Insights Into Laboratory Compliance and IT Services

INSIGHTS INTO LABORATORY COMPLIANCE AND IT SERVICES Laboratory Compliance and IT Services: eBook Table of Contents Foreword���������������������������������������������������������������������������������������������������������������������������������������������������3 Advancing Laboratory Compliance with Integral Laboratory Services��������������������������������������4 [Infographic] System Lifecycle Support: Optimizing Laboratory Compliance���������������������������7 Understanding Your Data Integrity and Computer System Validation Needs in the Pre-Clinical Development Laboratory����������������������������������������������������8 [Infographic] Data Integrity Is At The Heart Of Laboratory Compliance����������������������������������11 Your Compliance Journey with PerkinElmer OneSource Services����������������������������������������������12 Discover the Potential of PerkinElmer OneSource Information Technology Services (IT) ����������������������������������������������������������������������������������������������������������������������14 Resources������������������������������������������������������������������������������������������������������������������������������������������������16 3 Ensuring product quality and safety is of utmost importance across multiple industries, including pharmaceutical, food and beverage, environmental, chemical and clinical diagnostics. To achieve this, regulated laboratories must diligently follow the compliance requirements set by regulatory agencies. Achieving lab compliance, however, is a challenging task involving various elements such as software validation, data integrity, equipment qualification, calibration, maintenance and repair, as well as personnel training and documentation. For many labs, taking care of all these tasks leads to decreased productivity and less time dedicated to crucial scientific activities. Consequently, many companies turn to external services to help them navigate evolving regulations. In this context, comprehensive laboratory services are increasingly embraced by labs of all sizes and types. By partnering with a single provider, companies can streamline their compliance efforts, eliminating the need to manage multiple service providers, reducing administrative burdens and minimizing the risk of errors. The purpose of this eBook is twofold. Firstly, it aims to highlight essential concepts related to lab compliance, data integrity and software validation. And secondly, it discusses the benefits of partnering with PerkinElmer’s OneSource Laboratory Services, which offers comprehensive and customized end-to-end solutions to ensure compliance and to maximize productivity. Foreword FOREWORD 4 Laboratory compliance involves adhering to a range of requirements set by regulatory groups including government agencies, industry associations and accreditation bodies. These compliance measures comprise a set of procedures and policies carefully developed to guarantee the accuracy and reliability of lab-generated results. Additionally, quality management systems (QMS) help to establish processes for quality control, document control and staff training as well as to monitor laboratory performance. Hence, laboratory compliance and QMS are indispensable for regulated labs to ensure the reliability of results while standards are met.1 This is critical for a wide range of industries where product quality and safety are of utmost importance (including pharma, food, beverage, environmental, chemical, clinical diagnostics, etc.). Laboratories often rely on various external services to achieve compliance. This includes support for software validation, qualification, the calibration and maintenance of equipment and personnel training. Integral specialized laboratory services, which provide a comprehensive suite of solutions, are becoming increasingly popular among laboratories of all types and sizes. Essential compliance requirements: a comprehensive overview GxP guidelines Regulatory compliance is essential for ensuring product quality as well as maintaining data integrity and laboratory personnel safety. GxP encompasses several guidelines, such as good laboratory practice (GLP), good document practice (GDP), good manufacturing practice (GMP) and good clinical practice (GCP). These guidelines cover a broad range of activities, including design, development, manufacturing, testing, distribution and maintenance of products. They also apply to facilities, equipment, personnel and documentation used in these activities.2,3,4 Additionally, process validation and equipment qualification regulations are included, to ensure that all aspects of the production process are controlled, documented and validated. GMP states that all manufacturing equipment, utilities and facilities must be properly validated, verified, qualified and calibrated. Understanding these terms and their differences is crucial to ensuring that laboratory operations meet regulatory requirements and produce accurate and reliable results. Validation and verification are often used interchangeably; however, they represent different aspects of lab compliance. Validation refers to a documented process to establish that testing methods, manufacturing processes and software are suitable for their intended purpose.1,5 This is typically used to challenge the performance of a new method/process/software before it is put into routine use in the laboratory. Verification, on the other hand, refers to the confirmation that a previously validated testing method is suitable for a given use under specific experimental conditions.1,6 Qualification is mainly used for instruments and ensures that lab equipment is properly designed (Design Qualification, DQ), correctly