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Validation Service for computer-aided systems in the pharmaceutical industry
What does validation mean:
Validation is the documented proof that the means used are suitable for
producing a given pharmaceutical product in sustainable, safe and reproducible
ways to meet its specified characteristics.
Since computer-aided systems in this sense form a quality-relevant part of the manufacturing process, European and US regulatory authorities demand validation for these.
What does validation do for you:
The proof of quality for your manufacturing processes and systems matters
not just to customers and inspectors.
In the longer run, you achieve essential cost-savings by virtue of having
a product of permanently high quality, systematic fault remediation,and
well-regulated sequences.
The reason why we are able to help you with your validation:
Our validation service is based upon our own experiences. As developers
of the pharmaceutical PPS / MES software Scarabaeus+ we passed several supplier
audits according to FDA criteria, and as service provider we more than
once supported pharmaceutical businesses successfully in their validation
processes. We are as familiar with the needs of the pharmaceutical sector
as we are with the requirements made by European and US regulatory authorities.
Our staff is regularly trained in order to be always up to date in validation
matters.
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Validation area:
Our validation service covers SPS, standardized field equipment, micro-controllers, intelligent field equipment, standard software packages, configurable software packages, special applications, as well as devices linked to the computer system via interfaces, where applicable.
- Standards:
Our validation service orients itself by all relevant international regulations: GAMP 4 Guide for Validation of Automated Systems, EU GMP guideline, APV guideline "Computer-Aided Systems", FDA Guidance for Industry, 21 CFR Part 11.
- Services:
Our validation service will support you irregardless of whether you intend to validate your system prospectively (simultaneous with the implementation of the computer system) or retrospectively (after the implementation of the computer system).
- We will analyse which system parts are relevant to quality criteria and subject to validation.
- We will support you during supplier audits, e.g. with the help of time-proven checklists.
- We will advise you as to the development of your validation strategy, as to setting up your project organization, and as to estimating costs and schedule.
- We will steer your project team.
- We will set up all necessary documents, standard operating procedures (SOPs) and specifications.
- We will help you scan, assess and qualify all existing validation documents.
- We will support you in executing DQs, IQs, OQs and PQs and in setting up the corresponding
test schedules all the way up to the concluding validation report.
