Regardless of industry, companies today strive for higher levels of quality improvement. Movements towards IoT, Big Data and Industry 4.0 initiatives increases the need for better “state of the art” professional management and data driven software solutions. Regardless of past cultural considerations, advancement towards current technologies makes good business sense and crosses all boundaries of vertical markets. Operational cost reductions, improved manufacturing throughout and better product consistency are just a few of the universal outcomes that can be achieved. The degree to which additional benefits can be gained above these generic factors are, in part, in direct proportion to regulatory requirements.

In context for this article, quality is defined simply as current practices, defined protocols, shortcoming assessments and methods for improvement. The first example of a base-line quality certification is ISO 9001. Here individual sections within the quality manual define operational practices, controls and individual role responsibilities. Performance metrics are established, documented and routinely internally and externally audited. Certification demonstrates a degree of operational consistency but does not necessarily point to a statement of value. Calibration procedures and practices are generally defined and subject to change control management. Calibration software is popular here but many also still use old-fashion spreadsheets and paper documents. Industries and types of companies that ascribe to this level of certification included discrete manufacturing, power generation, chemical refining, food & beverage, etc.

Another example of a more focused and stricter regulatory requirement is ISO/IEC 17025 accreditation. This is an international standard established for testing and calibration laboratories. It enables labs to demonstrate their competence in producing valid and reliable results. Unlike ISO 9001, accreditation is not granted to the company as a whole but it is specific for certain types of devices. The accreditation process requires a high degree of technical competence, adequate environmental controls, well trained personnel, and an acceptable infrastructure of highly accurate and routinely certified test standards. Internal and external audits are mandatory and routinely conducted. Internal metrology divisions within companies, government agencies and third-party service providers are typically those organizations with this level of accreditation. Calibration software is essential for accurate record keeping and audit review.

A final example is GMP compliance (Good Manufacturing Practice). This is a standard established by the U.S. Food and Drug Administration (FDA) for FDA regulated companies. The regulations are meant to ensure that pharmaceutical drugs are consistently produced and controlled according to well documented protocols, that they are safe for use and that they provide the intended results. FDA regulated companies must warrant that they adequately control manufacturing operations. This includes establishing strong and robust operating procedures for calibration practices and related documentation. GMP guidelines set by the FDA are just minimum requirements. Flexibility in interpretation allows companies to determine the best methods for implementing the necessary controls and system structure. That said, FDA 21CFR Part 11 regulations under this provision are strict guidelines that define the criteria when paperless electronic records and electronic signatures are used to replace paper-based record keeping practices. Feature rich calibration management software that is pre-validated and categorized as a GAMP COTS 4 is often used and provides the most effective tool to meet these requirements.

To summarize, quality regulations can vary according to industry standards. Regarding calibrations, those standards and regulations may also apply to safety, environmental and other issues. For some industries, internal practices/policies and continuous improvement commitments are discretionary but for others they are mandatory. Listed above are just a few high level examples of possible variations. Some companies fall into a single category. Others, such as large organizations with many sites and/or divisions, product offerings and global locations may be structured to require software that accommodates a combination of two or even all three scenarios. The configurability and scalability of the software makes all the difference. Establishing a user requirements specification that takes into account enterprise deployment objectives and potential application integration plans, as well as management and user needs, is the first best step towards proper software system selection.

Call Now Button