Advancing Laboratory Compliance with Integral Laboratory Services ARTICLE 5 installed (Installation Qualification, IQ), works as expected (Operational Qualification, OQ) and is fit for the intended purpose (Performance Qualification, PQ).7 Finally, calibration refers to the process of comparing the measurements obtained from a device to a known standard to ensure that the equipment is functioning correctly.1 Data integrity Regulatory agencies – such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Japanese Ministry of Health, the Health Canada and the China Food and Drug Administration (CFDA) – have specific guidelines to ensure the integrity and security of data in the medical industry. For example, the specific requirements of the FDA and EMA are compiled in the FDA Title 21 CFR Part 11 document and the EMA Annex 11. Their key requirements stipulate that regulated labs must maintain electronic records in a secure and reliable manner to ensure their authenticity, integrity and confidentiality. Moreover, electronic signatures must be unique, secure and verifiable to guarantee that they are the equivalent of handwritten signatures. Further, electronic systems must be validated and have an audit trail documenting all changes to electronic records and electronic signatures. Electronic systems must have appropriate security controls in place to prevent unauthorized access, modification or deletion of data. Electronic records and signatures must be available for inspection, review and copying by authorized personnel. By complying with these guidelines, labs can ensure that their electronic records and signatures are legally equivalent to paper and handwritten equivalents. This allows them to maintain the highest standards of quality, safety and efficacy. Good Automated Manufacturing Practice 5 (GAMP 5) GAMP 5 guidelines have been developed by the International Society for Pharmaceutical Engineering (ISPE) to ensure that pharmaceutical products are manufactured in a consistent and reliable manner using automated systems. This is a risk-based approach to compliant GxP computerized systems that provides practical guidance for the entire lifecycle of automated systems, from design and development to testing, operation and maintenance. The main objective of GAMP 5 is to ensure that computerized systems are fit for their intended purpose, meet regulatory requirements and consistently produce safe and effective products. Although it was originally created for the pharmaceutical industry, it has also been adopted by other industries, such as food and beverage, cosmetics and medical devices. Ensuring quality with computer system validation Violations to data integrity requirements are a common failure in FDA audits.8,9 This problem can be mitigated by implementing a robust computer system validation (CSV). CSV is part of the GAMP guidelines and involves processes to test, validate and formally document that computer systems – including software, hardware and associated infrastructure – are designed, developed, tested and maintained in a manner that meets regulatory requirements (including those set in FDA Title 21 CFR part 11 and EMA Annex 11).10,7 This type of validation is different from the IQ/OQ that vendors typically supply with instruments. Instead, it is a custom validation solution that must align with the particular validation policies of each company and the intended use of the instrument. CSV involves several customized steps, including, planning, testing and documentation.10During the planning phase, the system requirements are identified and a plan for the system configuration and validation is created. This plan includes a risk assessment to identify and mitigate potential issues related to the system’s compliance with regulatory requirements. Next, the system is tested to confirm that it works as expected and meets all regulatory requirements. Finally, a validation summary report is created documenting the complete validation process. The role of universal support services There are several scenarios in which labs need to consider CSV. For example, every time labs acquire new equipment or relocate it to a new facility, the instruments need to go through CSV before they can be released for use. Labs also need re-validation to keep up to date with regulations and best practices. Re-validation might also be necessary after mergers and acquisitions, as well as after inspections by a regulatory agency (a high percentage of the observations made by regulatory agencies are linked to data integrity and thus require CSV to remediate). Finally, any change in infrastructure that impacts lab systems could trigger the need to re-validate (e.g., implementation of new data management infrastructure, security, networked data archive, operating systems upgrades). Implementing CSV and overall compliance is not always straightforward; and labs face several challenges and pain points. The burden of validation often falls on the end user – typically a scientist – whose core responsibilities require the prioritization of other duties. Moreover, internal validation processes are complex, requiring precise technical expertise and several months to complete. In sum, most labs lack the internal bandwidth to commission new systems. Thus, it is The risks of non-compliance Compliance with GxP guidelines and other regulations is crucial for labs’ success and operational integrity. It guarantees that their products are safe, effective and meet the required quality standards. It also helps avoid costly re-testing, product recalls, regulatory penalties and damage to their reputation.2 The cost of non-compliance in regulated laboratories can be particularly high, given the potential impact on public health and the environment. Non-complaint facilities can face significant fines and penalties and also be exposed to legal liability. Further, loss of accreditation and reputational damage can have a long-term impact on the lab’s ability to attract clients and partners. Therefore, it is important for laboratories to take compliance seriously and implement effective programs to minimize these risks. 