Validate computerised systems

Fulfilling this requirement is not just asked for by your QP and the QA/QC. This is actually a legal requirement. EU-GMP, 21 CFR Part 211/820 and 11 (USA), and similar requirements in other countries, force you to be able to demonstrate proper operation of your information systems across the full range (large ERP systems such as SAP, or small systems in laboratory devices or PLCs) at all times. Even though these regulations primarily concern logistical processes and product and patient safety, similar requirements have been present for commercial and financial processes for quite some time. Both accountants and tax authorities are always hot on your heels, demanding proof that your IT-supported processes are systemically safe. This circumstance and scandals rocking the public and the press, make business leaders and politicians aware of the topic at hand.

 Are you sure that you are in a position to prove IT compliance at all times? Do your project management, development, test procedures and reports, your SOPs for operations, change control and documentation structures all meet the quality requirements of the quality management system, and the validation/qualification plan as defined for the project? Are you aware of the systemic risks in respect of product safety and quality?

 

CSV, 21 CFR Part 11, Annex11/15 -- GAMP5 - Revolution or Evolution in CSV?

GAMP5® redefines the topic "economic validation" and "risk-based approach" from scratch. Are you aware of this, and are your CSV methodology and documentation standards "up to date"? read more...

 

ERP/SAP validation -- Lean ERP-validation: can this be done in a slim and cost effective manner?

"Validation drives costs! ... you cannot validate SAP®!" This type of prejudice has survived in the minds of operators and users of ERP systems, even after more than 15 years of validation. Previous validation procedures were in fact not always lean and cost-effective, but may have actually produced quite significant additional effort in the quality and professional departments. read more...

 

Excel validation

Fast and flexible spreadsheets with Microsoft EXCEL® (ESS) are essential when it comes to analysis, despite the availability of highly integrated LIMS and QM systems. Not infrequently, "umpteen" applications are in use at the same time, ranging from simple "stand-alone" systems through in-house development to outsourced, networked and macro-based programming. read more...

 

Infrastructure qualification

... can we still live without it? When the subject of "IT infrastructure qualification" was widely discussed for the first time a few years ago, it was considered sensational. There was a lot of talk, but nothing came of it except for a few pilot projects here and there. This was followed by a lengthy pause around the topic of IT infrastructure qualification, but now the topic has finally come of age. read more...

 

Laboratory equipment validation

Take advantage of the opportunities afforded by economic validation / qualification!

Today, Analytical Instrument Qualification (AIQ) and Computerised System Validation (CSV) have become processes in GMP laboratories. USP General Chapter and GAMP ®5 open up new possibilities for economic validation and qualification. Are you aware of this, and are your methodology and documentation standards "up to date"? read more...

 

The new CSV version as per ISO 13485-20xx (Medical Device Quality Management-Systems)

The draft revision of ISO 13485 for quality systems in medical technology places far more emphasis on the subject of CSV than the currently valid version. Are you aware of this, and are your systems "valid and up to date"? read more...

 

Our team of experienced, former IT managers from the pharmaceutical industry, and project managers / employees with many years of experience will approach these questions and tasks with you. We don't know any better than you, but we have different ideas, since we are familiar with many projects and clients.

Click here to see the reference projects for Computerised Systems Validation

 

For more information please contact Dr. Thomas Karlewski

Chemgineering Business Design AG | Binningerstrasse 2 | 4142 Münchenstein | T +41 61 467 89 00 | F +41 61 467 89 01 | www.chemgineering.com | info@chemgineering.com