GMP requirements for computer systems: Verification and revalidation After a suitable period of running a new system Independently reviewed and compared with the system specification and functional specification Change control Alterations made in accordance with a defined procedure Provision for checking, approving and implementing the change Checks Data checked periodically Confirm accurate and reliable transfer 12 Security Production as well as in quality control Data entered or amended - authorized persons Password system Security systems to prevent unauthorized entry or manipulation of data SOPs for entering data, changing or amending incorrect entries and creating back-ups 13 Back-ups Procedure describing steps to be taken for the continued recording and control of the raw data in the event of a computer system interruption or failure.

Regular back-ups of all files and data Secure storage (prevent intentional or accidental damage) 14 Validation of hardware Appropriate tests and challenges to the hardware No influence of static, dust, power-feed voltage fluctuations and electromagnetic interference.

successfully validating erp systems-19

It facilitates the flow of information among the different functions within an enterprise. A provider of specialty respiratory, cough/cold, pediatric and central nervous system products and maintains a manufacturing facility in Decatur, USA Pharmavision has been implemented to the company's core business process and key manufacturing areas.

It is a “do it all” system that performs everything from entry of sales orders to customer service. Med Pointe's financials, order management, procurement, inventory management, batch management, process manufacturing, quality management, distribution, custom interfaces and charge back processes effectively employed the solution in only six months 37 QUESTIONS What are ERP systems?

But not every company gets the return from using the ERP system.

I have been part of 3 different ERP systems and in my experience companies are failing to set up the ERP system because they cannot reach the predetermined goal.

20 EARLY HISTORY OF BUSINESS COMPUTING 1960s - Focus on inventory management and control in production environments 1970s – MRP (Materials Requirement Planning ) software debuts to assist in production scheduling and inventory management -Focuses on resources needed to accomplish scheduled production and when they are needed 1980s – MRP II (Manufacturing Requirement Planning) expands focus of previous systems into management of entire production process incorporating non-production data such as from marketing and finance 22 CONT … Explain the advantages of implementation of ERP systems.

1990s - ERP (Enterprise Resource Planning ) systems apply same data collection and handling mechanisms organization-wide - Expansion of MRP II concepts to all business functions ERP Software Market Revenues, 1993 - 1999 23 ADVANTAGES facilitates information sharing across organizational units and geographical locations Improved work process Increase access to available data for decision making Timely and accurate information Quick response to changing business operations and market conditions, resulting in improved competition advantages Reduced paper use 24 DISADVANTAGES Cost - very costly - beneficial for large companies only Long implementation process ( 2 – 5 years ) Missing functionality for handling earned value, percentage complete and cost forecasts in determining project progress No integration between an ERP system and non-ERP systems Security issues 25 WHAT IS SAP ??? (June/July- 2011) Describe the salient features of SAP with reference to pharmaceutical industry.

generate batch documentation, different batches of material used in a batch listed) Worst case : Validation under different conditions (e.g.

speed, data volume, frequency) Repeats : Sufficient number of times (e.g.

This blog review of Enterprise Resource Planning or ERP Implementation procedures and critical success factors.