6 common that new instruments don’t get commissioned and remain idle, failing to exploit their potential. By partnering with a single service provider, companies can streamline their compliance efforts, including equipment qualification, calibration, maintenance and repair, as well as training and documentation support to meet changing regulations and gain back time for scientific innovations. This approach eliminates the need to manage multiple service providers, reducing administrative burdens and minimizing the risk of errors. PerkinElmer’s OneSource Laboratory Services offer a customized, cohesive, end-to-end solution for regulated labs. The comprehensive suite of services provides the knowledge, applications and manpower necessary for modern labs. This includes uptime optimization, lab analytics and workflow solutions regardless of your instrument supplier. As laboratory regulations and standards continue to evolve, integral laboratory services will become increasingly important for laboratories seeking to maintain compliance and ensure accurate and reliable test results. Maximize the efficiency of your lab by partnering with PerkinElmer OneSource today. References 1. Laboratory compliance: Making the grade. Laboratory News. https://www. labnews.co.uk/article/2029065/laboratory_compliance_making_the_ grade. Published: 11 September 2008. Accessed: 25 May 2023. 2. Kanten C, Kanten D. Understanding GxP compliance in the lab. LabManager. https://www.labmanager.com/big-picture/data-integrity-security/ understanding-gxp-compliance-in-the-lab-25558 Published: 16 April 2021. Accessed: 25 May 2023. 3. Compliance: research and development. European Medicines Agency (EMA). https://www.ema.europa.eu/en/human-regulatory/researchdevelopment/compliance-research-development. Accessed: 25 May 2023. 4. Current Good Manufacturing Practice (CGMP) Regulations. US Food and Drug Administration (FDA). https://www.fda.gov/drugs/pharmaceuticalquality-resources/current-good-manufacturing-practice-cgmpregulations Updated: 19 May 2023. Accessed: 25 May 2023. 5. Differences between Verification, Calibration and Validation. Lab-Training.com. https://lab-training.com/differences-verification-calibration-validation/. Published: 8 December 2017. Accessed: 25 May 2023. 6. Porter DA. Qualification, validation, and verification. Pharmaceutical Technology. 2007;31(4) https://www.pharmtech.com/view/qualification-validationand-verification 7. Bansal SK, Layloff T, Bush ED, et al. Qualification of analytical instruments for use in the pharmaceutical industry: a scientific approach. AAPS PharmSciTech. 2004;5(1):E22. doi: 10.1208/pt050122 8. Morgan-Linnell SK, Stewart DJ, Kurzrock R. U.S. Food and Drug Administration inspections of clinical investigators: overview of results from 1977 to 2009. Clin Cancer Res. 2014;20(13):3364-3370. doi: 10.1158/1078-0432.CCR-13- 3206 9. FDA issues warning letter due to severe violations of data integrity. ECA Academy. https://www.gmp-compliance.org/gmp-news/fda-issueswarning-letter-due-to-severe-violations-of-data-integrity. Published: 10 November 2021. Accessed: 26 May 2023. 10. Singh A, Singour P, Singh P. Computer system validation in the perspective of the pharmaceutical industry. J Drug Deliv Ther. 2018;8:359-365. doi: 10.22270/ jddt.v8i6-s.2102 7 SYSTEM LIFECYCLE SUPPORT OPTIMIZING LABORATORY COMPLIANCE In the high-tech world of modern science, more and more time must be devoted to the maintenance and regulatory compliance of instruments and computer systems. For many labs, this means a loss of productivity, and less There’s so much more to commissioning an instrument than just validation, especially for regulated laboratories that require their equipment to undergo computer system validation (CSV). PerkinElmer OneSource can support you at every stage, ensuring that your lab is, and stays, compliant. WITH YOU EVERY STEP OF THE WAY PerkinElmer’s OneSource® Laboratory Services offers a complete suite of solutions to provide the knowledge, services and manpower today’s labs need to maximize productivity. EVALUATION SYSTEM INTEGRATION INSTALLATION VALIDATION • Contact vendors & obtain quotes • Assess 21 CFR Part 11 & data integrity compliance • Evaluation of suppliers • Issue purchase order • Introduce into maintenance program & other asset management systems • Audit trail review and periodic review processes • End-user training • Release for use communication • Creation/ optimization of documents • Computer system validation (CSV) • Verify 21 CFR Part 11 compliance • • Standard operating procedures for administration • Location identication • Utilities verication/facilities & EHS coordination • IT integration ₒ Scheduling vendor install, IQOQ, training ₒ Asset tags ₒ ₒ Change control management SYSTEM OPERATION • System compliance maintenance • Periodic reviews/audit trail reviews • Change control and revalidation management • • SOP creation & revisions and other technical writing • Corrective/preventive actions (CAPAs) and miscellaneous RETIREMENT • • • Retirement protocol and summary report • Computer decommissioning Our experts can give support remotely or on-site, on both standalone and networked enterprise systems. No lab is too large, or too small; PerkinElmer OneSource is fully scalable, from small projects to large managed service programs. A WIDE RANGE OF EXPERTISE compliance specialists deployed at customer sites qualications executed