G x P S y s t e m s

T h e R e g u l a t o r y C o m p l i a n c e

E x p e r t s

With a proven track record on global

compliance projects, our people

help companies keep their

systems in a state of

validated compliance

without losing

operational flexibility

and productivity.

Our Advantages Work for You • Fixed scope projects, on time and within budget

As we provide fixed scope/cost projects, you never have to worry about going over budget or missing your deadlines

• Continuous knowledge transfer Your success is our success, so we make sure that your team has the knowledge they need to keep your systems in regulated compliance

• Effective culture change Not only do we help you achieve regulatory compliance, we ensure your teams understand and appreciate the significance of their daily approach to quality

• Top level personalized attention Our management team has a wealth of experience in the life science industry so we can provide the highest level of attention and service to you

• Project follow up When we have completed your project, we are available to discuss and address any additional concerns you may have

GxP Systems provides world-class validation and compliance services to multinational clients in regulated life science industries. Leading businesses in the biotech, medical device and pharmaceutical industries choose GxP Systems to achieve regulatory compliance.

We have earned a reputation for excellence and reliability by maintaining a team of the top engineering and project management experts

in the life science industry. This expertise enables us to create strategic solutions and deliver results in compliance and

competitiveness.

Established in 1997, GxP Systems has European headquarters in Cork, Ireland and U.S. headquar-

ters in Cambridge, MA, with a number of regional offices.

. 1

AUDITINGOur team will make your team audit-ready. With an impending audit, you can rest assured that GxP Systems will deliver expert auditing services. Specializing in multi-site and global supplier audits, we have auditing experts who can help you with all of your auditing needs:

• Multi-site audit programs

• Periodic review to assess and report on the performance and validated state of all your systems and equipment

• Risk assessment using a wide range of techniques including FMEA and PFMEA to identify and quantify the appropriate level of validation

• Software quality assurance/practices to report on processes and methods used by all key software project stakeholders

• NDA, 510(k) and CMC compliance ensures all your new and existing products comply with all applicable regulations

• FDA remediation programs address 483s, warning letters and consent decrees by auditing your programs and strategies, followed by implementation and execution of required activities

• 21 CFR Part 11 & Annex 11 compliance that creates, maintains and supports controls to ensure data authenticity and integrity

• Global supplier audit programs to evaluate compliance of your suppliers against FDA standards

• Contract Manufacturing Organization (CMO) audit makes sure your outsourced manufacturers’ procedures are consistent with regulatory requirements

• Pre-UAT, pre-go live readiness audit and post go-live audit services ensures your readiness to begin an operation

• Internal quality auditing provides unbiased and independent report, highlighting all relevant issues

• Policy and procedure review against all current GMPs ensures compliance with all relevant regulatory standards

• GMP, GLP, GCP program auditing

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2 . a u d i t i n g

REMEDIATIONIf you’ve received a warning letter or consent decree, it’s a relief to know that expert help is just a phone call away. With in-depth knowledge of regulatory guidelines and our superior ability to return systems to a state of validated compliance, we excel at remediation services.

We offer a complete range of remediation services, focusing on improving your operations and enabling you to stay compliant in an ever-changing and challenging regulatory environment. From initial gap analysis and remediation planning for existing systems to prospective assessments of new systems, our experienced teams will help determine the regulatory relevance and requirements for compliance.

If you’re in need of remediation, you will benefit from our proven approach to remediation:

Comprehensive Objectives and Priority Definition• Determination of nature of work

• Preliminary meetings to address your compliance concerns

• Review of specific audit findings

• Scope identification and high-level plan development

Accurate Gap Assessment• Determination of any underlying issues

• Analysis of internal or external audit findings, customer complaints or adverse operational events

• Clarification of core problems and shortcomings

• Gap assessment report

Effective Formal Plans• Gathering information from your team

• Formal project plan that identifies timeframes, team requirements, project roles and responsibilities

• Agreement between all principal stakeholders

• Complete project visibility

Successful Project Execution • Supervision and inspection by our senior management team through internal

reporting and on-going quality review of all completed work

Project Follow-Up• On-going consulting and advisory services

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VALIDATIONGxP Systems has a successful track record of introducing a right-sized validation approach to our life science customers. Whether it is introducing a new product, transferring a line, or bringing an existing line into a state of validation, our expert validation teams will provide you with up-to-date policies and procedures.

You will benefit from our right-sized validation approach:

Accurate Scope Determination• Inventory list preparation

• Inventory classification based on risk assessment

• Assessment of policies and procedures

• GAP assessment

Customized Validation Activities• Identification of key customer staff

• Project plan

• Project execution

• Remedial development of policies and procedures

• Remedial design of validation templates

• On-going monitoring of project performance

• Knowledge transfer during and after entire project life cycle

• Project close out and handover

• Optional post-project services

Validation Services Our extensive range of validation services will meet your unique needs:

EQUIPMENT VALIDATIONThrough our equipment validation services, we document the verification and qualification of all equipment as it is used in your manufacturing environment and ensure that the validation status of the equipment is maintained throughout the lifecycle of the validated system. Typically, our equipment validation projects incorporate the following deliverables:

• Validation policies and procedures

• Validation master plan and project plans

• User and functional requirements/specifications

• Risk assessment procedures and methods

• Development of design and test case qualification protocols including traceability matrices if required

