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Jennifer Markarian is manufacturing editor of Pharmaceutical Technology.
Paperless operations improve efficiency and increase assurance of product quality.
Replacing stacks of paper records with easily searched and shared electronic records has clear benefits for both the near and long term, but making the switch requires careful planning and risk management. Pharmaceutical Technology spoke with Ken Kovacs, quality business systems manager at Fujirebio Diagnostics, about the advantages of using electronic production records and the keys to successfully implementing a system.
Electronic-record conceptPharmTech: What are electronic production records (EPRs), and how do they relate to electronic batch records (EBRs)?
Kovacs: Production record requirements are identified in various FDA regulations, such as 21 Code of Federal Regulations (CFR)
Part 211 for Finished Pharmaceuticals (1) and 21 CFR Part 820 for Medical Devices (2). Production records can be considered a collection of all the records required to manufacture an FDA-regulated product as well as all the records produced during the manufacturing of those products to meet specific regulatory requirements. EPRs provide an electronic equivalent to paper production records as required by agency regulations.
The concept of EPRs has not been used as extensively in industry as EBRs. An International Society for Pharmaceutical Engineering (ISPE) special interest group (SIG), the Good Automated Manufacturing Practice (GAMP) Manufacturing Execution Systems (MES) SIG, used EPR as a more universal term to include all associated production records for both pharmaceutical and medical device industries, which is important because of the increasing overlap in these industries (e.g., combination drug-device products). Both batch records and device history records can be considered subsets or components of production records. ISPE’s GAMP 5 (3) and the GAMP Manufacturing Execution System Good Practice Guide (4) provide appendices describing electronic production record systems and associated functionalities, such as ‘review by exception’ and electronic signatures.
Implementing EPRs creates the ability to generate and distribute electronic records within the enterprise in a timely manner, dynamically control processes to decrease product variability, and assure product quality during production. CGMP-compliance issue investigations and their associated paper-based records may also be simplified through information derived from EPR reports. Over time, EPR systems can evolve to provide real-time product disposition and provide a database of scientific knowledge needed for process understanding and future product development.
AdvantagesPharmTech: What have you found to be the biggest advantages of EPRs?
Kovacs: Fujirebio Diagnostics’ current EPR system has saved several thousand hours of people’s time when compared to the previous, manual data-logging process and review of associated paper-based GMP reports. Paper-based logs and reports have been eliminated. Parameter data are automatically logged, analyzed in real time, and retained in a database by the computerized system. Authorized personnel are immediately notified via email in the event an adverse warning or excursion occurs with any monitored parameter, and system functionality allows us to capture personnel comments and electronic signatures by department for each event.
Monthly departmental summary reports (SRs) are generated for ‘review by exception’ and routed via workflow software to each department for review and electronic signature approval. The SRs are then routed to quality assurance (QA) for final review and approval. Once approved by QA, the system generates a monthly electronic SR for each department and appropriately files it for retention and future use. All data and electronic records are routinely backed up through information-technology processes and procedures.
With this system, we now have the ability to more easily analyze equipment and process operations for a better understanding of critical process parameters and product quality attributes.
ImplementationPharmTech: How did Fujirebio Diagnostics go about implementing EPR?
Kovacs: Our executive management team had already identified an electronic initiative as a concept for implementing electronic records. The EPR project team then identified a strong business need for this specific EPR system. A project justification and return-on-investment calculation based on implementing an infrastructure conducive to installing future applied solutions was developed for management review. Based on this strong need and justification, the project was quickly approved. Before developing an infrastructure and architecture, the project team agreed on using International Society of Automation (ISA) ISA95 (5-6) and ISA88 (7) standards and models as guidance for system design.
Personnel from the entire company were engaged to obtain their feedback and expectations for this new system. Twenty-seven individuals from all departments participated in the development of the user requirements specification (URS). This project was truly company-driven by users and management working together.
PharmTech: What were the keys to successful implementation?