CSV projects completed >40 >10,000 Optimize your laboratory today. >1000 Our knowledge and experience span multiple industries, so you will always get expert support, no matter your specialty: PHARMA/ BIOPHARMA FOOD ENVIRONMENT INDUSTRY NEEDS IDENTIFIED SYSTEM COMMISSIONED Ranging from service contracts for a single instrument to comprehensive management of a complete instrument portfolio, PerkinElmer OneSource offers a wide range of solutions, whatever your requirements. Multiple contract options ensure all your most critical instruments are maintained from day one, keeping your lab running at peak performance. CRADLE-TO-GRAVE INSTRUMENT SUPPORT INSTRUMENT FLEET MANAGEMENT PROFESSIONAL LAB SERVICES ASSET MANAGEMENT COMPLIANCE SERVICES SCIENTIFIC SERVICES ASSET ANALYTICS INFORMATION SERVICES RISK & CONTINUITY Consolidated Servicing Centralized servicing & repair, inventory and full life cycle management Instrument service data, utilization, redundancy and predictive analytics Lab computing, manufacturing execution systems (MES). Empower & OS upgrades Business continuity/ disaster recovery (BCDR) planning, project managed lab relocation and onboarding services External compliance support for areas such as CSV, data integrity, technical writing and method validation Scientic application services, general lab support, lab efciency consulting and concierge services Regulatory Guidance and Support Scientic Support Data Rich Insights Lab Information Systems Support Business Interruption Support • New instruments • Instrument replacement • New analytical methods • Enhanced instrument or software capabilities • Non-compliant systems [Infographic] System lifecycle support: optimizing laboratory compliance 8 Introduction Throughout the 2010s, the data integrity of computerized systems became a foremost concern for regulatory agencies such as the U.S. Food and Drug Administration (FDA). Data integrity is not a new requirement per se. Principles from the paper and ink era carry over, and electronic-specific enforcement within the U.S. began as far back as 1997, with the FDA’s final rule for “Electronic Records and Electronic Signatures”. However, pharmaceutical and life sciences companies now face heightened scrutiny over their practices in documenting their electronic processes and in managing that data across its entire lifecycle. PerkinElmer realizes these challenges faced by the industry and has created a solution portfolio including OneSource Laboratory Services to aid in the preservation of data integrity as well as in compliance with requirements for computer system validation (CSV), metadata retention and audit trail management. The stakes for proper data integrity are high, as it is a common violation in drug current good manufacturing practice (cGMP) letters from the FDA. In fiscal year 2018, 57% percent of all such warning letters cited deficiencies in data integrity. That is down from a peak of 79% in 2016. The same year the FDA released its draft guidance for “Data Integrity and Compliance with cGMP,” which was later finalized in late 2018. The U.K. Medicines and Healthcare products Regulatory Agency and the World Health Organization also issued similarly significant guidance during these years. Looking ahead, lab efficiency and compliance must remain priorities as agencies continue to update their data integrity regulations. Solutions including PerkinElmer OneSource help put both data integrity and the closely associated CSV on sustainable trajectories. Data integrity: Understanding current requirements and best practices The FDA currently sets the bar for data integrity at “complete, consistent and accurate” and the agency regards the associated compliance as integral to cGMP as well as public health. Its ALCOA acronym – Attributable, Legible, Contemporaneous, Original, Accurate – provides some additional context on what is expected from pharma personnel throughout processes for research, pre-clinical drug discovery and development. OneSource is designed for full ALCOA compliance. At a fundamental level, data integrity requirements promote the accuracy and reliability of all data produced by FDA-regulated entities. Compliance with them in turn supports cGMP, resulting in safer, more effective products with fewer defects and less likelihood of recall. Lapses in data integrity may take many different forms, including falsifying results and failing to fully document every process; but, in all cases, they pose a risk to the public since they compromise the safety and efficacy of the drugs in question. For pharmaceutical firms, failure to preserve data integrity endangers their relations with the FDA – leading to warning letters and possible license revocation – and also creates substantial cybersecurity risks, as the concepts of data integrity and data security are intertwined. In fact, missing and/or corrupted data is often the by-product of not having adequate access controls (e.g., robust authentication during logins), which are pivotal FDA data integrity requirements alongside proper retention of metadata and the creation of audit trails. Understanding Your Data Integrity and Computer System Validation Needs in the Pre-Clinical Development Laboratory ARTICLE 9 Data integrity is part of the basic fabric of pharma processes and accordingly it must be regularly reviewed and validated. While an exhaustive list of the best practices for accomplishing these tasks is beyond the scope of this paper, a few of the key ALCOA-centric examples include: • Implementing username and password requirements to control access and prevent values from being deleted or modified by unauthorized users such as terminated employees. • Recording all changes to computerized data in audit trails. This should include details about who