Documentation in pharmaceutical industry constitutes a true responsibility.
The creation of electronic documents, the need for associating to them a life cycle (workflow), the need to authenticate them and to transmit them in full safety are the stakes for an optimisation of their management, but also for a relevant response to the requirements of the international regulatory agencies.
Electronic document technologies offer to industries subject to regulations the means:
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To accelerate review and/or approval. |
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to facilitate the assembly of the bulky documents. |
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to automate page-setting of the documents presented to inspection. |
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to simplify research of the documents in preparation, applicable (or "filed") thanks to many functionalities of indexing. |
Electronic Management of Documents in the pharmaceutical industry may bring huge improvements to:
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Quality Assurance. |
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Document Management constitutes a powerful tool for management, the distribution and the control of the operational procedures (SOPs), but also a means of placing references in internal documents. |
... and more generally...
Document Management applies to all the departments which must handle documents which are legally required (deviations, Change Controls, audits suppliers, etc), but also all those which wish to control the computerised management of internal processes such as the incidents or customer complaints etc.
The consultants of the Document Management Competency Centre of ADN can thus help you with:
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to eveluate the needs of the users. |
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to analyse the regulatory requirements for any documents generated and stored. |
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to model a process or existing system. |
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to validate a software solution. |
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to be used in the audit of suppliers. |
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to write the validation file associated with this system,. |
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to ensure follow-up and maintenance (lifecycle). |
