Impact of "Smart" Calibrators and Electronic Records Regulations on Calibration Management Software
Randy P. Paroda and Blaine E. Clapper, N/A
Contents
Abstract
Introduction
General Calibration Management Requirements
Field Data Collection with DPCs
Software Flexibility
Data Authenticity & Data Reliability
Validation
Summary
Abstract (Back to Top)
Over the past decade, thousands of pharmaceutical, biotech, and other manufacturers around the world have implemented calibration management software to schedule and track their calibration events and equipment maintenance. The primary drivers behind the implementations are compliance to FDA regulations and quality standards and increased productivity and efficiency. For those same purposes, documenting process calibrators, or "smart" calibrators, are now being implemented on a large scale.
The popularity of smart calibrators has introduced new challenges to software developers. The software is now expected to communicate with the calibrators to enable truly paperless calibration, while maintaining the flexibility and record tracking capabilities that manufacturers need to accommodate non-process calibrations and to meet regulatory standards. Those challenges are discussed in detail in this article.
Introduction (Back to Top)
FDA cGMPs (current Good Manufacturing Practices), ISO 9000, and other quality standards are driving increasingly stringent instrument calibration requirements. As with other quality-related functions, instrument calibration involves a large documentation and record-keeping component—in other words, a lot of paper. Typical calibration paperwork includes calibration forms, equipment master records for each instrument, history records for each instrument, and S.O.P.s (standard operating procedures) for instrument calibrations and maintenance.
Over the past decade, many companies have implemented calibration database software to assist in the calibration management process, specifically to maintain equipment master and history records for each instrument, and to schedule calibration events. The fundamental goal of using calibration management software is to increase productivity, while reducing the volume of paper records. The database software has not, however, eliminated the need to carry a clipboard, pen, and calibration forms into the field for recording calibration results. That's where the instrument manufacturers come in.
Instrument manufacturers responded to the need for more efficient, paperless calibrations by developing documenting process calibrators (DPC). These DPCs—or "smart" calibrators—automate the field calibration process, including data recording, and eliminate the need for paper-based calibration forms. The next hurdle to overcome, then, is the integration of the calibration management software and the DPCs.
Today, developers are rapidly integrating the wide variety of DPCs on the market with robust software to provide manufacturers with a total ISO 9000 and GMP-compliant solution. The three primary challenges faced by the software developers include:
- Seamless integration of data collected in the field
- Providing software that is flexible enough to communicate with a wide variety of DPCs
- Guaranteeing data authenticity and reliability
The final item includes not only software functionality, but also meeting regulatory requirements, such as electronic signature capability and on-site validation. As is the nature of the software industry, the integration of software and DPCs is progressing quickly and is having a significant impact on the calibration management software industry.
General Calibration Management Requirements (Back to Top)
Historically, general calibration management requirements have fallen into five primary categories: equipment master records, equipment history records, calibration scheduling and recall, reporting, and standards and procedures traceability.
Equipment master records typically contain information about each piece of equipment—a unique ID number, a description of the equipment item, location, acquired date and cost, manufacturer, etc. Schedules for calibration events are also maintained within each master record.
Equipment history records detail what has happened to each piece of equipment over time. At the completion of a calibration event, the details of that event are entered into the history record, and, in many software programs, the next calibration event date is automatically calculated and scheduled.
Automatic scheduling of calibration events and quick recall of scheduled events are standard requirements of a calibration management system.
Reporting is a key function of calibration management software, as it is the primary method for obtaining a clear picture of what has happened and what is scheduled to happen. The various software programs on the market vary widely in their reporting capabilities. Some offer a short list of basic reports, while the most popular programs offer users a long list of standard reports and the ability to create customized reports to meet their organization's unique needs.
The ability to trace standards and procedures used in the calibration process is a major reason companies implement calibration management software, as this is a fundamental requirement of ISO 9000 and cGMP compliance. A calibration management program should make it easy to denote standards and to link standards and calibration procedures to each equipment master record.
The development of DPCs has added a sixth category to the list of calibration management software requirements. The new category is the ability of the software to communicate with DPCs. DPC integration is currently available in the leading software programs and is appearing more frequently on manufacturers' software requirement lists. With this new requirement comes a list of new challenges for software developers.
Field Data Collection with DPCs (Back to Top)
DPCs, or "smart" calibrators, differ from "dumb" calibrators in two significant ways. First, the manufacturers of DPCs have allocated some memory (usually RAM) to allow Calibration Procedures (Tasks) and Calibration Results to be stored internally in the calibration device. Second, they have also provided a hardware interface to allow the transfer of data. Functionality of "smart" calibration devices varies greatly among manufacturers. Some have taken the "multi-meter" approach, enabling the user to calibrate multiple types of devices with the same instrument. Other manufacturers choose to focus on one or two device types. In any event, the range of source/measure parameters can include current, voltage, frequency, thermocouple, RTD, impedance, pressure, or pH.