made the change, when it occurred and what previous entry it affected. • Making sure raw and source data is available either in its original form or in a true copy. • Keeping data in a readable and permanent format throughout its entire lifecycle. • Configuring backup systems to prevent any inadvertent data loss or deterioration and to preserve all contextual metadata. • Validating systems through data collection and analysis to verify that they can produce repeatable results consistent with established parameters. CSV is essential to governing the computerized systems involved in these actions and to data integrity as a whole. Computer System Validation: How to pursue CSV at the pre-clinical stage Like data integrity, CSV is a broad concept that affects virtually every dimension of pre-clinical research and drug discovery. It touches many technologies and involves numerous teams within a regulated company. Together, these teams bear responsibility for proper CSV and, by extension, for organizational compliance with regulations on data integrity. Beyond the lab itself, departments such as IT will be needed to help with the configurations, permissions and settings necessary for proper CSV. The central purpose of CSV is to verify that a system, such as a lab instrument or software application, does what is expected – in terms of producing acceptable information – as defined in its parameters. Essentially, CSV proves that the system can withstand scrutiny. A properly validated system will create information that is accurate, consistent, reliable and human-readable. In OneSource, there is support for corrective actions including CSV, with a basis in 21 CFR Part 11 and GAMP 5. GAMP 5 is the common standard for CSV. Short for Good Automated Manufacturing Process, GAMP 5 is explained in detail in the document “A Risk-Based Approach to Compliant GxP Computerized Systems”. Although it is not an FDA requirement, GAMP 5 is widely used and offers a comprehensive framework for evaluating different categories of hardware and software, including infrastructure software, configured products and custom applications. A GAMP 5-adherent CSV process typically starts with activities such as a GxP impact assessment to see if the system affects product quality and safety and an electronic records and signatures review to determine if it creates and maintains those specific assets. Subsequent steps may include conducting risk assessments, collecting user requirement specifications and periodically evaluating the system’s validated status. CSV is an ongoing process, not a one-time activity; it will extend all the way through the eventual decommissioning of the affected instrument or application. Its time-consuming nature may require outsourcing and expert assistance to keep the process on track. PerkinElmer assists with GAMP 5-CSV of lab instruments and software, opening a more straightforward path toward lab-wide compliance that covers data integrity and maintenance of audit trails for GxP systems. With OneSource, it is possible to perform a full validation of a new system or, alternatively, update the control validation for any enterprise or standalone systems. Audit trails and metadata: Preserving data and context about pre-clinical activities The FDA and similar regulatory bodies around the world have set specific requirements for audit trail creation and metadata retention. Along with CSV, these two activities are essential components of data integrity. Audit trails An audit trail is a computer-generated history of all activities associated with an electronic record, including its creation, modification and deletion. Other events recorded in an audit trail may include overwriting, backdating and testing into compliance, any of which could be signs of data integrity violations. For electronic data, an audit trail should begin as soon as the data is written to durable storage. In addition to being computerized and automated, a compliant audit trail must also be secure, timestamped in accordance with an unalterable clock, traceable to the person(s) who made each change and retained for as long as the record it corresponds to is being held. The purpose of an audit trail is to preserve a record of regulated activities and to keep tabs on how they affect product safety and quality. The FDA’s 2018 guidance on data integrity states that audit trails should be reviewed after each significant step in a drug’s manufacturing, processing, packing, or holding. Periodic reviews of audit trails are important measures for knowing who is accessing key data and what they are doing with it. Along with cybersecurity measures like access controls, they contribute to stronger data integrity. Metadata Metadata refers to the contextual information needed for understanding data; it could be described as data about data. It might indicate who performed a test, when they did it and the relevant instrument and user IDs. Lab software will collect some of this information automatically, making it easier to build out audit trails and ensure electronic records are more accurate than a traditional notebook. 