Introduction

Welcome to Factorytalk’s 1st edition of “Call in for a Coffee”. A significant amount of unnecessary time and effort is being spent on Computer Systems Validation (CSV) in the pharmaceutical industry. This edition points out where the problems lie, and summarizes practical steps for significant improvements.

When too much is too much! CSV Overdone...

Computer Systems Validation (CSV) rules & regulations have been shaped by industry regulatory bodies, such as the US FDA, in an evolutionary fashion.

One good example is CFR 21 Part 11 which identifies the requirements for electronic record keeping and electronic signatures.The response to the regulations, however, has been open to interpretation. The result is a significant amount of unnecessary time and effort being spent on CSV projects, without realizing the return on investment. That is, the quality of validated systems is not necessarily higher than the quality of non-validated systems. Estimates of project costs with CSV are 20-50% over comparable projects without CSV; with much of this effort being spent on non-value-added activities, such as obtaining numerous approvals, over-documenting, and over-testing.

The major issue is the vague nature of some regulations. People in various companies and various departments interpret the regulations differently. This leads to inconsistent policies and procedures often within the same company, causing greater confusion and further discussions around which is the ‘right’ or the ‘best’ interpretation.

Improving CSV

We have identified four major elements to manage the CSV approach, reduce costs, and raise the quality of systems subject to CSV. These steps address strategy, process, technology and people components.

Step 1: Start with the right strategy

■ Generate company-wide CSV policies - document the company’s position on specific CSV strategies, such as custom versus packaged systems, retrospective, change control, re-validation. Make sure all departments are aware of them and can refer to the company’s point of view, rather than generate their own.

■ Provide risk analysis guidelines - identify methods to be used for analyzing risks, including GMP compliance and business function risks. Define high, medium and low risk systems.

■ Create an outsourcing strategy - determine which, if any, CSV consultants will be used. Identify preferred software vendors, or determine standard criteria for application / vendor selection. Work with vendors to define practices for development and maintenance of systems.

Step 2: Improve the process

■ Establish a complete CSV process - including CSV Standard Operating Procedure’s (SOP) vendor audit procedures, a CSV lifecycle methodology, change control procedures, SOP deviation procedures, security procedures, back-up and restore procedures etc.

■ Implement operational CSV procedures - ensure that CSV procedures are well-linked to the system life cycle. Commence CSV activities with the initial project porposal and ensure continued integration of activities throughout the system development and maintenance process.

■ Develop and measure metrics - on both the CSV process and outcome of the process. Document the amount of time and money spent on CSV. Track and quantify quality issues, such as the number of software bugs, user complaints and the time to resolve errors. Determine a level of acceptable performance/quality and continuously improve the process until all goals are met.

Step 3: Leverage Existing Technologies

■ Construct templates for all required CSV documents - including outlines, sets of guidance for use and sample documentation. Offer flexibility in these templates, as projects may vary in size and complexity.

■ Invest in technologies - such as document management, version control and testing tools. Develop skills in these technologies, and leverage resources with these skills across projects. Promote use of these tools company-wide.

Step 4: Involve your people

■ Form the team - engage users, developers, testers, trainers, quality control and assurance, manufacturing and engineering is all CSV efforts. Organize representatives of the above groups into a cross-functional ‘validation team’, led by a validation coordinator. Assign responsibility to the team for developing and following the CSV process.

■ Set expectations - develop a set of qualified goals including cost effectiveness and system quality to be shared by all parties involved in the process.

■ Conduct training - conduct appropriate training for all parties involved-and document the training!

Free Consultation

Lack of return on CSV investments, time and cost overruns due to CSV, imbalance of cost and GMP compliance risk are typical symptoms of CSV overdone. We at Factorytalk believe this so strongly that we will support our customers during the educatioanl process through white paper, presentations, conferences, and in some cases, person-to-person assistance. We pledge that if we see the slightest symptom of CSV overdone, we will steer you from it. Why? Because nobody-you, your customers, your GMP inspector-needs it.

And, while CSV may be new to some people and customers may have questions, we will provide satisfying, understandable answers. Simply contact the Factorytalk team and “Call for a Coffee” for a free consultation.

We are located at :
Factorytalk Co., Ltd.
12th Floor, Liberty Square
287 Silom Road
Bangrak, Bangkok
10500 Thailand
Telephone : +66 (2) 630-4525      
Facsimile : +66 (2) 630-4527

Factorytalk Pte Ltd
25 International Business Park,
#04-106-107A,
German Centre,
Singapore 609916
Telephone :  +65 6562 7634       
Facsimile : +65 6562 7635

E-mail Address :
contact@factory-talk.com