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"Compliance" and "validation" are two key words in biotech and pharmaceutical companies. The process of introducing a new drug or a new biotechnological process to market is spread out over years and spans multiple departments within a company. The task of keeping track of progress on individual projects is very complicated.
Biotech and pharmaceutical companies need to have detailed audit trails on the creation and modification of various documents during the development of a drug or a process. This is essential if drug dossiers are to be submitted to the FDA for approval. Any documents submitted to the FDA for validation, under 21CFR Part 11, are recommended to be easily searchable and available in a human readable form. The audit trails in particular must be time-stamped to ensure their trustworthiness and reliability. This means that document management must be enterprise-wide, so that deliverables from all the users can be easily accessed and collated by the project managers, cutting down on the time needed for a company to prepare for validation.
Biotech and pharmaceutical companies are faced with the following challenges while managing the critical documents:
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High Costs:
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Biotech and pharmaceutical companies have their facilities and employees scattered in different locations. It might be cheaper to maintain separate records management systems for different locations, but the inefficiency of paper-based or stand alone systems becomes counterproductive and costs a lot of money in terms of man hours.
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Due to lack of collaboration and centralized knowledge repository, same documents have to be recreated over and over again costing a lot of money
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Storage and Search Issues:
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It is extremely difficult to search for paper documents and costs a lot in terms of time and man hours. According to 21CFR Part 11 for FDA validation, it is recommended that documents should be easily searchable and available in a human readable form.
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Paper documents require a lot of expensive storage space
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Communication Issues:
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In a paper-based systems, the document review process can be long and cumbersome. It requires a lot of meetings to discuss changes and obtain approval and signatures. When a change is rejected, more meetings are called for resulting in loss of time and man hours.
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- Tracing Audit Trail
- Biotech and pharmaceutical companies need to have detailed audit trails on the creation and modification of various documents during the development of a drug or a process. This is essential if drug dossiers are to be submitted to the FDA for approval. If a detailed audit trail is not available, it becomes very difficult for an organization to prepare for validation on time.
How can LuitDox SaaS help Biotech and Pharmaceutical Companies?
LuitDox SaaS can help biotech and pharmaceutical companies
streamline their documents and controlling audit trails of documents.
The following are the "before" and "after" effects
of implementing LuitDox SaaS:
| "Before"
using LuitDox SaaS |
"After"
using LuitDox SaaS |
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| Document
Management Challenges |
LuitDox
SaaS DMS Solution |
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Inefficient
paper-based Document Management System |
Efficient Document Management System | |||
Lack of document revision
control |
Automated document
revision control |
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Disconnected document
management processes |
Centralized document
management |
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Loss of knowledge and
organizational memory represented by knowledge and experiences |
Centralized knowledge
management repository for storing business critical documents
and knowledge for future reference and use |
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High costs of storage
and searching paper documents |
Advanced search functionality
makes searching documents very fast. Documents are stored in your
servers instead of filling hundreds of square feet of prime space
with file cabinets. |
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Lack
of oversight due to absence of a centralized reporting facility
on the document activities |
Increased visibility
due to document usage reports that can help in maintaining a record
of the document related activities performed by the different
employees |
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Inefficient audit trail
tracking in manual systems. |
Whenever a user takes a look or makes changes
in a document, the event is recorded in LuitDox SaaS and can be
used while applying for FDA vaildation of drugs |
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Inefficient
Workflow Process - A paper-based system is plagued by bottlenecks,
lack of follow up and inadequate response. All of these can result
in delayed approval of documents |
Efficient Workflow
Process - the easy to configure workflow process of LuitDox SaaS
helps biotech and pharmaceutical companies in streamlining document
approval processes |
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Loss of knowledge assets
and duplication of work |
Protect knowledge assets
to reduce the duplication of work and to enable organizations
to identify knowledge gaps using a easy-to-use system |
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| Expensive
employee training processes due to lack of training materials
in a centralized and searchable repository |
Reduce
training costs, improve learning and foster innovation by streamlining
information access and retrieval, putting content in context |
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Lack of a single system to reconfigure, recombine,
and integrate knowledge from distinct and disparate sources and
foster teamwork environment. |
LuitDox SaaS provides an adequate media to
reconfigure, recombine, and integrate knowledge from distinct
and disparate sources and supports effective team-working in environments
where teams are located physically together in the same office,
as well as virtual teams who do not necessarily meet face-to-face
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| Poor Follow-up - Assigning
team members and following up tasks via e-mail or phone is a time-consuming
process that could easily fall through the cracks |
Efficient
Follow-up - Automates review task assignment and follow-up via
alerts for any task not completed by deadline. |
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Lack of Connectivity - Documents created
using disparate tools (Excel, Microsoft Word, Visio, audit applications,
etc.) in multiple facilities are hard to collect, collate, retrieve,
and are easily misplaced |
Connected - LuitDox SaaS connects all documents
under a single secure, centralized system that can be accessed
by users with access privileges from virtually anywhere |
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Unwarranted
legal exposure - Incriminating, sensitive documents need to be
expunged immediately after the required retention period to prevent
unwarranted legal exposure, a difficult task in a manual system. |
Controlled legal exposure
- With LuitDox SaaS a company doesn't have to keep sensitive records
longer than it needs to. Records can be retained according to
company policy. |
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