10 Metadata relationships to data should be preserved in a traceable, secure way. Electronic cGMP data should include corresponding metadata, as should any backup created as a true copy of an original. Ultimately, metadata retention is another measure that supports superior data integrity, by filling in context and revealing any gaps that might be cause for concern about a product. Through OneSource, lab teams can more efficiently manage the necessary documentation and preserve metadata for data integrity. Mitigating the common risks to compliance during research and pre-clinical discovery Although there are numerous processes in place – both in and out of the lab – for preserving data integrity, significant risks to regulatory compliance still remain. For example, an instrument might technically be validated, yet no one has reviewed that validation. Similarly, highly siloed validation workflows can leave out the input and expertise of important personnel. Related dangers include complex, multi-site setups with a variety of procedures and requirements across them that can lead to inconsistent data management and incomplete audit trails. As the FDA and others have ramped up scrutiny of data integrity, they have identified these issues, along with others including “test to pass” schemes. One such example was documented in 2017 at a facility in Gujarat, at which personnel were repeatedly running purity tests until they got the desired readings. Mitigating these risks requires a combination of the right company culture, in which everyone understands their compliance-related responsibilities and expectations, and suitable technical solutions. A central consideration on the road to compliance is whether performing the necessary activities in-house or via an outside partner will yield optimal results. On the surface, it can seem more economical to go it alone and avoid the costs of outsourcing. However, this route comes with the risk of not having access to the most comprehensive expertise on FDA regulatory compliance at critical junctures, or of seeing an essential system possibly become unavailable. Those events could be much more costly than seeking professional assistance. OneSource professional services help streamline the commissioning and validation of lab instruments (either by automated or paperbased qualification process), as well as other activities contributing to full compliance with rigorous data integrity and CSV standards. PerkinElmer has technical and practical experience assisting regulated companies in these domains, and our team is committed to helping yours navigate pre-clinical compliance. Request more information 11 [Infographic] Data integrity is at the heart of laboratory compliance 12 Labs’ productivity can be slowed down if processes are found to be non-compliant. Consequences can include lost time, fines, product recalls and staff attrition. Yet, navigating the complexities of compliance requirements is not easy. By using integral compliance services, labs can address a variety of compliance challenges. It gives them access to a library of custom qualification documents and methods, as well as a team of trusted consultants with real expertise in qualification, requalification, risk management and remediation. OneSource laboratory services offer an approach that makes compliance simple by harmonizing all protocols under a single Universal Operational Qualification framework. In this way, labs obtain a comprehensive, automated approach to testing, documentation and compliance, streamlining processes across all major models of laboratory instrumentation, regardless of vendor. PerkinElmer OneSource validation and compliance services work in close collaboration with the team providing lab IT services. Together they ensure the delivery of a customized and complete end-to-end solution for the full lifecycle of any lab instrument (from commissioning to retirement). In this interview, Josh McWilliams, product manager for GxP validation and compliance services at PerkinElmer, discusses some of the common challenges in computer system validation and the benefits of partnering with PerkinElmer in this field. Q: What are the usual challenges that pharmaceutical companies face when it comes to computer system validation (CSV)? How can such challenges be addressed? A: Pharmaceutical companies have to address an increasing number of regulatory requirements across different geographies, business activities and functions. Regulatory changes in recent years have led to increasing pressure on companies to just ensure they’re facilitating the right level of compliance for their labs and technologies. Compliance failures can be costly in terms of fines, remediation costs and damage to the reputation. Therefore, identifying, analyzing and mitigating compliance risks is essential for developing an effective compliance program and securing future value. One of the main challenges that labs face is identifying the proper resources to perform a computer system validation project. For example, the validation is typically assigned to the system owner, but this person – usually a scientist – is often overburdened and has competing priorities such as bench work. They can’t complete their work because the instrument is not available for use until the validation has been completed. Thus, to overcome these challenges, lab managers within the pharmaceutical and life sciences industry are turning to external partners like PerkinElmer OneSource to validate their systems and transform compliance strategies from cost to value. Q: Some customers may feel that using an outside vendor for CSV would take longer due to delays and the availability of the vendor. What processes do you have in place to ensure a trouble-free customer experience? A: Our solution is tailored to the customer’s validation policies and their software development life cycle (SDLC). We use each customer’s Your Compliance Journey with PerkinElmer OneSource Services INTERVIEW 13 validation deliverables or templates and, if they don’t have them, we can utilize our custom validation templates for the project. We draw upon our experience to understand and work within their validation policies. Our validation specialists have access to subject matter experts with experience in a multitude of instruments and software from different vendors. Also, we’ve done thousands of validations over the years, so we have a large knowledge