PH21 - Frequently Asked Questions
These are some frequently asked questions. We hope, the following answers will give you some more insight into our quality concept.
Does your company maintain a documented/certified quality assurance system?
Yes, the original manufacturer of the software, irl GmbH in Seeheim-Jugenheim was and still is ISO-9001 certified. Ph21 Services Ltd. was ISO9001:2008 certified in March 2011
What is the qualification of your staff?
Our staff consists of engineers holding German or international recognized diplomas. Our chief programmer was involved in the project from the very beginning (1993) and thus could accumulate a very intimate knowledge of the Windows® programming environment. We even could fix several bugs of the Windows system software itself.
What are your essential QA documents?
All the usual documents required by a quality-orientd working environment are available. This includes the Requirement Spec, Software Design Spec and comprehensive Software Validation Test Suites. This documentation is oriented on GAMP 5 recommendations.
Can you roughly lay out a revision change procedure?
External problem reports will be assigned an ID number (so-called 'F-Number') and entered into our problem report database. Suggestions for improvement and corrections issued internally by Ph21 Services Ltd. are handled the same way. If a critical amount of problems have accumulated or if a critical error has been reported, the project manager will establish a new change control run. Open problems will be selected from the problem report database, will be assigned to the current change control run by the project manager. Each resolved problem will be registered in the database. Each resolved problem will be verified for correctnes, then recorded as approved in the problem database. If all problems assigned to a change control run have been approved, a new revision will be released by the project manager. If also all related documentation has been updated, verified and approved, a new revision will be released by the project manager and made public to our distributors.
How is your customer support organized?
All incoming problem reports (phone, fax, mail, email) will be received by qualified personnel. Problems caused by operating faults or misunderstandings of the documentation will be processed immediately or ASAP. Critical errors will cause an immediate post-release-change process. Minor critical problems will be scheduled for the next regular change control run. Our distributor's representatives will be informed in case of critical errors via our internal web interface. Regular change control information will be published in Ph21 Services Ltd.'s home page section.
Do you provide customer audits at your site?
Because of the expenses in time an labour force we favor remote/postal audits
Is the PH21 a "Standard Software"?
Yes, after the Ph21 system being in use for more than twenty years at customer locations all over the world we regard the Ph21 system as a 'Standard system'. Even though we are not compareable in size with famous manufacturers of, for example "Office" software products, PH21 is a well known and commonly accepted standard system in the pharmaceutical quality control of solid dosage forms field. Our products are in daily use at many major pharmaceutical corporations. Our PH21 system is ahead in functionality and useability of any other similar product. We thank all our customers for the valued suggestions and constructive critique which enabled us to improve the product continuously.
Dipl. Ing. Guenther A. Loeffler
Director/Owner of Ph21 Services Ltd.