pqe brochure ph_english_june_2016

Your Complete Quality Solution Provider for the Life Science Industry

We are a ISO 9001 certified technology solutions and compliance

consulting services company with global capabilities deliverable

throughout the entire product quality life cycle, allowing us to

offer services at a very competitive price.

PQE at-a-glance WHO IS PQE?• Quality and Compliance Solutions Provider – Complete Quality Solution Provider for our Customer’s GCP, GLP, GMP & GDP product

development challenges since 1998.

• Hundreds of compliance solutions consultants on staff, enabling rapid global deployment of flexible, well-organized project teams anywhere

our clients require

• Wide geographical coverage - offices throughout Europe and North and South America, the Middle East,

India and China.

• International references thousands projects completed worldwide.

• Experts fluent in more than 20 languages.

• Experience in working on regional/global projects and rollouts for large corporations.

• Long history of supporting local leaders and small/medium companies in reaching

FDA / EMA / ANVISA / WHO and other international, regional and local regulatory

compliance authorities .

• Proven methodology along with effective knowledge transfer mechanisms.

• Exceptional focus on cost effectiveness, while maintaining the highest quality standards.

• Internal instruments warehouse with “project ready” equipment validation & utilities

qualification instrumentation with traceable calibration certificates.

WHY PQE?Our broad services portfolio, extensive experience,

effective project management, and exceptional cost effec-

tiveness, have already proven to be a winning combination

for global corporations, as well as small and medium sized

companies.

PQE / CORE BUSINESS

Since the foundation of PQE, I have strongly believed that our core values, know-how, people and ethics, can make PQE the market leader

for sustainable compliance solutions in Europe and beyond. As a matter of fact, we are growing year by year thanks to a full time workforce

of dedicated employees, which allows us to enhance our robust and standardized commitment to excellence. Our passion for the growth and

development of life science companies enables PQE to consistently exceed our customer’s expectations. This is the reason why we have suc-

cessfully completed thousands of projects around the world, working in more than 20 different languages. Come discover what our customers

have experienced.

PQE: Your Partners in Excellence

Gilda D’Incerti, CEO

Data Integrity AssuranceGlobal leader in full product life cycle computer system validation and IT compliance.

Qualification & Engineering Your reliable partner for GMP Review, Facility Design, Qualificationand Commissioning Activities.

Regulatory AffairsA full service provider supporting companies through the entire regulatory lifecycle

ComplianceLeading global services for cGxP compliance needs.

Data Integrity Data integrity may expose life science companies to significant regulatory and business risk. PQE’s multidisciplinary teams allow customers to achieve compliance and the Data Governance System, which is integral to a fully functional Quality System. The integrity of regulated data relies upon the validation of the computer system responsible for managing regulated data. As a proven global leader on this topic, PQE can support customers in the implementation of a cost effective and feasible validation strategy. This results in the assurance of the systems validation life cycle, which in turn enhances and improves product quality, patient safety and data integrity. PQE’s integrated approach enables client’s data integrity assurance and validation requirements through a scalable and fully regulatory compliant delivery model, based on a robust risk analysis.

DATA INTEGRITY ASSURANCE

• Data Integrity Policy• Computer Validation Strategy • Best Practices for Cost Saving & Quality of

21 CFR Part 11 compliance strategy• Validation Templates and System-specific

Packages

• 21 CFR Part 11 & EU GMP Annex 11 As-sessments

• Risk-prioritized & Turnkey Remediation projects

• 21 CFR Part 11 Inspection Readiness pro-jects

• Data Integrity Historical Verification• Continuous Monitoring procedures for

Data Integrity• Audit Trail Review Methodologies

Capabilities:


Computer System Validation

Computer System Validation has been PQE’s core business since its foundation in 1998. We have an unmatched track record of providing our clients with strategy and execution support with their FDA / EMA / WHO / TGA / SSA/ SFDA /ANVISA / INVIMA and other Local Regula-tory Body compliance projects. Our multidisciplinary team, which has extensive years of expe-rience, enables us to support our clients in turnkey validation projects for all types of compu-terized systems: management information systems, systems from a manufacturing area and applications used in Laboratories.

• Ongoing Adaptation of Risk based Compu-ter Validation Approach to current Regula-tory expectations

• Computer Validation of Global and Local IT Systems (e.g. ERP, LIMS, MES)

• Laboratory Systems Validation• Process Control Systems Validation• CSV Best Practices

• Documentation Templates• User Requirements and Process Mapping• Data Migration Verification strategy and

execution• System Testing (Unit & Integration Tests,

UAT)• Validation Test Planning, Execution &

Documentation

• Best Practices Procedures to maintain the Validated status• Change Management• Periodic Reviews

Capabilities:

Regulated IT Solutions

Regulated IT Solutions consists of a multidisciplinary team of professionals with a background in electronic engineering, software development, systems integration and information techno-logy. We are able to offer a broad spectrum of scalable services, thanks to our proven expe-rience in the field of IT solutions, infrastructure qualification and computer systems validation for life science companies.

