documents will be managed and traced in the system. Tasks and meetings will be tracked in the tool and synchronized with Outlook.
Introducing BPA Quality 2017

Let your BPA QMS distribute tasks automatically and plan the work for each concerned end user.
Automatic tasks with email notifications are sent to the concerned persons to qualify, investigate, define an action plan and verify effectiveness of related actions. This will drastically save time and cost.

BPA Quality 2017 includes prebuilt Nintex workflows for non-conformance and compliance document approval processes. In 2014, Forrester Research conducted a study “The Total Economic Impact™ of the Nintex Workflow Platform” and interviewed many organizations. Benefits of automating processes with SharePoint were clearly demonstrated. 3-year results are the following:

  • ROI : 176%
  • Payback: 10,5 month
  • Productivity increase per user: 8-15%

BPA Quality 2017 will save you time and money while improving efficiency for every compliance processes.

>> Access Your BPA Quality 2017 Trial Now