Blue Mountain offers a ‘satellite' field calibration package for mobile users
In addition to allowing calibration procedures to be programmed through a keypad interface, these DPCs also allow programming through a communication port. In most cases, the hardware interface takes the form of an RS-232 port or a PCMCIA card, both of which lend themselves nicely to integration with calibration management software. The level of sophistication varies greatly among manufacturers. Some transmit and receive ASCII characters, while others use advanced data compression schemes. Error detection (check sums) is used by some to improve data integrity, while others rely solely on the link.
The real value of DPCs is their ability to store, conduct, and document the calibration procedures for multiple equipment items. This ability is the key to paperless calibrations. By storing calibration procedures, the DPC eliminates the need for the technician to carry a written procedure for each piece of equipment. By conducting the calibration event, the DPC virtually eliminates human error. And, finally, calibration forms are no longer required as all calibration results are recorded and stored with the DPC.
In order to encourage the adoption of DPCs, hardware manufacturers make the software drivers available to others under a "partnership" arrangement. Recently, the ISA Field Calibration Technical Committee (FCTC), as one of their efforts, developed an interface standard to simply the software development effort necessary to communicate with calibrators. The resulting software driver is a COM object, which lends itself nicely to many Windows programming languages. Some calibrator manufacturers are now adopting this standard and are providing the resulting COM object to third party developers to allow software integration with their calibrators.
Adopting the COM standard has benefits for both the software integrator and the hardware manufacturer. Assuming an object oriented design philosophy, software integration requires much less effort. Once the initial design to communicate with a specific instrument is complete, modifying the application to communicate with other instruments that support the same interface is greatly simplified. From the manufacturer's standpoint, providing the COM object to developers encourages support for their hardware. Support from third party software applications may be the deciding factor in which calibrator a user purchases. In the end, it's a win-win situation.
Software developers recognize the value that DPCs offer to their customers and are proactively developing seamless communication links between their software and the DPCs. When linked with a software package, the typical DPC-centered calibration process is as follows:
- Calibration procedures and schedules are established and assigned to each equipment item within the calibration management software.
- Each day, the calibration technician uses the software to identify which pieces of equipment are scheduled for calibration. The specific procedures for each item due for calibration are transferred to the DPC via an RS 232 connection.
- Field calibrations are conducted, and the data for each event is stored within the DPC.
- The calibration data is transferred from the DPC to a temporary "holding zone" within the software.
- A technician reviews the data stored in the holding zone, and, upon verification and approval, posts the data to the appropriate equipment history records.
- Finally, the software automatically calculates new calibration due dates, and the cycle is complete.
The DPC-centered calibration process is automated, all-inclusive, 100% electronic, and leaves little or no opportunity for human error.
Software Flexibility (Back to Top)
No two companies are alike in the way they manage their calibration operation. Therefore, a major challenge of software design is to make a product that is flexible enough to adapt to the diverse needs of the marketplace. Historically, calibration management software has been designed to track two types of data:
- Non-process related calibration data—calibration data collected manually from analytical instruments, and
- Traditional process data—manually obtained and recorded calibration data.
DPC-captured process data adds a third data type to the mix. The most flexible and comprehensive calibration management programs will accommodate all three data types.
Widely varying demands manifest themselves first and foremost in the software interface. Many programs are designed with a static user interface, forcing the users to track information and manage their calibration activities the way the software developer feels it should be done. Companies that recognize the importance of flexibility in software will implement a program that allows them to configure the interface to meet their unique needs—renaming fields, hiding unused fields, and configuring picklists, for example.
The need for a flexible interface is magnified by the availability of many diverse DPC models. Each DPC model makes available different calibration procedures, uses different names and labels for data types and procedures, and presents the data in a unique format. Therefore, the onus is on the software vendors to provide an interface that can accommodate a wide variety of DPC models.
Just as important as managing the data within the system is managing the information that the system produces. The ideal system will offer a substantial library of standard reports, and will also allow the users to customize those reports or create their own. Again, this level of flexibility is required given the high variability among DPCs and the fact that manufacturers may have several different models of DPCs in inventory.
Data Authenticity & Data Reliability (Back to Top)
ISO 9000 4.16 states, "Records may be in the form of any type of media, such as hard copy or electronic media." The FDA's 21 CFR Part 11 contains the "Ruling for Electronic Records & Signatures." Each document provides significantly detailed guidelines regarding the definition of records and, specifically, the management of electronic records.