Kovacs: Direction from executive management provided the support for launching this project and was crucial to getting this system approved. Project implementation was guided by our formal system development life cycle (SDLC) and a step-wise project management methodology that includes a risk-based approach to design and validation. The use of global standards and models greatly reduced the time needed to define a site-wide architecture and system functionality. Once the URS was completed, a request for proposal package was developed, and leading system integrators (SI) were identified and invited to participate in our selection process. A SI providing what we identified as the best applied solution to address our user requirements was then selected. Deliverables required for each phase of our SDLC were completed as the project progressed.
Before going live with this system, a comprehensive documentation package was completed, robust qualification testing was executed for validation, and more than 60 users were trained. Completion of system validation allowed us to move one step closer to system turnover. After formalizing a system support team and process, the system was then operated in parallel with existing, manual standard operating procedures (SOPs) for three months. Because this was the first implementation of a record system of this type, we wanted to ensure that everyone was properly trained and that everyone understood the process of generating and approving the e-records. In addition to system-level training, we included training on our e-signature and e-record SOP, which is based on 21 CFR Part 11 requirements. The comparison of e-records to paper was integrated in our approach to system qualification for validation. At the end of three months, our user community was comfortable with the new system and was also eager to make the transition to e-records, after seeing how much easier it is to use compared to the time previously spent in manually logging data and reviewing stacks of paper records. Migration to the electronic record system was then made official, with manual activities relegated to a back-up role. Existing SOPs previously used for generating manual logs and paper records will now be used only if there is an operational interruption to the automated system.
During the entire project, timely meetings were conducted with the SI and contractors, team contributors were acknowledged and thanked, and project update bulletins were frequently posted to keep all company personnel apprised of progress being made. This communication was important because the new system was a significant change that affected people in 18 different departments.
Next stepsPharmTech: How does the new infrastructure provide a basis for further improvements to manufacturing equipment systems?
Kovacs: During initial discussions on what an electronic initiative meant to Fujirebio Diagnostics, a ‘future state’ of paperless operations was envisioned and various strategies identified to make it all happen. The infrastructure implemented with our first project was designed to provide an architecture that addresses equipment integration, data acquisition, and information management from the shop floor through manufacturing operations and up to our business systems. System hardware and software products from global suppliers were chosen to provide for easy expansion and compatibility with future applied solutions.
Since this system was originally installed, we have doubled the number of GMP-related equipment that is being monitored, added more electronic record capabilities, and used system information to support other operations and quality processes. We are now scoping out a new project to further expand data acquisition into other areas in manufacturing with added functionality for manufacturing operations management. By implementing an infrastructure up front with capabilities to meet future needs for data management and EPRs, we now have an established step-wise strategic approach to rolling out applications that support our electronic initiative path forward.
1. Code of Federal Regulations, Title 21, Food and Drugs (Government Printing Office, Washington, DC) Part 211, Subpart J-Records and Reports (2014).
2. Code of Federal Regulations, Title 21, Food and Drugs (Government Printing Office, Washington, DC), Part 820, Subpart M-Records (2014).
3. ISPE, GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Feb. 2008).
4. ISPE, GAMP Good Practice Guide: Manufacturing Execution Systems-A Strategic and Program Management Approach (Feb. 2010).
5. ISA, ANSI/ISA-95.00.01-2010 (IEC 62264-1 Mod) Enterprise-Control System Integration - Part 1: Models and Terminology (Research Triangle Park, NC, 2010).
6. ISA, ANSI/ISA-95.00.03-2013 Enterprise-Control System Integration - Part 3: Activity Models of Manufacturing Operations Management (Research Triangle Park, NC, 2013).
7. ISA, ANSI/ISA-88.00.01-2010 Batch Control Part 1: Models and Terminology (Research Triangle Park, NC, 2010).
Article DetailsPharmaceutical Technology
Vol. 39, No. 8
Citation: When referring to this article, please cite it as J. Markarian, “Implementing Electronic Production Records,” Pharmaceutical Technology 39 (8) 2015.