• Test protocol execution and summary reports

• Deviation and change control management

• Periodic review and validation monitoring

• Roll-out of knowledge transfer program

4 . v a l i d a t i o n

COMPUTER SYSTEMS VALIDATIONOur computer systems validation services document the verification and qualification of all software and software-controlled systems as they are used in your operational environment. Through our services, we ensure that the validation status of these software elements is maintained throughout the lifecycle for the validated system. Typically, our systems validation projects incorporate the following deliverables:

• Validation master plan and project plans

• Validation policies and procedures

• User and functional requirements/specifications

• Risk assessment procedures and methods

• Development of design and test case qualification protocols and traceability matrices

• System code review and unit acceptance testing

• Integration testing and performance qualification

• Test protocol execution and summary reports

• Deviation and change control management

• Periodic review and validation monitoring

• Roll-out of knowledge transfer program

FACILITIES VALIDATIONWith a team of highly skilled engineers, possessing vast experience across electrical, construction and environmental engineering disciplines, GxP Systems has a multi- disciplinary approach to facilities validation services. Using this approach, we prove and document that equipment or ancillary systems are properly installed, function as designed, and lead to the expected results. This process will establish and provide documentary evidence that your premises, supporting utilities, equipment, and processes have been designed, installed and operate in accordance with the requirements of cGMP.

PROCESS VALIDATIONGxP Systems performs validation of new processes, equivalent processes, process improvements and process changes to be introduced into your manufacturing area—all while meeting the domestic and international regulatory compliance requirements for process validation. Each process validation will vary in its scope, based on the reason for the validation, criticality and complexity of the process and associated equipment.

SUPPLY CHAIN VALIDATIONWith the increased emphasis on supply chain quality, companies are finding it a challenge to ensure their supply chain is compliant with all regulations. We will execute through the supply chain validation process, including auditing, verifying, validating and monitoring, to ensure your suppliers’ processes and systems meet domestic and international regulatory compliance requirements by overcoming supply chain challenges such as:

• Adverse standards of compliance by suppliers

• Poor monitoring of supply chain quality

• Wrong-sized incoming quality inspection processes

POLICY AND PROCEDURE DEVELOPMENTOur team of experienced life sciences consultants will help you with the development and design of compliance policies, processes, procedures and subsequent supporting documentation to suit your operational and regulatory needs.

v a l i d a t i o n . 5

COMPLIANCEGlobal businesses in regulated industries, like yours, turn to GxP Systems to achieve compliance within an increasingly complex regulatory environment. With a proven track record on global compliance projects, our people help companies keep their systems in a state of validated compliance without losing operational flexibility and productivity. In fact, GxP Systems teams are regularly recognized by our customers as having delivered on time, within budget and with energy and commitment.

Our successes from continuing audits by worldwide regulatory bodies are a testament to the quality and relevance of our approach for compliance for every client. Our compliance services meet your specific needs due to our unique approach:

Comprehensive Risk Assessment/Analysis• PFMEAs, Root cause analysis

• Risk index calculations

• Functional risk assessment

• Site-applicable risk assessment

Holistic Project Approach• Based on global industry regulations such as FDA, EMA, IMB

• Full gap analysis

• Protocols, work instructions, and standard operating procedures development

• Effective knowledge transfer

• On-going managed services

Proven Project Life Cycle Expertise• Extensive library and repository of industry-related documents, processes and

guidelines

• Long history of experience in the life sciences sector

• Basis for continuous compliance throughout project phase(s) and beyond

• Expectation of successful future audits and compliance inspections

6 . c o m p l i a n c e

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QUALITYGxP Systems highly experienced team of quality experts develops, rolls out and maintains the Quality Management Systems required for the organizational structures, procedures, processes and resources to implement quality management at your manufacturing sites.

Quality Engineering GxP Systems provides an in-depth knowledge of a wide range of quality support systems to support on-going process improvement.

Quality Management Systems (QMS) With extensive experience in developing and supporting quality management systems (QMS), GxP Systems can help you with:

• Change control

• Periodic review

• CAPAs

• Auditing

• SOPs

• Document control

• Deviations

• Validation

Our approach through an integrated set of processes, such as QSIP, delivers a compliant quality program as well as introducing various quality improvement initiatives (Quality Improvement Plan).

q u a l i t y . 7

8 . t e c h n o l o g y t r a n s f e r

TECHNOLOGY TRANSFERIf your company has a need to ensure a smooth transfer of technology or equipment, GxP Systems efficiently transfers and validates skills, knowledge and technologies among life science manufacturing sites to ensure the delivery of compliant processes. We leverage our high level of expertise to analyze existing and new sites to enable a smooth technology transfer from site to site.

To ensure that transfer of equipment, line or train of equipment will consistently produce a result that meets pre-determined acceptance criteria, our Technology Transfer services include:

Production Line/Equipment Moves/Transfers• Location-to-location, either internally or externally

• As-is assessments

• Decommissioning activities

• Target location/process requirements

• Risk-based and right-sized qualification and requalification activities

Our successes from continuing audits by

worldwide regulatory bodies are

a testament to the quality and

relevance of our approach for

compliance for every client.

© 2013, GxP Systems. 11/13

www.gxpsystems.com

Europe

The Atrium Blackpool Cork Ireland

P +353 21 4215 050

E  info@gxpsystems.com

United States

Cambridge Innovation Center One Broadway, 14th Floor Kendall Square Cambridge, MA 02142  USA 

P +1 617 401 2128

E  info@gxpsystems.com