The Evolution of Paperless Calibration Management Software
It’s been Evolution, Not Revolution in the calibration software field as manufacturers continue a never-ending quest for greater functionality.
The environment in which many manufacturing companies operate is one that is very exacting and often subject to scrutiny by internal and corporate auditors, or by regulatory agencies. There is a hierarchy of criticality that is associated with these systems that take into account how directly the operation impacts the product produced.
Nowhere has this scrutiny been more evident than in the case of the Food and Drug Administration’s Code of Federal Regulations (CFR) Part 211 for Finished Pharmaceuticals. This set of regulations was heavily over-interpreted and misunderstood when they first became law in 1997. So much so, that the FDA deployed a guidance document outlining the scope and applicability of 21 CFR Part 11.
“I have been through multiple FDA and European audits, as well as numerous internal and corporate level audits,” says Kevin Grady, founder and CEO of GMP Technical Solutions, LLC , a cGMP/ GLP professional firm based in Stafford, NH that offers Industrial and High-Tech Manufacturers a dependable, high-quality option to supplement in-house Validation, Controls and Calibration resources. “My experience has been that most auditors want to ensure that companies utilize a process of controlling their calibration and maintenance management systems. With the exception of smaller facilities that operate a 100% manual process utilizing Standard Operating Procedures, audi-tors typically ask what application is used. They want to ensure that a suitable level of validation has been performed and documented for the application.”
Software that Facilitates Compliance and Enhances Good Business Practices
On a daily basis, management of critical documentation, communication of requirements and the accurate and timely reporting of results are major undertakings that offer numerous opportunities for error. In addition to regulatory compliance, there are the Good Engineering/Good Business Practices codes that demand that a calibration management system be deployed to monitor the effects of instrument wear or the drift of settings due to mechanical or environmental reasons.
The development of software that addresses these complex tasks, and its proven reliability, has helped to reduce the scrutiny of audits. Manufacturers were equally happy to discover software that offered audit trails and security.
Over the past eight years, several products have emerged to fill this critical need. The most popular of these meet the basic criteria of providing the procedures, security and audit tracking necessary to facilitate government, industry and other compliance requirements. The driving force behind manufacturers’ move toward the so-called paperless systems went one step further toward making compliance a manageable issue.
Voridian Chemical Goes Paperless
When Voridian Columbia Operations, a division of Eastman Chemical Company, decided to go paperless using the latest generation of ProCalV5, its intention was to optimize a lean calibration staff.
“I’ve been to our calibration shop on a number of occasions, either as part of a customer visit or audit, and have had a chance to observe our use of the ProCalV5 software,” says Brian Lander, Manager of Quality Assurance for Voridian. “It offers a number of benefits.”
“Calibration reports show the test instrument used and reference the current calibration status of the test instrument. Reports are easy to save and e-mail as PDF files, which has cut down on the amount of paper we handle.”
“We are able to link our specific procedures which are stored on a local server to the informa-tion used when calibrating instruments. In addition, the system interface is extremely flexible which allowed us to have the software fit our existing processes rather than having to re-think our processes to fit the software. Calibration records are easy to retrieve several different ways.”
ProCalV5 is a key element of the Voridian Calibration Lab’s part in its ISO 9001 quality man-agement system. The flexible and intuitive data retrieval and reporting capabilities, along with elec-tronic data collection, helps Voridian make its lean calibration staff completely effective. “Our central-ized shop is subject to examination in any internal, customer, or 3rd party audit,” says Landers. “Auditors now leave the Calibration Lab very satisfied with the effectiveness and efficiency of our calibration processes.”
Quality, Functionality, User Friendliness a Key
The users of today’s calibration software require that in order to be acceptable any product they use should meet a myriad list of needs. First and foremost is quality. The application must meet quality guidelines of record retention, stability, security and all aspects of a site’s operation. Very often, any deficiency in these areas will cause the application to be disqualified as a potential solution.
Where the line is drawn between the acceptable industry standard and the exceptional prod-ucts varies with the needs of the customer. At the engineering and administrative level, functionality is often the issue over user-friendliness. These groups typically seek a solution that is highly-configurable and one that has multiple levels of security to administer the process with the highest degree of con-trol.
“Today’s customers, especially at the larger organizations, want functionality that literally reduces head count and increases productivity,” says Kevin Grady.
While administrators and engineers emphasize functionality in calibration software, technicians and supervisors seek user-friendliness in an application. Most want an application that mirrors the manual method, although this has proven to be one of the most elusive elements for software producers.
Increasing calibration efficiency was also the driving force behind John Kuehl’s recent decision to purchase ProCalV5 software for Cangene, a world leader in the development, manufacture, and commercialization of specialty hyperimmune plasma and biotechnology products. In addition to the technology, our choice had a lot to do with the expertise of the people behind the product,” explains Kuehl, who is Manager of Controls/Metrology for Cangene. “This was reinforced by the 30 day demo they provided. It was well designed and helped assure me that the product would meet our needs for many years to come.
“The fact that ProCalV5 is so easy to use is a credit to the designers,” says Kuehl. “It tells me that a lot of thought and work has gone into the product and that is very reassuring.”
