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Advice You - Managing Flat File Storage Needs: A Case Study
For the manager of the Building Records unit at a major west coast public University, the document storage problems were critical. The problem wasn’t justifying budget for more space. There was no more spa
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
ce to be had.
The Facilities Management Department must preserve and keep accessible more than 40,000 original plans and drawings. Many of the documents date from the University’s founding and were hand d
The Facilities Management Department must preserve and keep accessible more than 40,000 original plans and drawings. Many of the documents date from the University’s founding and were hand d
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
awn by Architects and Engineers long gone. These include architectural, structural, civil, mechanical, plumbing, electrical and other drawings for site development, infrastructure, landscape, utilities, bu
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ldings, additions and renovations.
The 3,300-cubic-foot room holding the essentially irreplaceable documents was crammed seven feet high with flat files whose more than 150 drawers were filled to the top
The 3,300-cubic-foot room holding the essentially irreplaceable documents was crammed seven feet high with flat files whose more than 150 drawers were filled to the top
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
with originals. Clamped “sacrificials”—copies used to protect originals—are in a second room. Large E-size drawings were the most difficult to store and retrieve. Since the drawers had run out of space and
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
the University was still adding buildings and completing renovation projects, rolls of drawings were stacked everywhere.
The lowest files directly on the floor; bending and lifting risked minor injuries.
The lowest files directly on the floor; bending and lifting risked minor injuries.
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
eaving bottom drawers open presented a tripping hazard. Top drawers were stacked so high that staff could not see into them without stools or short ladders. And the aging drawers required frequent repairs.
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
The manager said: “Our filing structure had evolved over time and had no rhyme or reason,” so documents were prone to misfiling or not being filed. But the manager’s biggest concern was document longevit
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
. “Every use of an original abrades its clarity,” he points out. “Even sitting unused, drawings lying flat in the drawings rub each other when a truck shakes the building.”
Electronic Storage Costly and U
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
certain:
The manager was unconvinced about fully electronic storage. “Nobody’s going to provide more than $4 million to convert these documents to AutoCAD at $100 apiece,” he observes. “And you can’t pred
The manager was unconvinced about fully electronic storage. “Nobody’s going to provide more than $4 million to convert these documents to AutoCAD at $100 apiece,” he observes. “And you can’t pred
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ct which documents can be in cheaper graphics files versus those that must be in AutoCAD because you’ll someday need to manipulate them.”
“No electronic medium is as permanent and accessible as a document
“No electronic medium is as permanent and accessible as a document
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
. Today, you can’t play your old 8-track audiotapes. In a few years, you won’t find VCRs. And I’ve seen my CDs and DVDs wear. Every ten years, a new storage method will take over, so you’ll migrate your do
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
uments several times during your career. Each conversion costs money and opens the door to losing files or corrupted data.
“Properly stored, high-quality ink on Mylar has a functionally unlimited lifespan
“Properly stored, high-quality ink on Mylar has a functionally unlimited lifespan
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
” he points out. “Yet they’re subject to abrasion, misfiling, fire, and water. You need physical safety for your documents and electronic storage.”
“A new physical storage system had to let us grow, prote
“A new physical storage system had to let us grow, prote
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ct these documents far better, and offer a logical filing structure,” says the manager. In 17 years with other units within the University, he has developed cost-based methods of justifying projects. “We s
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
lected a vertical file storage system because it met our criteria at an affordable price. It was easy to work with, conversion was do-able, and it would eliminate injury dangers. Transitioning to a new fil
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ng system also provided an opportunity to implement a logical numbering system that the staff had developed but had not yet implemented".
“We calculated that vertical file storage systems were three times
“We calculated that vertical file storage systems were three times
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
more cost-effective than flat files,” says the manager. “We save space, our drawings hang without touching, finding documents is intuitive, and re-filing is easy so it gets done more regularly.”
The Univ
The Univ
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
rsity projects faster document retrievals during renovation projects and especially during an emergency. "Over-sized drawings were a pain," the University manager says, "but now we maintain them in vertica
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
file storage systems. One pleasant surprise was that, even fully loaded, staff can easily push the cabinets around on the carpeted floor, enabling fast cabinet rearrangement as needs change”.
Brad Barret
Brad Barret
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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