Achieving lab compliance is essential to ensure product quality and safety. However, this is a challenging task that involves various elements such as software validation, data integrity, equipment qualification, etc.
As taking care of all these tasks can lead to decreased productivity, many companies turn to external providers to help them navigate evolving regulations.
By partnering with an experienced laboratory services provider, companies can streamline their compliance efforts, reducing administrative burdens and minimizing the risk of errors.
This eBook highlights customized end-to-end solutions to ensure compliance and maximize productivity.
Download this eBook to discover:
• How to optimize laboratory compliance
• The importance of data integrity and computer system validation
• How to integrate IT services with validation and compliance services
Laboratory Compliance and IT Services: eBook
Table of Contents
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
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.
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
Essential compliance requirements: a comprehensive
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
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
Validation refers to a documented process to establish that testing
methods, manufacturing processes and software are suitable for their
This is typically used to challenge the performance
of a new method/process/software before it is put into routine use in
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
installed (Installation Qualification, IQ), works as expected (Operational
Qualification, OQ) and is fit for the intended purpose (Performance
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
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
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
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.
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.
1. Laboratory compliance: Making the grade. Laboratory News. https://www.
grade. Published: 11 September 2008. Accessed: 25 May 2023.
2. Kanten C, Kanten D. Understanding GxP compliance in the lab. LabManager.
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
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.
Published: 8 December 2017. Accessed: 25 May 2023.
6. Porter DA. Qualification, validation, and verification. Pharmaceutical Technology.
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-
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/
SYSTEM LIFECYCLE SUPPORT
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.
• 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 Change control management
• 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 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
compliance specialists deployed
at customer sites
qualications executed CSV projects completed
Optimize your laboratory today.
Our knowledge and experience span multiple industries, so you will always get expert support, no matter your specialty:
FOOD ENVIRONMENT INDUSTRY
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.
INSTRUMENT FLEET MANAGEMENT PROFESSIONAL LAB SERVICES
& repair, inventory
and full life cycle
(MES). Empower &
(BCDR) planning, project managed
lab relocation and
support for areas such
as CSV, data integrity, technical writing and
services, general lab
support, lab efciency
• New instruments
• Instrument replacement
• New analytical methods
• Enhanced instrument or software capabilities
• Non-compliant systems
[Infographic] System lifecycle support: optimizing
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
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
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
• 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
• 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
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.
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 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.
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
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
[Infographic] Data integrity is at the heart of
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
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
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
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
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
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.
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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
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)
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
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
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.
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