ComplianceControl Centre

ComplianceControl Centre provides a simple, validated, system to control the document records associated with a modern business.

Polpharma, Poland

Polpharma is focused on production of Active Pharmaceutical Ingredients (API's) and development of branded generic pharmaceutical products.

Chemipharm

Chemipharm's modern GMP plant produces pharmaceutical products of all major forms (tablets, capsules, syrups & ointments). Ampoules, vials, eye drops; cephalosporin antibiotics are also provided.

ComplianceControl Centre

ComplianceControl Centre is an Electronic Document Management System (EDMS) and Electronic Quality Management System (EQMS). ComplianceControl Centre addresses the complex alignment of business, quality, compliance and validation procedures and processes provides a critical management challenge for all types of organisations.

Addressing these challenges cost effectively, ComplianceControl Centre not only provides significant business advantages in terms of both cost and enterprise-wide efficiencies, but also delivers the opportunity to implement common policies and procedures and ensure that standards are set, followed and maintained. With a single, secure database that is visible to key players across your organisation, guaranteed conformance, continued convergence and the use of correct terminology can be taken for granted. Certifying entire project life-cycle conformity becomes straightforward and non-compliance issues, audits and corrective actions are easily identified, tracked and managed.

Whilst it may seem strange to say that most modern businesses run on paper, in our increasingly regulated world this is not that far from the truth. It is now the case that many actions performed by an employee must be defined in a procedure; every employee who performs the action must show that they are trained in that procedure; every procedure must result in some objective evidence to indicate that the action has been performed.

The purpose of ComplianceControl Centre is to provide a simple, validated, system to control the document records associated with a modern business. ComplianceControl Centre is designed around a central database, used to record key information relating to the objects and records which are important to controlling a business. The information recorded in this database is presented in a structured manner which is designed to be set-up to reflect the physical and management structure of the business. Workers and Managers within the business are able to see records relating to only those activities for which they have a responsibility.

ComplianceControl Centre our Electronic Document Management System (EDMS) and Electronic Quality Management System (EQMS) provides a range of monitoring and reporting tools which will warn users where action is required by them, and also inform them of the status of those activities for which they have a responsibility.

Customer References
For a full list of customer reference please visit the Compliance Control website here.

Polpharma, Poland

Reference regarding David Forrest and Carl Turner from Compliance Control Ltd.

Polpharma

Polpharma is focused on production of Active Pharmaceutical Ingredients (API's) and development of branded generic pharmaceutical products. Polpharma is a leading Polish healthcare company. The strong branded products are franchised in cardiovascular, gastrointestinal, CNS/pain and consumer medicines.

Polpharma is the biggest APls producer in Poland. Its synthesis plant consists of salicylic acid and derivatives, sulphonamides, psychotropics and custom syntheses. Polpharma is a qualified supplier of APls for many worldwide pharmaceutical companies. Everything the company does is based on its experience in the industry since 1935. Particular care at every stage of production guarantees the highest quality. The modem technologies in use at Polpharma's facilities target compliance with GAMP4 and GLP requirements, and its pharmaceutical production is approved by audits of the US FDA. Having achieved a strong position in Poland, Europe and North America. Polpharma has a strong platform for future development.

Polpharma required a system to manage their global business and be adaptable enough to be able to add acquired pharmaceutical businesses to their organization when necessary, the system had la be able to operate in multiple languages and multiple currencies as well as giving the senior management the ability to be able to view and report globally, the system also needed to be easily upgraded with new functionality when required. The chosen solution had also to be compliant with all the current regulatory requirements for the Pharmaceutical industry.

In order to meet the business requirements, Polpharma have been implementing Oracle E• Business Applications in a phased approach since the end of 2002, with Financials and Logistics modules going live in August 2003.

The modules included in the implementation are:
• Oracle Financials
• Oracle Order Management
• Oracle Purchasing
• Oracle Inventory
• Warehouse Management System
• Oracle Process Manufacture Suite
• Advance Planning & Scheduling and Demand Planner

Compliance Control have been instrumental in the success of Oracle in Polpharma, ensuring a GAMP compliant and validated system.

When we started our Oracle Applications project tor Polpharma in Poland, Compliance Control were recommended to us by Oracle. Since Compliance Control started with us, they have enabled us to understand how we can ensure that our Oracle Implementation can be compliant and validated. David, CarI and his team work seamlessly with Polpharma and Oracle implementation team in helping to ensure that as the project progresses all the GAMP 4 requirements are met.

This started with the creation, review and approval of a Validation Master Plan, that acted as the driving force behind the project and the deliverables. The fact that they are involved in the GAMP Forum and on many of the GAMP Special Interest Groups, ensures that we are kept up-to-date and informed of global issues in the industry so that we can ensure that our system complies with the latest understanding.

Carl and his team worked in parallel with oracle and percipient implementation consultants. to ensure that all the key GMP issues, documents and deliverables were in place when needed, Assessments and reviews of the GMP critical functions were carried out, and also complete documentation to ensure that all the 21 CFR Part 11 functions were implemented correctly. Carl acted on behalf of our Quality Assurance department and reported directly to the steering committee. In this way we knew immediately if there were any Quality Assurance issues. Carl and his team ensured that all the documentation was controlled and up-to-date and in particular ensured that once a deliverable was approved and frozen, that change control was used thereafter.

