News reports of data breaches, hacks, and other system intrusions continue on a regular basis. It is critical that software designers build secure databases that are highly resistant to hackers and meet information security standards. Both CFR 21 part 11 and ISO/IEC 27001 establish requirements for secure information systems and electronic records. CFR 21 part 11 is part of the Code of Federal Regulations that establishes the US Food and Drug Administration (FDA) electronic records and electronic signatures requirements. ISO/IEC 27001 specifies the requirements for establishing, implementing, maintaining and continually improving an information security management system within your organization. SBS essentially offers two levels of databases. While security is critical, cost and connectivity important factors. SBS standalone databases require username … Continue reading Information Security, Electronic Records and Electronic Signatures in SBS Products
Sunday Business Systems offers two very similar products for employee training management for different levels of compliance. The SBS Training Database and the SBS T-Med Database both offer solutions for defining roles and responsibilities, training requirements, and recording training history, etc. (refer to the Feature Comparison Table). The Training Database was designed for basic compliance where there are slightly less rigorous requirements. The database is an excellent source of objective evidence that training programs have been defined and are being executed in an efficient manner. It is also an invaluable tool to ensure measures of training effectiveness are maintained. The SBS T-Med Database was designed for rigorous compliance to FDA standards (21 CFR Part 820 and ISO 13485) with CFR21 … Continue reading Training and T-Med Databases Compared
Is there an ISO Standard for everything?? ISO 10019:2005 provides guidance for the selection of quality management system consultants and the use of their services. It is intended to assist organizations when selecting a quality management system consultant. It gives guidance on the process for evaluating the competence of a quality management system consultant and provides confidence that the organization’s needs and expectations for the consultant’s services will be met. While the concepts in the standard are sound, interpreting and adapting the standard to meet your individual business needs is critical. Key selection objectives: Ensure the consultant has a proven track record Ensure the plan is focused with achievable objectives Ensure the project time frame is in line with senior … Continue reading Selecting QMS Consultants
This report details how Sunday Business Systems software can be used effectively and efficiently to meet the rigorous requirements of ISO 9001:2015. Key sections of the ISO 9001 specification are broken out and overlaid or matched to our products key features. From this report, you can see how well our eQMS products serve ISO 9001 compliance. Download the full report by clicking here.
Sunday Business Systems offers SQL versions of our standard products. From the user perspective, the SQL version is identical to our demo version except the underlying data is stored in Microsoft SQL tables. The user interface, or Microsoft Access front end, connects to the SQL back end through our proprietary DSN-less Technology. Our DSN-less Technology allows easy connection without having to create and maintain individual ODBC links from each user’s computer. SQL versions provide a higher level of data and user security while providing the same user experience and performance. SQL administrators may add additional levels of user security and automated back-up strategies to protect sensitive company data. To install the SQL version of our product, your company must … Continue reading Tech Note: SQL Based Software Solutions
If you have the full version of Microsoft Access, you may use the spell checker to correct any spelling errors on data that is entered. The spell checker is normally located on the Home menu ribbon. Simply place the cursor in the field you want to spell check and click on the spell check icon. For a full set of instructions click here. If the spell checker icon is hiding, you can expose it by adding it to your Quick Access Tool Bar. Click on the Quick Access Tool Bar control box then Click on More Commands Set Choose commands from: Popular Commands Click on Spelling Click Add>> (to add icon to the toolbar) Click OK Now you can begin … Continue reading Tech Note: Spell Checking Data
The SBS Quality Database has been upgraded to better meet the requirements of ISO 9001:2015. In addition to the existing features like Corrective Actions, Non-conformance Management, Audit management, etc. we have added a module for Risk Management. Changes to Address Risk and Opportunities The 2015 version of the standard requires the organization promote the use of the risk-based thinking and to determine the risks and opportunities when planning the Quality Management System (QMS). To help ensure good customer satisfaction, the organization must address the risks and opportunities that can affect product or service conformity. The organization must then take actions to address the risks and opportunities and ensure these actions are proportionate to the potential impact. Finally, the organization must … Continue reading The SBS Quality Database for ISO 9001:2015