The ISO document states that document control procedures are required for the following:
- How documentation should be controlled
- Who is responsible for document control
- What is to be controlled
- Where and when the control takes place
The FDA expands the ISO document control guidelines by adding the following requirements:
- The ability to apply electronic signatures to electronic records
- The ability to generate hard copies of electronic records
- Audit trails for tracking changes to data
- Documented personnel qualifications
- Validation of the management system
Thus, ISO-registered and FDA-regulated manufacturers that rely on DPCs need to implement a calibration management system that not only interfaces with DPCs, but that also offers thorough, secure data control and documentation capabilities.
One data-tracking tool that all calibration management software buyers should require is an Audit Trail. An audit trail is an uneditable, permanent log of all changes made to equipment master, equipment history and calibration data records, and is especially valuable during ISO or FDA audits. The audit trail should record when a record was added and edited, track old and new values, and show who added or edited records. Some companies also require a reason to be entered for each action that is saved. These should also be recorded in the audit trail.
The advent of DPCs and other field units, such as laptops and PDAs, that make paper records obsolete prompted the FDA to document electronic signature requirements in 21 CFR Part 11. Part 11 sets forth criteria under which the agency will accept, under certain circumstances, electronic records as equivalent to paper records and handwritten signatures. The criteria apply to the recording of calibration results, reviewing and approving the results, and approving changes to the original data.
More specifically, the FDA regulation provides the following electronic signature guidelines:
- Signed electronic records must include the printed name of the signer, the date and time the signature was executed, and the meaning of the signature—for example, review, approval, responsibility, or authorship.
- Electronic signatures must be linked to their respective records to prevent deletion or falsification.
- Electronic signatures must be unique to one individual.
- Electronic signatures not based on biometrics shall have at least two distinct components, for instance an identification code and a password. The first signing in any work period must include both components of the electronic signature; subsequent signings in the same period must include at least one component.
- Controls must be maintained to ensure that each combination of identification code and password is unique, that passwords are changed periodically, that lost or stolen passwords are deauthorized, and that attempts at unauthorized access or signing are reported.
Calibration management software must provide electronic signature capability that is thorough, secure, and traceable to meet this challenge and to facilitate a paperless calibration process that can be validated according to FDA specifications.
Validation (Back to Top)
In FDA-regulated applications calibration management software must be validated. The first step in the validation process is documenting specific software requirements. What are the objectives of implementing a calibration management program, and what software capabilities are required to meet those objectives?
Vendor qualification is the second step. It must be verified that the software vendor can provide a quality product with a high level of integrity that meets the documented requirements.
The third and final step is end-user validation. Such validation is required by the FDA and is recommended in ISO-compliant facilities. This part of the validation process varies widely among organizations. Some require only basic testing and documentation, while others require a very thorough process, where each software function is tested and the results documented.
The DPC interface should be a part of the end-user validation, focusing specifically on the accuracy and completeness of the data that is transferred between the software and DPC. Since little human intervention is required during the actual data transfer and calibration processes, it is crucial that the process be tested and validated prior to plant-wide implementation. Some software vendors make available validation documentation and tools that make the end-user validation process relatively painless.
Summary (Back to Top)
The availability, convenience, and ease-of-use of documenting process calibrators make paperless field calibrations a reality. As the DPCs' popularity increases, so are the demands placed on calibration management software developers to produce software that interfaces seamlessly with the DPCs. However, simply communicating with the DPCs is not sufficient. The calibration management systems are still required to provide a full-range of functions and to meet a long list of regulatory requirements.
Before selecting a calibration management system, organizations should document their needs and vendor requirements. Select a software vendor that has a documented history of providing high quality, thoroughly tested, and validatable software products. Also look for a vendor that quickly adapts to changing regulatory requirements and available technology.
Documenting process calibrators are permanent fixtures in the manufacturing industry. Software that interfaces with and takes full advantage of the DPCs' time-saving features is available. Through careful research and planning, manufacturers can now implement a "closed-loop" management system that will schedule, conduct, and record all facets of calibration activity efficiently and accurately.
References
- Federal Register, 21 CFR Part 11, Vol. 62 No. 54, August 20, 1997.
- Ralph Bertermann, Calibration Manager: Electronic Records and Electronic Signatures, November 1999, p. 10.
For more information: Randy P. Paroda, Director of Product Development, or Blaine E. Clapper, Director of Marketing & Sales, N/A. 206 West Hamilton Ave., State College, PA 16801. Tel: 814-234-2417. Fax: 814-234-7077.
Source: Pharmaceutical Online, sister website to Medical Design Online.