• Assessment of the compliance level of IT processes against international standards and guidelines (eg. GAMP, NIST, ITIL)

• IT Infrastructure Qualification• IT Infrastructure design & implementation

project management• Design and implementation of secure

WANs

• Selection and evaluation of hardware and software suppliers

• Management and monitoring of system integrator

• Design & management of server rooms and networks

• Data housing and hosting services • Data archiving and retrieval • ERP suitability and gap analysis • Security standard assessment

Capabilities:


Qualification & Commissioning

Our service excellence is achieved through an interdisciplinary teamwork among engineers and technicians, who have a unique integrated knowledge in process engineering, information technology and quality in regulated environments.Due to our complete in house instruments park and our robust expertise in Pharmaceutical, Biopharmaceutical and APIs field, we can provide turnkey qualification solutions for process equipment and utilities qualification, based on the latest technologies and regulatory require-ments. This allows us to focus on minimizing compliance related risks and costs for our clients.

• Qualification protocols writing and execution (Installation, Operational and Performance Qualification)

• Validation Master Plan• Commissioning Plan• Cleaning Validation• Process Validation

• Media Fill Protocols• Calibration services• Witnessing of Supplier Testing activities

(FAT/SAT support)• Inventory of Process Equipment and Utilities• Quality Risk Management

• User Requirement Specifications• Technology Transfer • Process Analytical Technology

(PAT) Support• Clean Room Qualification• Temperature Mapping Services

Capabilities:

QUALIFICATION & ENGINEERING

Facility Engineering There are many steps in the design of a pharmaceutical facility. In PQE’s approach and solu-tions, we emphasize delivery based on our three key project principles: TIME - COST - QUA-LITY.Our goal is to establish a partnership with our clients in order to create cost- and business- effective engineering solutions for Pharmaceutical, Biopharmaceutical, APIs and Medical De-vices facilities and to ensure that related national and international regulatory requirements are met.Due to our focus on Life Science, we always assess and design with the latest standards and with the point of view of the facilities end users.

• Concept Development • Basic & Detail Design • Technology Transfer Support • Commissioning Support• GMP Review

• Construction Supervision• Project Management • Visual Factory Programs • Procurement Support


Capabilities:

Regulated Laboratory Solutions

PQE has multidisciplinary and specialized teams, which include engineers, chemists, biolo-gists and IT experts. Our aim is to support laboratories in the food and drugs industries, with independent and fully specialized services providing accurate and reliable analytical data in a fully regulated environment.

• Data integrity and compliance• Purchasing and project coordination for new

laboratories and renovation• Process mapping and solutions for a paperless

lab• Analytical instrument qualification

• Equipment calibration and maintenance plan• Analytical computer system validation• LIMS, Chromatography Data Software vendor

selection, support and validation• Analytical method development and validation• Stability studies

Capabilities:


COMPLIANCE

GMP & GDP Compliance We want to be sure that we understand your needs, in order to support, protect and help you thrive in all markets. Our aim is to help you be stronger and fitter. Our customized and cost-effective solutions for Quality (beyond compliance) are a competitive advantage; as non-com-pliance is an expense that no company can afford. PQE’s commitment is to help our customers identify problems with a proactive attitude, before they arise; this commitment will guide you to make your processes smarter and more efficient. Overall we will support you to find the most sustainable way to develop practical and tailored plans that align global quality capabilities with your business strategy.

Capabilities:• Compliance Strategies• Continuous improvement and performance

metrics implementation• Risk Management implementation• Quality system implementation (corporate

policies and local SOPs)• Quality structures (QC, QA, RA) assess-

ments for skills and staffing• Inspection readiness Master Plans (FDA,

EU, ANVISA, CFDA, PMDA, TGA etc)

• Mock Inspections• Assistance during inspections/post-inspec-

tion• Due diligence (Quality) of product and faci-

lity acquisitions• Third party auditing• Supplier management and monitoring stra-

tegies• Training systems implementation

• Training in GMP/GDP compliance and to-pical matters

• Mentoring/coaching• Support in critical event management

(complaints, deviations, sterility/mediafill failures, recalls)

• Change management support• CAPA System Implementation• Annual Product Review support• Data Trending

GCP Compliance The development of a GCP Quality Management System (plan and resources) is the basis to promote and support compliance, while minimizing regulatory risk. PQE proposes the imple-mentation of a GCP quality strategy that will adapt to the Client’s requirements and support an effective and compliant conduction of clinical trials. This monitoring process ensures adequate protection of subjects, along with the quality and integrity of the clinical study data itself. In order to deliver leading GCP services to PQE clients, our consultants practice the most inno-vative Quality by Design and Quality Risk Management approaches related to clinical studies. PQE ensures a strong emphasis on the concepts of good quality control, with adequate do-cumentation throughout the delivery of a clinical trial by investigators and throughout all data management processes leading to a regulatory submission.