base to leverage. We use our processes and experience to deliver speedy and efficient validation projects to our customers. The usual validation timeline is between three to six months; however, this is a collaborative effort between us and the customer. There are many different moving parts (lab IT, system owner, reviewers, approvers, etc.) and we need to get everybody on the same page with the level of attention and priority that each project requires. Thus, we can set up a service level agreement for five months and if they are on board and want to accelerate the process, we can expedite that to three months or less. Our customers are in good hands; we have the experience, processes and knowledge to ensure that their systems are being validated independently of the instrument supplier. Q: Many pharma companies have data quality issues due to outdated legacy systems that are difficult to maintain. Do you have any tips for transitioning to the latest technologies? A: This is a good question; it really depends on what we find during a data integrity assessment. Many customers have updated their data integrity policies to the most recent guidance from the FDA and they need to verify that their systems are compliant with those new policies and regulations. This verification is done through primary assessment. Firstly, we identify any gaps between the existing system and the current data integrity regulations. Then, we initiate remediation, that is, we make configurational changes, help with selecting and purchasing new equipment, then validate that new equipment. We can also assist with the necessary OS, firmware or software updates required to meet current industry standards. We’re currently seeing a trend of companies’ initiatives to assess and then remediate their data integrity gaps. The entire process can be contracted through PerkinElmer. It normally involves a mix of information and validation and compliance services teams. Both teams work together to assess and remediate IT and validation gaps. Q: What advice would you give to customers who are hesitant to share sensitive information or who are worried about data breach risks? A: This has a lot to do with building trust. We’ve been doing this for a long time and are happy to share references. We’ve performed services at many of the world’s largest major pharma companies. We have our finger on the pulse with regard to emerging best practices and we always apply the least burdensome approach. Thus, we can enhance compliance and streamline the workflows that customers have in their validation processes while building trust with our customers. We always sign a non-disclosure agreement (NDA) stating that we’re not sharing the data and delivering solutions according to their SDLC. Q: How does PerkinElmer ensure qualification protocols are customized according to customer requirements while minimizing cost and time? A: In general, our validation projects are defined by a three-phase approach: planning, execution and closeout. So, validation projects often are very complex; there are many stakeholders with a lot of moving pieces. The customer can provide a project manager but if that’s not available we will run the validation project with our validation leads. At the beginning of the implementation and planning phase, we gather the requirements. We review the testing done by the vendor and then trace out the configuration with the other qualification and the supplemental qualification needs. Finally, we trace that up in the traceability matrix. Our overall approach to validation streamlines the process and minimizes cost and time. Act now and fill in this form for expert guidance. 14 Pharmaceutical and life science laboratories face increasing demand for their services. Such demands include tighter deadlines, increased budget scrutiny, regulatory changes, pressure to improve reproducibility and considerations of rapidly evolving technologies. In this scenario, laboratory service providers - offering a complete suite of solutions - have become essential for labs looking to reduce the time invested in these duties and focus on core scientific activities. PerkinElmer OneSource offers a broad range of laboratory services including IT solutions (IT asset inventory, risk mitigation, standard platform deployment, change management supporting the GxP and research environments, etc.). Services are tailored to customers’ needs and cover the whole instrumentation life cycle. Moreover, IT lab services are integrated with validation and compliance services, enabling the delivery of comprehensive end-to-end solutions. In this interview, Larry Tibbetts, Global Product Manager for OneSource Information Services at PerkinElmer, discusses common IT challenges faced by pharmaceutical and life science industries. In addition, he reveals how PerkinElmer can help to overcome bottlenecks in a cost-efficient manner. Q: What are some shared challenges that users experience when updating their Windows operating system (OS)? How can these challenges be mitigated? A: Microsoft changed their OS model when they updated Windows 10 to Windows 11. Today, users get automatic updates from Microsoft and they only need to reboot their computers to get updates installed. However, a lot of laboratories still have Windows 7 and are presented with challenges when they need to upgrade their OS. One of the biggest problems is inaccuracy or the lack of inventories (the identity and location of instruments, computers and their OS, control software, etc.). Thus, a big pain point for many customers is the time cost required to remediate these inventories. Additionally, many customers don’t have the bandwidth and technical knowledge to manage the additional validation tasks related to an OS migration. To