Sunday Business Systems offers two very similar products for different levels of compliance. The SBS Quality Database and the SBS Q-Med Database both offer solutions for Corrective and Preventive Actions (CAPA), Non-conformance management, audit management, etc. (refer to the Feature Comparison Table. The Quality Database was designed for basic compliance where there are less rigorous requirements. The database is an excellent source of objective evidence that, for instance, corrective actions were completed and they were effective. The recorded data is sufficient to show the results and efficacy of the Corrective action program. The SBS Q-Med Database was designed for rigorous compliance to FDA standards (21 CFR Part 820 and ISO 13485) with CFR21 Part 11 compliant electronic records and electronic … Continue reading Tech Note: SBS Quality Database and Q-Med Compared
We all know that password management can be a pain in the butt. However, here is a story that may motivate you to update your passwords and keep them strong. http://thehackernews.com/2016/05/linkedin-account-hack.html Synopsis: LinkedIn was hacked back in 2012. 4 years later, 167 million user names and passwords are for sale. The incident proved that LinkedIn stored passwords in an insecure way and that the company did not make it known exactly how widespread the data breach was at the time. Since we cannot completely trust companies like LinkedIn and Facebook to protect our accounts, there are some simple things we must do to minimize risk. I recommend: Change your LinkedIn password (especially if it has not been changed in 4 … Continue reading LinkedIn Hack results in passwords for sale
Elsmar Cove is back online!!!!! For those of you that do not know about the Elsmar Cove Forums, the Cove was started almost 20 years ago as a “chat room” for the discussion of Quality issues. It has grown over the years to be the premier source of information, discussion, and archived resources on the internet. In short is is the “Wikipedia for Quality professionals”. If you need to know something about ISO 9001:2015, post a question on the site and some of the most knowledgeable folks in the world will respond. You could search the entire site and find example spreadsheets, databases, and procedures. Sunday Business Systems was also proud to advertise on the site. Our advertising dollars helped … Continue reading Elsmar is back online!
Last week we had World Password Day. Since all our news networks were busy covering which color carpeting is preferred in Trump Towers, you may have missed it. All joking aside, secure passwords are critical to preventing hacks, protecting company information, and protecting personal information. In a documentary interview, an infamous Romanian hacker said ” 123456 ” was often his first guess when trying to hack and account – and it all too often worked. Your security is important. Secure your data in your Sunday Business Systems Database by using strong passwords. Check out some of the tips on the World Password Day site. The videos from Betty White are funny – listen to her drop an F-bomb: https://passwordday.org/ How do I … Continue reading Secure Passwords
The latest release of the Asset Tracking Database Version 2.6 Is finally here. Officially released 15-Apr-2016. This release incorporates many customer suggestions and improvements. Go to the product page and download the PowerPoint presentation or download a free, full featured Demo and check it out! The Asset Tracking Database is an affordable software tool used to manage calibrated equipment, reduce risk through preventive maintenance, and manage unscheduled maintenance. The program has a rich set of reports including calibration recall lists and preventive maintenance schedules.
There have been some important updates to the Asset Tracking Database. 1. We have a new user interface: The new interface is very simple and intuitive, allowing users to move between modules with fewer clicks. 2. We have automatically re-scheduled PMs and Calibrations. 3. We also have the ability to collect parametric data for each calibration: Calibration data collection is great for devices, such as calipers or gauge blocks, that are calibrated internally. Techs can record the actual measurements, compare them to specification limits, and create a quality record for each calibration event. There is no charge for the latest version of the software. However, we charge $95 to import data from your current database into the new database. The … Continue reading What’s new in the Asset Tracking Database
International Standards bring technological, economic and societal benefits. They help to harmonize technical specifications of products and services making industry more efficient and breaking down barriers to international trade. Conformity to International Standards helps reassure consumers that products are safe, efficient and good for the environment. For business International Standards are strategic tools and guidelines to help companies tackle some of the most demanding challenges of modern business. They ensure that business operations are as efficient as possible, increase productivity and help companies access new markets. Benefits include: Cost savings – International Standards help optimize operations and therefore improve the bottom line Enhanced customer satisfaction – International Standards help improve quality, enhance customer satisfaction and increase sales Access to new … Continue reading Benefits of International Standards