A Matter of Administering the Application
“The effectiveness of the software application is to no small degree dependent on good adminstration and management,,” explains Prime Technologies’s Nick Volpone. ”The foundation of the compliant system is the establishment of the required quality, business and engineering practices. The communication of these practices is accomplished through procedural definition and user training. It then falls to the administrator to configure the application to insure they are followed. Administrative practices must be in place that address these critical issues.”
Administrative procedures are the basic requirements of the calibration system that outline many activities including the planning and documentation of calibration activities, review of calibra-tion data/records, notification and reporting of out-of-tolerance occurrences and other out of compli-ance events to those responsible. QA review/approval of procedures, Change Control of Item Master Records and other general calibration requirements. The paperless calibration system gives manage-ment the information and tools needed to direct, accomplish and oversee the calibration program.
Conveniently accessible from the paperless system, instrument/device specific procedures outline the calibration of the applicable instrument or category of instruments, and provide the techni-cian with guidance and instruction on the calibration steps for that instrument. Important steps to be outlined in these procedures are the documenting of as-found and as-left data, instructions on how adjustments are made, ensuring that accuracy and repeatability checks are performed and specifying the desired number of calibration points to be tested. It is also important for users to consider an instrument/device-specific procedure to be created for each instrument type (e.g. pressure indicator, temperature indicator, flowmeter, etc.), and one which can be manufacturer brand-specific.
The process of internal/external calibration technician or contractor qualifica-tion should be outlined in a procedure. It is essential to document the qualification, education, train-ing and experience of the technicians performing calibrations. Individual training files should be established containing a resume or curriculum vitae, a qualification assessment memorandum, an approved job description, a job curriculum, a training matrix and any applicable training certificates or licenses. The job curriculum and training matrix outline the procedures that the individual requires to be trained on to perform his/her job effectively, as well as the progress of such training.
Calibration standards are likewise managed and documented to ensure that the instruments to be calibrated are tested with a standard of higher accuracy, they must be traceable to NIST or other recognized standards organization. Calibration standards are typically sent out to ANSI/NCSL Z540 and ANSI/ISO 17025-certified laboratories, are certified, and then returned with documented evidence of such certification. They must be handled with care and properly stored/secured. The accuracy ratio of the standard to the device should be a minimum of 1:1, but 4:1 is the preferred ratio. Uncertainty calculations, guard banding and other calibration practices are much easier to archive once the paperless solution is in place.
Instrument calibration change control is defined as documentation of the complete instrument history, encompassing the time period from when the instrument was first added to the system up to the time the instrument is decommissioned or deleted from the system. The instrument calibration change control form typically includes static instrument description information, classifica-tion, calibration interval, calibration limits/tolerances, clarification of test points, and any special instructions or comments to help facilitate proper calibration of the instrument. This important manage-ment and technical documentation is now completely managed within the more advanced software with provisions for approval routing, electronic signature and full audit trail record.
Other calibration documentation/records include tagging, calibration reports and instrument files. Instruments are tagged with unique identification numbers, as well as stickers that pro-vide a local indication of calibration status (e.g. calibration pass/fail or out of service). Instrument cal-ibration reports are documented evidence of the calibration including as-found data, as-left data, stan-dard information, pass/fail indication and appropriate review signatures. Instrument history files con-tain electronic records of calibration reports and calibration change control forms. These files repre-sent the calibration and repair history of the instrument and serve as the documented evidence of cali-bration. They are frequently reviewed and scrutinized by auditing bodies. Whether for auditing or performance evaluation access to these records are easily facilitated within the ProCalV5 system.
Providing the Incentive to Change Is all this sufficient to encourage companies to make the change from clumsy manual systems or less than ideal paperless systems? With an electronic system, users can see where their vulnerabilities are; e.g. what is overdue in terms of the schedule for repairs. Queries and reports can be easily run. That is difficult to do and see on a paper system. This feature allows users to better assign strategies and resources for addressing overdue items, frequency of calibrations, and other factors. The system alerts users. In addition, for those users who outsource calibrations, it permits invoicing to be done in a much more timely fashion. The client user can run reports that show exactly which instruments were calibrated “By centralizing a system, you become more of a global entity,” adds Nick Volpone. “It makes practices much more uniform and standard.”
Further Evolution While industry experts point to many developments in calibration management applications in the years to come, there are three areas that emerge as likely for development.
* As wireless networks become more secure, reliable and common, paperless calibration solutions minimizing the traditional process of record exporting and importing will become more important. Essential to this will be the integration of compliant solutions through more user-friendly interfaces, like handheld field calibrators and portable PC’s utilizing operating systems that are more sophisticated than today’s traditional units.
* Experts see an increased focus on the presentation layer and less focus on the back-end stability and compliance layer. The systems are virtually 100% compliant and small changes are easily incor-porated. The focus needs to shift to a field where the true work is done.
- * Enterprise solutions are likely to be a hot button. Companies are striving to save money and central-ized solutions are very common now with applications like SAP and Data stream. To date there has been very little in the way of enterprise calibration systems that incorporate hundreds of thousands of instruments utilizing centralized servers that house and process all the data in one location while main-taining communication functions. The integration of a paperless calibration solution like ProCal with the ERP or CMMS systems has been proven to be an effective way for companies to benefit from the best of both.
Today’s leading calibration software manufacturers will, most likely, be in a good position to capitalize on these trends. And, if the future reflects the present, than calibration management soft-ware will continue its quiet evolution, offering users more and more functionality.