mitigate some of these pain points, it’s important to have robust inventory lists and to partner with a service provider who can manage your OS migration in a timely and efficient manner. Q: Customers may be hesitant to use a vendor’s update services due to cost concerns. How can customers evaluate the costs and benefits of using an outside vendor? A: Partnering with a provider that specializes in OS migrations can save time in executing the update. Expertise pays for itself. If you’re “reinventing the wheel” – which many customers do – the projects become lengthy, even within small pharmaceutical companies. However, our teams can provide a level of expertise that can remediate a site in days and not months through proven processes and procedures that are already in place. PerkinElmer has over 85 years of experience providing analytical testing solutions. Our customers highly value our expertise in both IT services and scientific aspects of the labs. By using PerkinElmer, companies can save time and money by not having to train their staff on these specific system aspects. We are a full-service provider and have the people and ability to quickly customize to a new environment. Discover the Potential of PerkinElmer OneSource Information Technology Services (IT) INTERVIEW 15 Q: Customers may be concerned that vendors will not be able to meet their service level agreements (SLAs). How does PerkinElmer address these concerns? A: PerkinElmer has proven industry best practices and procedures for the execution of lab IT services. For example, we have a robust ticket management process that involves daily meetings for a proactive approach. During the planning process, we apply our experience and schedule the work in such a way that there is a time buffer for unexpected findings to be fixed. SLAs are agreed upon as part of our service design, which is built based on the client’s environment. To date, our teams have exceeded a 95% SLA delivery benchmark across 13 different clients and 125 IT analysts. Q: What are the key benefits of having a comprehensive PC hardware inventory and software update system in place for a pharmaceutical company? A: Robust software and hardware inventories are a cornerstone of any pharmaceutical environment as they lead to a more streamlined lifecycle management process. This allows companies to proactively upgrade software and migrate hardware, reducing the number of break/fixes. An updated inventory is also critical for efficient troubleshooting, hence saving time and money. Inventories are also the foundation for any disaster recovery. In the event of a ransomware attack, having a complete inventory of instruments, hardware, software and their validation state is essential. For example, a few years ago a major pharmaceutical company got hit with a ransomware that wiped out their global research environments (over 12,000 computers). Within 15 seconds all their servers were gone. Fortunately, an individual had an inventory on their computer that was not signed on to the main network. That inventory saved the company and enabled us at PerkinElmer to help to accelerate the recovery from that disaster. Without that inventory, instead of months, it could have been years before recovering from the attack. Most likely, a ransom payment would have been required as it is practically impossible to perform a recovery without inventory. Because we work in collaboration with the compliance services team, we were also able to deliver the compliance documentation needed to return those systems to production use. Q: What makes PerkinElmer the best choice for service quality? A: PerkinElmer has been delivering lab IT services for over 13 years. Currently, we have over 125 IT analysts and subject matter experts (SMEs) globally. We’re nested in 13 global pharmaceutical companies spread over 4,050 sites. That brings an advantage in expertise – which is hard to match – over other service providers. Another benefit that sets us apart from competitors is our lab IT certification program that every employee goes through. There’s no technical school or college that teaches what is needed in our environment. Hence, PerkinElmer has the best experts delivering the most robust service. We also offer an appealing “per PC” pricing model, which differentiates us from the typical headcount model offered by other vendors. Why should a small company pay for a full headcount when it can pay for a percentage of a person and be supported by a regional hub or global support center? PerkinElmer’s model is a game changer in the industry. Companies can now manage their budgets more proactively as they are not investing in a managed service based on headcount. Instead, they can reduce costs and purchase a customizable solution based on their needs. Another advantage is that PerkinElmer OneSource offers end-to-end lab support solutions, not just a product. We offer instrumentation, lab IT, scientific services, validation services and compliance services. Our customers can pick individual packages, while other vendors don’t offer this flexibility or expertise. Take action today! Fill in this form for exclusive insights. 16 RESOURCES Discover how OneSource Instrument Qualification Services can guide your lab through automated, secure electronic or traditional paper qualification procedures with standard protocols customized to your specifications. Download this white paper to discover why data integrity is at the heart of laboratory compliance. Ensure all your lab instruments are maintained properly partnering with OneSource Multivendor Services. Explore OneSource education and training services. Choose the training that best suits your needs, from new user courses to customized advanced training by experienced scientists. Resources