Capabilities:• Self-assessment of GCP Quality System

compliance against written standards (pro-cess mapping and gap analysis)

• SOPs/Policies Development and admini-stration

• Audits: - CROs - eSystem providers - Centralized service providers (e.g. labo-

ratories, cardiac safety) - Clinical database - Study Documents - Trial Master File

• Site assessment (feasibility, compliance)• Inspection readiness (Sponsor, CRO,

investigational site)• Inspection support (back and war room)• QA services and training

COMPLIANCE

PV Compliance In 2010, Regulatory Authorities raised the bar of compliance of the Pharmacovigilance System and an increasing number of countries are now performing routine regulatory inspections targeting Pharmacovigilance. An established quality system that is adequate and effective for performing pharmacovigilance activities has become a regulatory requirement. PQE can support the implementation of a pharmacovigilance quality system, starting from the compliance assessment of “AS-IS” scenario, which involves document editing and the quality system deployment at corporate or local level. The focus of PQE’s support is the compliance with applicable regulation as well as the suitability of the system to the company needs.

Capabilities:• Self-assessment of Pharmacovigilance

System compliance• Editing of quality documents (Policies/

SOPs/Working Instructions)• PSMF editing• Cleaning of safety database

• SOPs review and deployment• Compliance monitoring• Preparation for Regulatory Inspection• Post inspection Follow-up• CAPA definition and implementation• Development of Training Plan

• Pharmacovigilance Audits• Qualification of PV service providers• Data Migration Plan and Data Quality Control

COMPLIANCE

Third Party Audits• Manufacturers of API, Intermediates and

Excipients (APIC certified Auditors)• Distributors of API• Contract Laboratories (GMP/GLP)• Manufacturers of Final Drug Forms• Distributors and Logistic Providers (GDP)• Software Suppliers (PDA and Tick-it certi-

fied Auditors)

• Contract Manufacturing Organisation• Laboratory Testing• Clinical & Pre-Clinic Audits• Investigational Site Audit• Sterilisation Facilities• Storage and Distribution• Suppliers of Equipment & Utilities

Based on recent developments in pharmaceu-tical regulations, concerning starting materi-als and suppliers, qualification has become even more critical from the GxP perspective. Furthermore, EU and FDA regulators have emphasized that Third Party Audits are ac-cepted. By utilizing its experience in the Life Science sector, PQE supports manufacturers in performing many kinds of audits, conduc-ted worldwide by our lead auditors that have a minimum of 15 years of field experience.

Capabilities: Learning Management and Knowledge Transfer • Computer System Validation (GAMP,

21CFR Part 11, IT infrastructure)• FDA Inspection Readiness• Quality Management System• Process Equipment Qualification • Laboratory Equipment Qualification• Process Validation

• Analytical Methods Validation• Regulatory Affairs• Risk Management• GCP Compliance and Clinical Trials• Process Analytical Technology• Technology Transfer• Pharmacovigilance

PQE offers cost effective practical training courses based on latest industry guidance, regulations and real life experience. All cour-ses are full of examples, case studies, and are held by our top class executive consul-tants.Courses can be organized both at funda-mental and advanced levels based on the fol-lowing topics:

Capabilities:

COMPLIANCE

REGULATORY AFFAIRS

Regulatory Affairs PQE supports customers through the entire drug regulatory lifecycle, providing a full range of regulatory activities. Our service begins with the development of the regulatory strategy and concludes with the editing, amendment and submission of the necessary documents of the dossier.Due to the expertise of our consultants, fully electronic submissions for the EU / USA, along with paper submissions are handled in the fastest and most professional manner, while ensuring that dossiers are compliant to the strictest regulations.

Capabilities:• Regulatory Strategy for EU, USA, LATIN

AMERICA, CANADA and other countries• Dossier gap analysis and review for Drug

Products and Drug Substances• DMF / ASMF / CEP Dossiers preparation

in eCTD or NeeS format

• Preparation of Product Registration Dossiers (Quality part)• Country-specific Module 1• Expert Reports, Overviews and Summaries• Investigational Medicinal Product Dossiers

• Variation/Change application Dossiers• Reformatting of documents to eCTD

compliant submissions• Drug Listing• Support for electronic submission

pqe brochure ph_english_june_2016

Healthcare