Two key areas were in the Design/Specification stage, and the Testing phase. It was important that all documentation was reviewed and in particular that the Functional/Configuration specifications were sufficiently detailed in the GMP areas to ensure that the test specifications and protocols required for the IQ,OQ and PQ were also detailed enough. Compliance Control also ensured that all the testing process was carried out in an organized and professional manner so that all the test results were collated, reviewed, and signed off to ensure that the final validation report was approved.

I believe that not only did Compliance Control ensure that the project was compliant and validated but that it also ensured that the project was on time, by following the strict deliverables and time line in the Validation Plan. The result was a Compliant and Validated system that has now been inspected by regulatory authorities including the FDA which passed with no major issues. I would not attempt to carry out a similar complex system implementation in such a GxP critical situation without the help of such industry experts. Not only will Compliance Control ensure your project is Compliant and Validated, but that they will do it in a cost effective way.

A further by-product of their help was the 'knowledge transfer' by providing formal training courses to our internal staff, and 'on the job' training so that we are now in a position to support and maintain the validated status of the system using our internal resources.

I can certainly recommend Compliance Control as experts in this field and they will add value and deliver on your project.

Thank you, Wlodek Gryglewicz, Polpharma CFO

Chemipharm

Chemipharm appoints Compliance Control Ltd. to help with their Computer Systems Validation Strategy November 2011

Chemipharm

Chemipharm was founded in 1972 by Dr. Gamal Kamel as the first private sector importer of pharmaceutical products in Egypt. Over the last 35 years, Chemipharm has developed and maintained an invaluable reputation as Egypt's most respectable and high standards pharmaceutical distributor.

In 2003, based on our continuous growth, Chemipharm has established its own manufacturing facility in the 6th of October Industrial Zone. The modern GMP plant produces pharmaceutical products of all major forms (tablets, capsules, syrups and ointments). In August 2011 Chemipharm extended its facilities by adding a new sterile area to produce ampoules, vials and eye drops; and a new cephalosporin facility to produce both oral and sterile forms of cephalosporin antibiotics.

The company's strategy is based on continuous improvement and growth.

With the above strategy in mind Chemipharm appointed Compliance Control Ltd. to help with their Computer Systems Validation Strategy. In particular the brief was to ensure that all Computer Systems, ranging from ERP to Equipment conformed to the latest regulatory standards. A high level Validation Master Plan has been created along with a Computer Systems Validation Policy and Procedures. Several intensive training courses have been carried out and a range of Retrospective and Prospective Validation activities are in progress.

Compliance Control Ltd. will also configure their online Integrated Electronic Quality and Document Management System: ComplianceControl Centre, which will help to manage and control all quality activities. Chemipharm will also be using Oracles’ User Productivity Kit, which will help with the preparation of their Validation documentation and Training material.

Michael Atallah, Business Development Manager, Chemipharm Industries stated: “We were looking for a company with a track record in Computer Systems Validation and also with experience of working in Egypt, EU and the USA. Compliance Control Ltd. has provided 3 consultants over the past 6 months to help us with our strategy. They have brought immediate expertise to our team and are in the process of knowledge transfer. As part of our drive into the European market we wanted an organization with proven experience ensuring our organization can meet EU regulatory requirements”

David Forrest, Chief Executive of Compliance Control Ltd. stated: "It is a real pleasure working with Michael and his colleagues at Chemipharm. It is pleasing that our experience has been acknowledged by Chemipharm by the award of this project. Chemipharm have a lot of experience in Equipment Validation, but we bring the additional Software Validation skills to complement their team. The use of ComplianceControl Centre will really help them to have control and visibility over all their Quality Key Performance Indicators".

For further information on Chemipharm, refer to: www.chemipharm.com

Project
Management

Our experienced Project Managers can plan, organize, motivate and control your resources to achieve your specific goal(s).

Quality
Management

For more than 15 years Document IT & its partners have been at the forefront of computerized system validation & IT system compliance.

Quality Management

Business
Consulting

Our consultants work with clients to model & improve business processes, streamline operations & assure compliance.

Business Consulting

Resourcing
Services

Our resourcing services are open to any industry looking for a highly skilled worker.

Outsourcing

We currently offer full business process outsourcing within our CDISC Factory for clinical business processes around the usage of standardized clinical data.

Outsourcing

Bio Statistics

Our expertise includes the design & conduct of clinical experiments, the method & way in which data is collected, analysis of data & interpretation of results.

Clinical
Programming

We offer you comprehensive range of high-quality & cost-effective clinical programming services.

Clinical Programming

Clinical Data
Management

We provide end to end clinical data management solutions from data management plan to database lock.

Clinical Data Management

CDISC
Factory

Document IT’s CDISC factory supports & accelerates the set-up of CDISC compliant systems & conversions of legacy clinical trial data to the CDISC standards.

Records
Management

Document IT maintains the records & documents throughout their life cycle from the time they are created until their disposal.

Records Management
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